[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"traumatic-brain-injury\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:traumatic-brain-injury":25},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,184,0,25,[9,39,68,89,115,153,175,198,224,244,267,287,316,340,366,396,419,451,477,511,532,563,589,620,642],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":38},"100627938","a-study-to-develop-a-blood-based-test-for-aiding-the-diagnosisprognosis-of-traumatic-brain-injury-in-adults-and-for-monitoring-the-development-of-secondary-events-in-patients-diagnosed-with-traumatic-brain-injury-100627938",false,"NCT07455136","A Study to Develop a Blood-based Test for Aiding the Diagnosis\u002FPrognosis of Traumatic Brain Injury in Adults and for Monitoring the Development of Secondary Events in Patients Diagnosed With Traumatic Brain Injury","A Multicenter Prospective Study to Develop a Blood-based Biomarker Test for Aiding the Diagnosis\u002FPrognosis of Traumatic Brain Injury in Adult Subjects (CLIN12.1) and for Monitoring the Development of Secondary Events in Patients Diagnosed With Traumatic Brain Injury (CLIN12.2)","Inclusion Criteria:\n\n* Presenting to the Emergency Department with a biomechanically plausible mechanism of non-penetrating traumatic brain injury (TBI; direct impact: blow to the head, head against object, object against head; acceleration\u002Fdeceleration)\n* Acute brain CT completed for standard of care\n\nFurther Inclusion Criteria (specific for CLIN12.2):\n\n* Admitted to the hospital with radiographic evidence of acute TBI\n* Admitted to the intensive care unit at risk for decline related to TBI\n\nExclusion Criteria:\n\n* Prior neurosurgical intervention within the last 6 months\n* Major debilitating neurological disease (such as, but not limited to: stroke, CVA, mild cognitive impairment, Alzheimer's disease, Amyotrophic lateral sclerosis, Parkinson's disease, Huntington's disease, Frontotemporal dementia, tumor, epilepsy, unmanaged seizure disorder), impairing baseline awareness, cognition, or validity of outcomes assessments\n* Major debilitating baseline mental health disorders (such as but not limited to schizophrenia or bipolar disorder) that would interfere with follow-up and the validity of outcome assessments\n* Significant pre-existing conditions that would interfere with follow-up and outcome assessment (such as, but not limited to: chronic kidney disease, chronic cardiovascular comorbidities, alcohol or substance use disorder)\n* History of melanoma\n* Primary diagnosis of ischemic or hemorrhagic stroke\n* Any spinal Cord Injury (American Spinal Injury Association \\[ASIA\\] score of A-D)\n* Received chemotherapy or radiation currently or within the last year\n* Patients on psychiatric hold (e.g., 5150, 5250)\n* Current incarceration or in custody\n* Known inability to undergo an MRI\n* Currently receiving any interventional treatments as a part of an investigational study\u002Ftrial (drug, device, behavioral, treatment) at the time of enrollment and\u002For during the course of this study\n* Low likelihood of follow-up (e.g. participant or family indicating low interest, residence in another state or country, homelessness or lack of reliable contacts)\n* Any condition that, in the opinion of the investigator, could interfere in the proper execution of the study procedures and\u002For in their future permanence in the study","ALL","18 Years",{"count":20,"type":21},2000,"ESTIMATED","OBSERVATIONAL","The study is intended to cover two purposes: first, to develop a blood-based biomarker test for aiding the diagnosis of traumatic brain injury (TBI) in adult participants and for prognosis of outcome of TBI (CLIN12.1); and second, for monitoring the development of secondary events in adult participants diagnosed with TBI (CLIN12.2).",[25],"Traumatic Brain Injury","RECRUITING","2026-08-20",{"date":29,"type":30},"2026-08-21","ACTUAL",{"date":32,"type":30},"2026-02-09",{"date":34,"type":21},"2028-11-23",{"name":36,"class":37},"Hoffmann-La Roche","INDUSTRY",14,{"id":40,"slug":41,"hasResults":12,"nctId":42,"briefTitle":43,"officialTitle":43,"acronym":44,"eligibilityCriteria":45,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":46,"enrollmentInfo":47,"targetDuration":4,"studyType":49,"phases":50,"briefSummary":52,"conditions":53,"keywords":54,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":59,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":67},"100457393","control-network-neuromodulation-to-enhance-cognitive-training-in-complex-traumatic-brain-injury-100457393","NCT05236010","Control Network Neuromodulation to Enhance Cognitive Training in Complex Traumatic Brain Injury","CONNECT-TBI","Inclusion Criteria:\n\nThere will be no gender restrictions with regard to sample inclusion. Veterans and Warfighters will be enrolled in this study if they 1) are aged 18-59; 2) have suffered a mild TBI with documented evidence of alteration in neurological functioning or loss of consciousness (LOC) which was less than 30 minutes; 3) were injured between 3 months and 5 years ago; 4) experienced less than 24 hours of post-traumatic amnesia (PTA); 5) have subjective post-TBI cognitive deficits as assessed by the NSI, with at least 1 of 4 cognitive symptoms at a score of 3 or higher (severe disturbance) or at least 2 of 4 cognitive symptoms at a score of 2 or higher (moderate disturbance). This is the target population as identified by the grant mechanism, with chronic cognitive impairments from mild traumatic brain injury. The age range of 18-59 years was selected because the investigators did not want to include developmental processes in analyses and by 18 years old, many major neurodevelopmental changes in the brain will have taken place. Using similar rationale, the investigators chose to include participants up to the age of 59 because they do not want to include advancing age-related brain changes in our analyses. They will also be 6) fluent in English, as the testing and intervention are all conducted in English; and 7) will have been on stable doses of any psychotropic medications for the past 2 months, so as to avoid confounding of results by medication effects. It is expected that the sample included in this study will reflect the demographics of the greater Albuquerque and Twin Cities metropolitan communities.\n\nExclusion Criteria:\n\nVeterans will be excluded from participation in this study if there is 1) a prior history of other neurological disease or any history of seizures beyond immediate post-traumatic seizure, so as to reduce risk of exacerbation of epilepsy or other neurological symptoms; 2) history of psychosis, so as to reduce risk of psychiatric decompensation; 3) history of current or recent (within two years) substance\u002Falcohol dependence, to reduce confounding effects on cognition; 4) any discontinuity in skull electrical conductivity (i.e., unhealed burr holes in scalp) or artificially constructed (metal or plastic) craniotomy cover, to reduce risk of unimpeded electrical current; 5) presence of any implanted metal or electrical device (e.g. pacemaker), to reduce risk of heating during MRI, or device malfunction during neuromodulation; 6) recent medical hospitalization (within three weeks), to reduce risk of medical decompensation during the study; 7) any condition that would prevent the participant from completing the protocol, such as significant agitation; 8) appointment of a legal representative, as assessed via direct inquiry of the participant or a designated trusted other, to avoid coercion of a vulnerable population; 9) any significant hardness of hearing or blindness that would make completing the cognitive training not possible; 10) any ongoing litigation related to TBI, to prevent interference with legal proceedings; 11) any other contraindication to exposure to strong magnetic fields or MRI, such as severe claustrophobia; 12) pregnant women will be excluded as the effects of MRI and brain stimulation on developing fetuses are unknown; 13) membership in an identified vulnerable population, including minors, and prisoners, and adults unable to consent due to cognitive impairment will be excluded, as they will be unlikely to be able to complete study procedures. Prisoners will be excluded from the study to avoid coercion; 14)received a Glasgow coma scale (GCS) less than 13 or greater than 15 upon ED admission, if available in patient's records.\n\nThe investigators do not intend to include adults who are unable to consent in this study.\n\nThe investigators do not intend to include individuals who are not yet adults (infants, children, teenagers) in this study.\n\nThe investigators do not intend to include pregnant women in this study.\n\nThe investigators do not intend to include prisoners in this study.","59 Years",{"count":48,"type":21},108,"INTERVENTIONAL",[51],"NA","The CONNECT-TBI Trial aims to develop safe, effective treatments for complex mTBI that improve cognitive functioning. Based on the compelling preliminary data generated by our study team, the objective of this study is to conduct a randomized, double-blinded, sham-controlled Phase II clinical trial of APT-3 combined with rTMS, HD-tDCS, or sham to treat cognitive control deficits in Veterans with complex mTBI and PPCS. At the Baseline Visit, participants will undergo demographic, neuropsychological, behavioral, and quality of life testing. They will also undergo structural MRI to permit modeling of their brain, resting\u002Ftask-related fMRI to identify the CCN, and pseudocontinuous arterial spin labeling (pCASL) and diffusion tensor imaging (DTI) to assess for other pathologies. They will then be randomized to 16 sessions of APT-3 with concurrent rTMS, HD-tDCS, or sham stimulation delivered to the unique functional left dorsolateral prefrontal cortex (DLPFC), a primary node of the CCN. Lastly, they will repeat all baseline tests, and report on 3- and 6-month recovery levels to establish longevity and stability of subjective benefit. Given that this individualization protocol has never been attempted for cognitive rehabilitation in military mTBI, we expect this trial will generate useful effect sizes for HD-tDCS and rTMS to be used for powering the next step, a Phase III multi-center trial.",[25],[25,55,56,57,58],"mTBI","Prolonged Post Concussive Symptoms","Brain Stimulation","Cognitive Rehabilitation",{"date":29,"type":30},{"date":61,"type":30},"2022-01-21",{"date":63,"type":21},"2026-10-01",{"name":65,"class":66},"University of New Mexico","OTHER",5,{"id":69,"slug":70,"hasResults":12,"nctId":71,"briefTitle":72,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":12,"sex":17,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":78,"conditions":79,"keywords":4,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":4},"100652871","diagnostic-accuracy-of-bedside-optic-nerve-sheath-diameter-ultrasonography-for-detecting-raised-intracranial-pressure-compared-with-brain-ct-findings-in-children-with-traumatic-brain-injury-100652871","NCT07780279","Diagnostic Accuracy of Bedside Optic Nerve Sheath Diameter Ultrasonography for Detecting Raised Intracranial Pressure Compared With Brain CT Findings in Children With Traumatic Brain Injury","Inclusion Criteria:\n\n* 1\\. Children aged 6-12 years. 2. Patients presenting within 24 hours of traumatic brain injury. 3. Patients undergoing brain CT based on emergency department and neurosurgical assessment.\n\n  4\\. Patients with traumatic brain injury of any severity, as assessed by the Paediatric Glasgow Coma Scale (PGCS).\n\n  5\\. Haemodynamically stable patients who can undergo ocular ultrasonography.\n\nExclusion Criteria:\n\n* 1\\. Orbital fractures, globe rupture, extensive periorbital oedema preventing right ONSD measurement.\n\n  2\\. Earlier intracranial surgery or ventriculoperitoneal shunt. 3. Known congenital or got neurological disorders associated with altered intracranial pressure (e.g., hydrocephalus or intracranial tumours).\n\n  4\\. Patients transferred after receiving osmotherapy before the initial ONSD measurement.","6 Years","12 Years",{"count":77,"type":21},100,"Traumatic brain injury (TBI) is a major cause of morbidity and mortality among children globally, with an estimated incidence ranging from 47 to 280 cases per 100,000 children (1). The burden of pediatric traumatic brain injury (pTBI) in low- and middle-income countries (LMICs) is characterized, because most pTBI occurs in LMICs (2). TBIs can have both short- and long-term effects including impairment of physical, cognitive, or emotional functions (3). Advances in acute trauma care have decreased mortality rates (4). Elevated intracranial pressure (ICP) following TBI or stroke has been recognized as an important second insult that is strongly correlated with increased mortality. Therefore, an increase in ICP can cause a decrease in brain perfusion and may result in brain ischemia (5). Early detection of raised intracranial pressure (RICP) is considered a better strategy to prevent secondary brain insult (6). The gold standard for ICP measurement is invasive techniques (i.e., ventriculostomy and intraparenchymal microtransducers), associated with risks, such as infection and haemorrhage (7). Several methods for noninvasive measuring of elevated ICP have been proposed: radiologic methods including computed tomography and ophthalmological techniques (8). Some brain computed tomography (CT) findings, such as brain parenchymal swelling, midline shifting, and compressed basal cisterns, are traditionally used for the indirect measurement of raised ICP (9). Among non-invasive methods, the measurement of optic nerve sheath diameter (ONSD) has gained particular interest (7). The optic nerve sheath is continuous with the meninges of the central nervous system and is encased with the subarachnoid membrane. Cerebrospinal fluid (CSF), located in the subarachnoid space, accumulates in the optic nerve sheath, thereby widening its diameter in the setting of increased ICP and limited intracranial compliance (10). Ultrasound assessments of ONSD could be a better option because of the low cost and rapid bedside operation without the need for radiation exposure, especially for cases that are unstable and require real-time monitoring of ICP in an intensive care unit (11). Despite existing research, there remains a gap in evaluating the diagnostic accuracy of the ONSD measured via ultrasound for the prediction of increased ICP in pediatric patients (12). This study aims to assess the diagnostic accuracy of bedside optic nerve sheath diameter ultrasonography for detecting raised intracranial pressure in pediatric traumatic brain injury using brain CT findings as the reference standard.",[25],"NOT_YET_RECRUITING","2026-08-19",{"date":29,"type":30},{"date":84,"type":21},"2026-10",{"date":86,"type":21},"2027-12",{"name":88,"class":66},"Assiut University",{"id":90,"slug":91,"hasResults":12,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":4,"eligibilityCriteria":95,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":96,"targetDuration":4,"studyType":49,"phases":98,"briefSummary":99,"conditions":100,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":114},"100652002","electrical-stimulation-exercise-for-individuals-with-lower-limb-paralysis-100652002","NCT07768761","Electrical Stimulation Exercise for Individuals With Lower Limb Paralysis","Efficacy of Electrical Stimulation Exercise Training for Those With Lower Limb Paralysis","Inclusion Criteria:\n\n* Lower limb paralysis due to SCI or other neurological disorder\n* Greater than 18 years of age\n* Innervated and excitable lower extremity muscles\n\nExclusion Criteria:\n\n* Females that are pregnant\n* Ventilator dependent\n* Current pressure injuries that would be exacerbated by exercise\n* History of spontaneous fractures\n* Cardiovascular or pulmonary disease that would limit the ability to exercise\n* Uncontrolled diabetes or hypertension\n* Large body frame that would prevent participant from comfortably fitting the exercise equipment\n* Any other medical or psychological condition that would be a contraindication to participating in an exercise program",{"count":97,"type":21},60,[51],"The purpose of this research study is to evaluate the effectiveness of an exercise training intervention (24-36 sessions) to improve muscle strength and endurance in the lower limbs of individuals with paralysis. Specifically, surface electrical stimulation or previously implanted stimulator will be used to stimulate the muscles during various forms of exercise training with the primary focus on improving overall endurance and maximal power output. For this study, peripheral stimulating electrodes will send electrical signals to the muscles enabling the production of coordinated movements for exercise such as cycling or rowing.",[101,102,103,25],"Spinal Cord Injury\u002FDisorder","Stroke","Multiple Sclerosis","2026-08-14",{"date":106,"type":30},"2026-08-17",{"date":108,"type":30},"2018-01-19",{"date":110,"type":21},"2031-01-19",{"name":112,"class":113},"Louis Stokes VA Medical Center","FED",1,{"id":116,"slug":117,"hasResults":12,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":121,"eligibilityCriteria":122,"healthyVolunteers":12,"sex":17,"minAge":123,"maxAge":124,"enrollmentInfo":125,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":127,"conditions":128,"keywords":134,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":114},"100652345","bedside-cranial-ultrasound-for-risk-stratified-imaging-in-pediatric-acute-brain-injury-100652345","NCT07772323","Bedside Cranial Ultrasound for Risk-Stratified Imaging in Pediatric Acute Brain Injury","Bedside Cranial Point-of-Care Ultrasound (cPOCUS) for Risk-Stratified Imaging in Pediatric Acute Brain Injury: A Prospective Diagnostic-Accuracy and Longitudinal Biomarker Cohort Study (CUPID-Peds)","CUPID-Peds","Inclusion Criteria:\n\n* Children 2 to 17 years of age\n* Undergoing a clinically indicated (standard-of-care) head CT for suspected acute brain injury (including trauma, headache with neurologic findings, altered mental status, focal deficit, seizure, post-cardiac-arrest, oncologic neurologic emergency, or intracranial infection)\n* Seen in the pediatric Emergency Department or Pediatric Intensive Care Unit at the Children's Hospital of Richmond at VCU (CHoR-VCU)\n* Consent obtainable from a legally authorized representative (LAR)\n* Cranial ultrasound feasible within the protocol time window (within 6 hours of head CT)\n\nExclusion Criteria:\n\n* Open skull fracture\n* Prior hemicraniectomy\n* Cranial surgical defect at the insonation site\n* Anticipated transition to comfort-only care\n* Any clinical condition in which cranial ultrasound would delay a time-critical intervention","2 Years","17 Years",{"count":126,"type":21},220,"Acute brain injury (ABI) is a leading cause of death and long-term disability in children. Diagnosis depends on fast neuroimaging, and head computed tomography (CT) is the bedside reference standard despite exposing the developing brain to ionizing radiation. A safe, portable, radiation-free bedside tool is needed to help decide which children need a head CT, to speed CT when injury is present, and to safely monitor injured children between scans. This study evaluates B-mode cranial point-of-care ultrasound (cPOCUS) performed through the temporal (and frontal) bone windows in children undergoing a clinically indicated head CT in the pediatric emergency department (ED) and pediatric intensive care unit (PICU). Children's thin skulls provide adequate acoustic windows in more than 95% of cases. cPOCUS is acquired by trained research scanners within 6 hours of head CT and interpreted offline by two blinded expert readers; the radiology CT report is the diagnostic gold standard. This is a prospective observational study; cPOCUS results are not returned to the clinical team in real time and do not change clinical care.",[129,25,130,131,102,132,133],"Acute Brain Injury","Intracranial Hemorrhage","Hydrocephalus","Brain Neoplasm","Hypoxia-Ischemia, Brain",[135,136,137,138,139,140,141,142,143,144],"cranial ultrasound","point-of-care ultrasound","cPOCUS","transcranial B-mode ultrasound","pediatric neuroimaging","head CT","midline shift","diagnostic accuracy","radiation reduction","neurocritical care","2026-08-13",{"date":81,"type":30},{"date":148,"type":21},"2026-11-30",{"date":150,"type":21},"2028-11-30",{"name":152,"class":66},"Virginia Commonwealth University",{"id":154,"slug":155,"hasResults":12,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":4,"eligibilityCriteria":159,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":160,"targetDuration":4,"studyType":49,"phases":162,"briefSummary":163,"conditions":164,"keywords":165,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":168,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":114},"100595933","overground-virtual-reality-vr-gait-rehabilitation-for-traumatic-brain-injury-tbi-100595933","NCT07038889","Overground Virtual Reality (VR) Gait Rehabilitation for Traumatic Brain Injury (TBI)","Investigating the Feasibility and Translational Therapeutic Benefits of Overground, Fully Immersive Virtual Reality (VR) Gait Rehabilitation Therapies for Individuals With Traumatic Brain Injury (TBI)","Inclusion Criteria:\n\n* Diagnosis: A confirmed diagnosis of traumatic brain injury (TBI), confirmed by the referring physician.\n* Cognitive Function: Mini-Mental State Examination (MMSE) score ≥ 24 or Montreal Cognitive Assessment (MoCA) score ≥ 20, indicating sufficient cognitive function to participate in the study.\n* Exercise Clearance: Approval from a physician for participation in exercise-based interventions.\n* Rehabilitation Need: Demonstrates a need for functional rehabilitation.\n* Recent Therapy: Participants should not have received physical therapy (PT) within the last month.\n* Consent: Must be able to provide informed consent for themselves.\n\nExclusion Criteria:\n\n* Participants with unstable medication regimens that could interfere with their participation in the study.\n* Any comorbidity that could interfere with walking or gait training.\n* Participation in VR-assisted gait training within the last 6 months.\n* Intolerance to virtual reality environments or motion simulation.\n* Severe cognitive, visual, or hearing impairments where the participant cannot follow the therapist's instructions.\n* More than 135 kg total body weight.\n* More than 2.00 meters in body height.\n* Presence of open skin lesions or bandages in areas that would come into contact with the harness.\n* Functional Ambulation Category (FAC): Participants with an FAC score of less than 2 indicate they require physical support from more than one person to walk.\n\nClarification:\n\n\\- The diagnosis of TBI can be confirmed by their physician or a physical therapist referring to the patient. If a physical therapist makes the referral, the diagnosis must still be officially confirmed by a physician to ensure it meets the study's medical criteria.",{"count":161,"type":21},30,[51],"The purpose of this study is to evaluate a new virtual reality (VR)-based rehabilitation program designed to help individuals with traumatic brain injury (TBI) improve their walking abilities in real-world settings. By comparing immersive VR-assisted overground gait therapy to contemporary non-immersive, treadmill-based VR therapy (i.e., C-Mill), the investigators aim to determine its effectiveness in enhancing mobility and quality of life for TBI patients.",[25],[166,167,25],"Gait Training","Virtual Reality",{"date":106,"type":30},{"date":170,"type":21},"2026-08",{"date":172,"type":21},"2027-06",{"name":174,"class":66},"Indiana University",{"id":176,"slug":177,"hasResults":12,"nctId":178,"briefTitle":179,"officialTitle":180,"acronym":4,"eligibilityCriteria":181,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":182,"targetDuration":4,"studyType":49,"phases":184,"briefSummary":185,"conditions":186,"keywords":190,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":192,"startDateStruct":193,"completionDateStruct":194,"leadSponsor":196,"locationsCount":4},"100578920","ai-driven-personalized-exercise-feedback-program-on-exercise-adherence-in-traumatic-brain-injury-100578920","NCT06817564","AI-driven Personalized Exercise Feedback Program on Exercise Adherence in Traumatic Brain Injury","Effects of an AI-driven Personalized Exercise Feedback Program on Exercise Adherence and Health Outcomes in Patients With Traumatic Brain Injury","Inclusion Criteria:\n\n* Eligible participants are patients aged over 18 with mild TBI (GCS 13-15)\n* who can walk independently,\n* reside in the Greater Taipei area,\n* and possess sufficient Chinese or Taiwanese language proficiency to understand the trial\n* complete self-administered questionnaires.\n\nExclusion Criteria:\n\n* include individuals with severe medical conditions (e.g., respiratory failure, epilepsy, psychiatric disorders), musculoskeletal or neurological impairments\n* hindering physical activity in the 6-minute walk test,\n* cognitive impairments (MMSE \\\u003C 24),\n* frontal lobe injuries or penetrating injury causing significant psychological dysfunction.\n* Patients regularly engaging in moderate-to-high-intensity aerobic exercise or participating in other studies will also be excluded to avoid bias.",{"count":183,"type":21},125,[51],"This study aims to develop and evaluate an AI-driven Personalized Exercise Feedback Program (AI-PEF) to enhance exercise adherence and health outcomes in mTBI patients.\n\nMethods: AI-PEF integrates the transtheoretical model and self-determination theory with machine learning algorithms to provide real-time, personalized feedback. A phased randomized controlled trial will be conducted: Phase I evaluates feasibility and acceptability through Delphi methods with expert consensus and patient feedback; Phase II validates preliminary outcomes with 30 participants in a 2-arm randomized trial; and Phase III assesses the program's impact on exercise adherence, exercise motivation, mHealth app usability, functional capacity, sleep quality, depressive symptoms, concussion symptoms, and quality of life with 90 participants in a 3-arm randomized trial. In Phase III, quantitative and qualitative data will be collected in parallel, with qualitative data collected through semi-structured interviews to explore participants' experiences and perceptions of the intervention.",[25,187,188,189],"Exercise","AI (Artificial Intelligence)","Digital Health",[191],"AI-Driven Personalized Exercise Program",{"date":106,"type":30},{"date":106,"type":21},{"date":195,"type":21},"2031-08-31",{"name":197,"class":66},"National Defense Medical Center, Taiwan",{"id":199,"slug":200,"hasResults":12,"nctId":201,"briefTitle":202,"officialTitle":203,"acronym":204,"eligibilityCriteria":205,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":206,"targetDuration":4,"studyType":49,"phases":208,"briefSummary":209,"conditions":210,"keywords":211,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":217,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":114},"100612678","hypnosis-and-attention-in-patients-with-a-neurological-disease-stroke-traumatic-brain-injury-and-multiple-sclerosis-100612678","NCT07256704","Hypnosis and Attention in Patients With a Neurological Disease (Stroke, Traumatic Brain Injury and Multiple Sclerosis)","Hypnosis and Attention in Patients With a Neurological Disease","HYPNOVA","Inclusion Criteria:\n\n* ICD-10 Diagnosis of stroke, TBI or MS\n* Admitted to the inpatient and\u002For outpatient in the Clinic for Neurology and Neurorehabilitation\n* Age 18 years old or older\n* Understanding the German language\n* Written informed consent\n\nExclusion Criteria:\n\n\\- Psychiatric disease\n\nExclusion criteria for the EEG:\n\n\\- Scalp or skin conditions that interfere with EEG electrode placement (e.g. open wounds, infections, severe psoriasis) Implanted medical or neurostimulation devices that interfere with EEG electrode placement (e.g. deep brain stimulators, cochlear implants)",{"count":207,"type":21},48,[51],"This feasibility study investigates the potential of hypnosis as a complementary therapy for improving attentional deficits and reducing fatigue in patients with neurological conditions such as stroke, traumatic brain injury (TBI), and multiple sclerosis (MS). These patients often experience reduced spontaneous visual exploration and impaired functional independence despite current rehabilitation approaches. By integrating hypnosis with standard care and using EEG to monitor brain activity during hypnosis and sham-hypnosis sessions, this trial aims to evaluate the feasibility, acceptability, and preliminary efficacy of hypnosis in enhancing attention and reducing fatigue.",[102,25,103],[212,213,214,215],"Hypnosis","Attention deficit","Neurorehabilitation","Electroencephalography (EEG)","2026-08-12",{"date":104,"type":30},{"date":219,"type":30},"2025-11-18",{"date":221,"type":21},"2029-07-31",{"name":223,"class":66},"Luzerner Kantonsspital",{"id":225,"slug":226,"hasResults":12,"nctId":227,"briefTitle":228,"officialTitle":229,"acronym":4,"eligibilityCriteria":230,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":231,"targetDuration":4,"studyType":49,"phases":233,"briefSummary":235,"conditions":236,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":237,"startDateStruct":238,"completionDateStruct":240,"leadSponsor":242,"locationsCount":114},"100538627","phase-2-understanding-and-treating-traumatic-brain-injury-tbi-associated-photophobia-with-botulinum-toxin-type-a-bont-a-100538627","NCT06293300","Understanding and Treating Traumatic Brain Injury (TBI) Associated Photophobia With Botulinum Toxin Type A (BoNT-A)","Understanding and Treating TBI Associated Photophobia With Botulinum Toxin Type A and Its Impact on Visual Function","Inclusion Criteria:\n\n* Recruit and enroll male and female subjects, civilians and veterans (1:1 mix anticipated, i.e., n = 25 from each group) of all races and ethnicities.\n* ≥18 years of age who are able to consent.\n* Report chronic photophobia (Numerical Rating Scale ≥4 on a 0-10 scale, photophobia present ≥6 months) with a remote history of TBI (\\>1 year).\n* Inclusion into the study with regard to TBI status will be based on the Department of Defense Standard Surveillance Case Definition for TBI Adapted for Armed Forces Health Surveillance Division (AFHSB) Use. This can include one hospitalization or outpatient medical encounter with documented International Classification of Diseases (ICD9\u002FICD10) codes as identified within the Surveillance Case Definition.\n* Subjects must also have been on a stable medication regimen for the past 3 months and must be naïve to BoNT-A treatment for orofacial conditions.\n* English as primary language (by self-report).\n\nExclusion Criteria:\n\n* Individuals with ocular diseases that may confound photophobia, such as glaucoma, corneal and conjunctival scarring, corneal edema, uveitis, iris transillumination defects, retinal degeneration, etc.\n* Patients who are participating in another study with an investigational drug within one month prior to screening.\n* Pregnant individuals. Pregnant subjects will not be scanned in the functional Magnetic Resonance Imaging (fMRI). Although there are no known risks associated with MRI during pregnancy, according to facility policy, University of Miami will not scan someone that is pregnant. Therefore, all women of childbearing potential (menstruating or \\>12 years old) must complete a for stating that are not pregnant within 24 hours of each MRI scan.\n* Individuals with contraindications to fMRI scanning (e.g. metal implants, pacemaker) will not be offered inclusion.",{"count":232,"type":21},50,[234],"PHASE2","The purpose of this research is to understand and treat Traumatic Brain Injury (TBI) associated photophobia (light sensitivity) and its impact on visual function.",[25],{"date":104,"type":30},{"date":239,"type":30},"2024-09-30",{"date":241,"type":21},"2027-09-30",{"name":243,"class":66},"University of Miami",{"id":245,"slug":246,"hasResults":12,"nctId":247,"briefTitle":248,"officialTitle":248,"acronym":249,"eligibilityCriteria":250,"healthyVolunteers":12,"sex":17,"minAge":251,"maxAge":252,"enrollmentInfo":253,"targetDuration":4,"studyType":49,"phases":255,"briefSummary":256,"conditions":257,"keywords":4,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":259,"lastUpdatePostDateStruct":260,"startDateStruct":261,"completionDateStruct":263,"leadSponsor":265,"locationsCount":4},"100648363","paired-vns-for-tbi-rehabilitation-100648363","NCT07719829","Paired VNS For TBI Rehabilitation","VNS for TBI","Inclusion Criteria:\n\n* Age 22-80 years\n* History of severe TBI (initial GCS ≤ 8)\n* Regained consciousness with capacity to consent to the study\n* At least six months since injury\n* Full recovery of consciousness with command following (mGCS = 6)\n* Ongoing motor impairment with dependence in activities of daily living (modified Rankin Scale, mRS = 3-4)\n* Clinically stable for VNS implantation\n\nExclusion Criteria:\n\n* No capacity to consent to the study\n* History of stroke\n* History of cognitive disorder or other neurodegenerative disorder\n* History of epilepsy treated by VNS\n* History of brain tumors (primary or metastatic)\n* Requires diathermy\n* Pregnant\n* Previously implanted vagus nerve stimulator\n* Extensive prior neck surgery preventing dissection of the vagus nerve\n* History of severe spasticity, vagus nerve damage, or hearing loss","22 Years","80 Years",{"count":254,"type":21},20,[51],"This study is evaluating whether pairing vagus nerve stimulation (VNS) with structured upper limb rehabilitation therapy can improve arm and hand function in individuals with chronic moderate to severe traumatic brain injury (TBI) and subsequent motor deficits.\n\nMany people who survive a TBI experience long-term weakness, poor coordination, and difficulty using one arm or hand. These motor impairments can significantly affect independence and quality of life. Traditional rehabilitation can help, but recovery is often incomplete.\n\nVagus nerve stimulation (VNS) is an FDA-approved therapy for certain neurological conditions and involves a small device implanted under the skin in the chest with a lead connected to the vagus nerve in the neck. The device delivers mild electrical pulses to the nerve. In this study, VNS will be paired with goal-directed upper limb rehabilitation exercises. The stimulation is delivered during specific movements in therapy sessions. This \"paired stimulation\" approach is designed to enhance neuroplasticity - the brain's ability to reorganize and form new connections - which may improve motor recovery.\n\nThe VNS device used in this study is FDA-approved for other conditions. However, its use paired with rehabilitation for upper limb recovery after traumatic brain injury is investigational.\n\nParticipants in this study will:\n\nUndergo surgical implantation of the VNS device.\n\nParticipate in structured upper limb rehabilitation therapy sessions where stimulation is paired with specific movements.\n\nComplete follow-up visits and assessments to measure changes in arm and hand function, strength, dexterity, and overall recovery.\n\nThe main goal of the study is to determine whether paired VNS and rehabilitation improves upper limb motor function compared to rehabilitation alone. Safety will also be closely monitored, including surgical outcomes and any device-related effects.\n\nThis study may help determine whether VNS paired with rehabilitation is a safe and effective way to enhance motor recovery after traumatic brain injury. Findings from this research could contribute to improved treatment strategies for individuals living with long-term motor impairments following TBI. If the results are promising, future studies plan to also include patients with acute TBI.\n\nParticipation is voluntary. All participants will be carefully evaluated to determine eligibility, and informed consent will be obtained before enrollment.",[25,258],"TBI (Traumatic Brain Injury)","2026-08-11",{"date":145,"type":30},{"date":262,"type":21},"2027-01",{"date":264,"type":21},"2031-12",{"name":266,"class":66},"Stony Brook University",{"id":268,"slug":269,"hasResults":12,"nctId":270,"briefTitle":271,"officialTitle":272,"acronym":4,"eligibilityCriteria":273,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":274,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":276,"conditions":277,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":279,"lastUpdatePostDateStruct":280,"startDateStruct":281,"completionDateStruct":283,"leadSponsor":285,"locationsCount":114},"100487524","evaluation-of-the-scaled-scaling-acceptable-cds-100487524","NCT05628207","Evaluation of the SCALED (SCaling AcceptabLE cDs)","Evaluation of the SCALED (SCaling AcceptabLE cDs) Approach for the Implementation of Interoperable CDS for Venous Thromboembolism Prevention - CDS Data","Inclusion Criteria:\n\n* age 18 and older\n* admitted with a TBI\n\nExclusion Criteria:\n\n* Patients who die within 24 hours of hospital admission and patients documented as \"comfort cares\" during the first 72 hours of hospitalization or with mild TBI will be excluded from final analysis.",{"count":275,"type":21},15000,"This project will adapt a currently deployed Clinical Decision Support (CDS) system to deliver a VTE prevention guideline for adult patients with traumatic brain injury (TBI). We believe this is an ideal PCOR use case given PCORI's continued effort to combat VTE in trauma and our experience previously implementing this guideline. The Our overall goal is to successfully scale, evaluate, and maintain an interoperable TBI CDS across 7 total institutions.",[25,278],"Venous Thromboembolism","2026-08-10",{"date":216,"type":30},{"date":282,"type":30},"2023-05-16",{"date":284,"type":21},"2026-09-30",{"name":286,"class":66},"University of Minnesota",{"id":288,"slug":289,"hasResults":12,"nctId":290,"briefTitle":291,"officialTitle":292,"acronym":293,"eligibilityCriteria":294,"healthyVolunteers":295,"sex":17,"minAge":18,"maxAge":296,"enrollmentInfo":297,"targetDuration":4,"studyType":49,"phases":298,"briefSummary":299,"conditions":300,"keywords":301,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":307,"lastUpdatePostDateStruct":308,"startDateStruct":309,"completionDateStruct":311,"leadSponsor":313,"locationsCount":315},"100649276","home-based-exergame-motor-cognitive-rehabilitation-for-traumatic-brain-injury-100649276","NCT07733336","Home-Based Exergame Motor-Cognitive Rehabilitation for Traumatic Brain Injury","Effectiveness of Home-Based Exergame Motor-Cognitive Rehabilitation Versus Outpatient Multidisciplinary Rehabilitation in Individuals With Traumatic Brain Injury: A Pilot Controlled Trial","HOME-TBI","TBI patients Inclusion Criteria\n\n* Discharge from intensive inpatient post-acute rehabilitation following a first traumatic brain injury (TBI).\n* Level of Cognitive Functioning Scale (LCF) score ≥ 6, indicating appropriate and goal-directed cognitive responses.\n* Ability to walk at least 30 meters, with or without an assistive device.\n* Ability to maintain an unsupported standing position for at least 3 minutes.\n* Provision of written informed consent.\n\nTBI patients Exclusion Criteria\n\n* Diagnosis or suspected diagnosis of a neurodegenerative disorder.\n* Previous history of traumatic brain injury.\n* History of major psychiatric disorders (e.g., schizophrenia or bipolar disorder), primary sleep disorders, or epilepsy.\n* Severe visual or auditory impairment that could interfere with study assessments or participation in the rehabilitation program.\n* Severe expressive and\u002For receptive aphasia.\n* Language barriers preventing reliable cognitive assessment or informed consent procedures.\n* Current pregnancy.\n\nHealthy Subjects - Exclusion Criteria\n\n* Presence of any neurological, sensrory, cognitive, psychiatric, cardiopulmonary, or musculoskeletal condition that may affect study participation or outcome measures\n* Language barriers preventing reliable cognitive assessment or informed consent procedures.\n* Current pregnancy.",true,"75 Years",{"count":161,"type":21},[51],"The goal of this clinical trial is to evaluate the effectiveness of a home-based cognitive-motor telerehabilitation program in individuals with traumatic brain injury (TBI) following discharge from intensive inpatient neurorehabilitation.\n\nThe main questions it aims to answer are:\n\n* Does home-based cognitive-motor telerehabilitation improve functional independence, cognitive performance, mobility, and quality of life in individuals with TBI?\n* Are the effects of home-based cognitive-motor telerehabilitation superior to those achieved with standard outpatient rehabilitation?\n\nThe study will compare a home-based cognitive-motor telerehabilitation program with standard outpatient rehabilitation to determine their relative effects on functional recovery.\n\nParticipants will:\n\n* Receive either home-based cognitive-motor telerehabilitation or standard outpatient rehabilitation, according to the assigned treatment pathway. Both rehabilitation programs consist of 20 sessions lasting 45 minutes each, three times per week.\n* Undergo clinical, cognitive, and motor assessments at predefined study time points: T0 (hospital discharge, pre-intervention), T1 (post-intervention, 7 weeks after T0), and T2 (follow-up, 6 months after T0).\n* Be evaluated for changes in functional independence, cognitive functioning, mobility, quality of life, and caregiver burden.",[25],[302,303,304,305,306],"Traumatic Brain Injury;","Telerehabilitation","motor function","cognitive function","multidisciplinary rehabilitation","2026-08-07",{"date":259,"type":30},{"date":310,"type":21},"2026-11-03",{"date":312,"type":21},"2029-03-31",{"name":314,"class":66},"Fondazione Don Carlo Gnocchi ETS",2,{"id":317,"slug":318,"hasResults":12,"nctId":319,"briefTitle":320,"officialTitle":321,"acronym":322,"eligibilityCriteria":323,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":324,"targetDuration":4,"studyType":49,"phases":326,"briefSummary":328,"conditions":329,"keywords":330,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":307,"lastUpdatePostDateStruct":333,"startDateStruct":334,"completionDateStruct":336,"leadSponsor":338,"locationsCount":114},"100537833","phase-1-safety-and-efficacy-of-angiotensin-1-7-in-persons-with-moderate-to-severe-traumatic-brain-injury-100537833","NCT06282965","Safety and Efficacy of Angiotensin (1-7) in Persons With Moderate to Severe Traumatic Brain Injury","A Randomized, Double-blind, Placebo Controlled Study of the Safety and Efficacy of Angiotensin (1-7) in Persons With Moderate to Severe Traumatic Brain Injury (TBI)","ANGel T","Inclusion Criteria:\n\n* Participant or representative willing to provide informed consent.\n* Age 18 years or older at time of enrollment.\n* Traumatically induced head injury resulting from insult to head from an external force.\n* Clinical diagnosis of acute intracranial lesion based on neuroradiologist report. CT scan and report must be available.\n* Moderate or severe traumatic brain injury (TBI) defined as Glasgow Coma Scale (GCS) score on trauma presentation of 12 or less. In general: Moderate TBI will be defined as loss of consciousness between 30 minutes and 24 hours and GCS between 9 and 12. Severe TBI will be defined as loss of consciousness \\> 24 hours and GCS ≤ 9.\n* Enrollment within 48 hours of TBI.\n\nExclusion Criteria:\n\n* Time of injury cannot be determined.\n* Neurosurgery within the last 30 days.\n* History of neurodegenerative disease or disorder including dementia, Parkinson's disease, multiple sclerosis, seizure disorder, or brain tumors that would impact cognitive testing.\n* Contraindication to having an MRI.\n* Pregnant or lactating female.\n* Female of childbearing potential or sexually active male who is not willing to use an acceptable method of birth control for the treatment period and 7 days after the last dose of the study drug.\n* Participation in another clinical study involving investigational product within 30 days prior to study enrollment.\n* If in the opinion of the investigator, candidate is unsuitable for participation in the study.",{"count":325,"type":21},90,[327,234],"PHASE1","The goal of this clinical trial is to test the safety of the drug Angiotensin (1-7) and learn whether it works well as a treatment in people who have suffered a moderate to severe traumatic brain injury (TBI).\n\nThe main questions this trial aims to answer are:\n\n* Is Angiotensin (1-7) safe?\n* Does Angiotensin (1-7) improve mental functioning and reduce physical signs of brain damage in people who have suffered a moderate to severe TBI?\n\nParticipants will:\n\n* Complete 21 days of study treatment consisting of a once-daily injection.\n* Provide blood samples.\n* Undergo two magnetic resonance imaging (MRI) scans of the brain.\n* Complete specific tasks and questionnaires that allow researchers to evaluate the participant's brain and psychological functioning.\n\nResearchers will compare three groups: two groups that receive different doses of Angiotensin (1-7) and one group that receives a look-alike treatment with no active drug. This will allow researchers to see if the drug has any negative effects and whether it improves mental functioning and physical signs of brain damage after a TBI.",[25],[331,332],"renin angiotensin system","cognition",{"date":259,"type":30},{"date":335,"type":30},"2024-05-28",{"date":337,"type":21},"2027-09",{"name":339,"class":66},"University of Arizona",{"id":341,"slug":342,"hasResults":12,"nctId":343,"briefTitle":344,"officialTitle":345,"acronym":346,"eligibilityCriteria":347,"healthyVolunteers":12,"sex":17,"minAge":348,"maxAge":349,"enrollmentInfo":350,"targetDuration":4,"studyType":49,"phases":352,"briefSummary":353,"conditions":354,"keywords":356,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":359,"lastUpdatePostDateStruct":360,"startDateStruct":361,"completionDateStruct":362,"leadSponsor":364,"locationsCount":4},"100651016","creatine-supplementation-in-pediatric-brain-injury-100651016","NCT07756060","Creatine Supplementation in Pediatric Brain Injury","Creatine Supplementation in Pediatric Brain Injury: Brain Outcomes Optimization Through Supplementation Therapy","BOOST","Inclusion Criteria:\n\n* History of subacute moderate-to-severe brain injury resulting in a new functional impairment, as defined by: Glasgow Coma Scale score (GCS) \\\u003C 13 points\n* Subacute brain injury is defined to be \\\u003C 3 months since index injury\n\nExclusion Criteria:\n\n* Weight \\\u003C 25 kg\n* History pre-existing chronic kidney disease (CKD stage ≥ 2), prior kidney transplantation, previous dialysis dependence, or solitary kidney status\n* Premorbid (pre-brain injury) eGFR \\\u003C 60\n* Inability to obtain regular phlebotomy for any reason\n* Known inborn errors of mitochondrial function\n* Premorbid history of significant head trauma or brain injury requiring hospitalization\n* Pregnancy\n* Concurrent malignancy\n* Any other current, serious, chronic medical or psychiatric disease that in the PI's judgment may interfere with study participation or data integrity","8 Years","25 Years",{"count":351,"type":21},46,[51],"A study examining the effects of creatine supplementation to improve recovery after brain injury in children and teenagers.",[355,25,102],"Brain Injury",[357,358],"creatine","rehabilitation","2026-08-04",{"date":279,"type":30},{"date":84,"type":21},{"date":363,"type":21},"2030-09",{"name":365,"class":66},"Spaulding Rehabilitation Hospital",{"id":367,"slug":368,"hasResults":12,"nctId":369,"briefTitle":370,"officialTitle":371,"acronym":4,"eligibilityCriteria":372,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":373,"enrollmentInfo":374,"targetDuration":4,"studyType":49,"phases":376,"briefSummary":377,"conditions":378,"keywords":382,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":359,"lastUpdatePostDateStruct":389,"startDateStruct":391,"completionDateStruct":392,"leadSponsor":394,"locationsCount":114},"100650564","zepu-2000-limb-rehabilitation-trainer-study-zepu2000rct-100650564","NCT07749612","ZEPU-2000 Limb Rehabilitation Trainer Study (ZEPU2000RCT)","Feasibility, Safety and Efficacy of ZEPU-2000A, ZEPU-2000D and ZEPU-2000E Upper and Lower Limb Active and Passive Rehabilitation Trainer Systems in Patients With Upper and Lower Limb Motor Dysfunction","Inclusion Criteria:\n\n* Presence of upper-limb motor dysfunction, with or without concurrent lower-limb impairment, due to one of the following: stroke with onset between 2 and 24 months prior to enrolment; incomplete spinal cord injury (neurological level C5 and below), classified as ASIA Impairment Scale C or D; traumatic brain injury with persistent upper-limb functional limitation; or orthopedic\u002Fpost-surgical conditions involving the shoulder, elbow, wrist, or hand with persistent functional impairment for more than 3 months\n* Age between 18 and 60 years\n* Ability to understand study procedures and follow instructions, and to provide written informed consent (or assent with guardian consent where applicable)\n* Body weight and limb anthropometry compatible with ZEPU-2000A, ZEPU-2000D, and ZEPU-2000E systems, per manufacturer specifications\n* Medically stable and cleared by a physician for robotic rehabilitation, with no active infection, uncontrolled cardiac or respiratory disease, severe osteoporosis, uncontrolled epilepsy, or untreated deep vein thrombosis\n\nExclusion Criteria:\n\n* Complete spinal cord injury or profound motor paralysis preventing safe interaction with robotic devices\n* Severe cognitive impairment, defined as a Mini-Mental State Examination (MMSE) score less than 24, that would compromise safe participation Severe spasticity of the upper limb, defined as a Modified Ashworth Scale score greater than 3\n* Unstable fractures, severe fixed joint contractures of the shoulder, elbow, wrist, or hand (e.g., greater than 30 degrees), or severe pain limiting safe robotic training\n* Uncontrolled cardiac arrhythmia, or presence of a pacemaker or other implanted electronic medical device incompatible with robotic sensors\n* Pregnancy","60 Years",{"count":375,"type":21},36,[51],"The goal of this clinical trial is to learn whether the ZEPU-2000A, ZEPU-2000D and ZEPU-2000E robotic rehabilitation trainers help people with weakness or movement problems in their arms and legs. These devices are used to guide repeated arm and leg movements as part of rehabilitation therapy. The study will also look at whether the devices are safe to use.\n\nThe main questions it aims to answer are:\n\nIs training with the ZEPU-2000 devices safe, and how well do patients tolerate and stick with the training sessions? Does adding robotic training to usual rehabilitation improve muscle strength, joint movement, balance, walking, and daily function more than usual rehabilitation alone?\n\nResearchers will compare a group receiving robotic-assisted rehabilitation plus usual care to a group receiving usual rehabilitation care alone, to see whether the robotic devices provide added benefit.\n\nParticipants will:\n\nBe adults aged 18-60 with arm and\u002For leg movement problems caused by stroke, incomplete spinal cord injury, traumatic brain injury, or an orthopedic condition Attend training sessions 3 times a week for 12 weeks (about 36 sessions total), each lasting approximately 45 minutes Undergo assessments of strength, movement, balance, and daily function at the start of the study and every 2 weeks throughout the 12-week period Be monitored for any side effects or safety concerns, such as skin irritation, falls, or discomfort, at every session",[102,379,25,380,381],"Incomplete Spinal Cord Injury (SCI)","Upper Extremity Motor Dysfunction","Lower Extremity Motor Dysfunction",[383,384,385,386,387,214,388],"Robotic rehabilitation","ZEPU-2000A","ZEPU-2000D","ZEPU-2000E","Active and passive rehabilitation","Musculoskeletal rehabilitation",{"date":390,"type":30},"2026-08-06",{"date":170,"type":21},{"date":393,"type":21},"2026-12",{"name":395,"class":66},"Bangladesh Medical University",{"id":397,"slug":398,"hasResults":12,"nctId":399,"briefTitle":400,"officialTitle":400,"acronym":4,"eligibilityCriteria":401,"healthyVolunteers":295,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":402,"targetDuration":4,"studyType":49,"phases":403,"briefSummary":404,"conditions":405,"keywords":406,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":359,"lastUpdatePostDateStruct":412,"startDateStruct":413,"completionDateStruct":415,"leadSponsor":417,"locationsCount":4},"100592172","treating-traumatic-brain-injury-with-transcranial-direct-current-stimulation-100592172","NCT06989970","Treating Traumatic Brain Injury With Transcranial Direct Current Stimulation","Inclusion Criteria:\n\n* Diagnosis of traumatic brain injury (TBI) at least 2 years prior to participation\n* Right-handed\n* English - speaking\n\nExclusion Criteria:\n\n* Uncorrected visual impairment\n* Uncorrected hearing impairment\n* Stroke or other premorbid neurological disorders affecting the brain\n* Premorbid learning disorders\n\nMRI Exclusion Criteria:\n\n* severe claustrophobia\n* Cardiac pacemakers, ferromagnetic implants, cochlear implants\n* pregnant woman",{"count":254,"type":21},[51],"Traumatic Brain Injury (TBI) often results in a wide array of cognitive impairments, which can significantly diminish quality of life for affected individuals. While traditional rehabilitation methods typically adopt a standardized approach, it's crucial to acknowledge the significant heterogeneity within the TBI patient population. Neglecting these variations reduces the likelihood of otherwise effective treatments being considered for widespread adoption. Emerging evidence highlights the potential of transcranial direct current stimulation (tDCS) as a promising adjunctive therapy. tDCS, a noninvasive and safe neuro-rehabilitative procedure, has shown efficacy when integrated with cognitive training across various neurological disorders, such as depression, post-stroke aphasia, and neurodegenerative conditions.\n\nThis study aims to investigate the effectiveness of tDCS paired with behavioral therapy, particularly cognitive training, in improving cognition and executive function in chronic TBI patients. Additionally, tDCs targets in the current study will be tailored to each individual patient, recognizing the patient's unique needs and circumstances",[25],[407,25,408,409,410,411],"TBI","Chronic Traumatic Brain Injury","transcranial direct current stimulation","tDCS","Computerized Cognitive Therapy",{"date":390,"type":30},{"date":414,"type":21},"2026-09-15",{"date":416,"type":21},"2029-10-15",{"name":418,"class":66},"Johns Hopkins University",{"id":420,"slug":421,"hasResults":12,"nctId":422,"briefTitle":423,"officialTitle":424,"acronym":425,"eligibilityCriteria":426,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":427,"targetDuration":4,"studyType":49,"phases":429,"briefSummary":430,"conditions":431,"keywords":434,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":442,"lastUpdatePostDateStruct":443,"startDateStruct":445,"completionDateStruct":447,"leadSponsor":449,"locationsCount":4},"100650472","non-invasive-triage-for-intracranial-hypertension-in-prehospital-care-100650472","NCT07747636","Non-Invasive Triage for Intracranial Hypertension in Prehospital Care","Implementation of Non-Invasive Triage for Intracranial Hypertension Assessment in Prehospital Care","B4C-APH","Inclusion Criteria:\n\n* Age 18 years or older\n* Attended by the Mobile Emergency Care Service (SAMU) in the metropolitan area of Salvador, Brazil\n* Clinical presentation suggestive of acute stroke (sudden focal neurological deficit or sudden and severe headache) OR moderate\u002Fsevere traumatic brain injury (Glasgow Coma Scale)\n\nExclusion Criteria:\n\n* Individuals with brain injuries of other etiologies, such as prior traumatic brain injury (TBI) and\u002For stroke, neoplasms, infections, sepsis, arteriovenous malformation, intoxication, and illicit drug use;\n* Individuals with scalp and\u002For skin lacerations that prevent positioning of the brain4care sensor;\n* Individuals with craniectomy;\n* Severe debilitating mental health disorders and\u002For severe debilitating neurological diseases;\n* Agitated, aggressive, or uncooperative individuals whose condition prevents follow-up and outcome assessment;\n* Pregnant women.",{"count":428,"type":21},180,[51],"This study tests whether two non-invasive tools can help paramedics detect dangerously high pressure inside the skull in patients with a sudden brain injury, such as stroke or head trauma, before they reach the hospital.\n\nThe tools are a wearable sensor called Brain4care, placed on the head, and an ultrasound measurement of the eye's optic nerve. Neither tool requires needles, incisions, or any invasive procedure.\n\nThe study has two parts. In the first part, researchers will use both tools on patients treated by the Mobile Emergency Care Service (SAMU) in Salvador, Brazil, to check how accurately the tools can detect high pressure inside the skull. The results from these tools will not be used to guide the patient's care during this part of the study.\n\nIn the second part, some patients will be assessed using these tools as part of their emergency care, while other patients will receive standard emergency care. Researchers will compare how often each group of patients is correctly sent to a hospital with the specialized brain surgery services they may need.\n\nThe goal of this research is to help emergency teams identify patients with dangerous brain pressure earlier and get them to the right hospital faster, which may improve their chances of recovery.",[432,129,102,25,433],"Intracranial Hypertension","Subarachnoid Hemorrhage",[435,436,437,438,439,440,441],"Non-invasive intracranial pressure monitoring","Brain4care","Optic nerve sheath diameter","Prehospital triage","Emergency medical services","Neurocritical care","Intracranial pressure waveform","2026-07-31",{"date":444,"type":30},"2026-08-05",{"date":446,"type":21},"2026-09-01",{"date":448,"type":21},"2027-03",{"name":450,"class":66},"Juliana Caldas",{"id":452,"slug":453,"hasResults":12,"nctId":454,"briefTitle":455,"officialTitle":456,"acronym":4,"eligibilityCriteria":457,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":373,"enrollmentInfo":458,"targetDuration":4,"studyType":49,"phases":459,"briefSummary":460,"conditions":461,"keywords":465,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":470,"lastUpdatePostDateStruct":471,"startDateStruct":472,"completionDateStruct":474,"leadSponsor":476,"locationsCount":114},"100649757","zepu-sgi1plus-hand-training-study-zepusgi1rct-100649757","NCT07739264","ZEPU-SGI1PLUS Hand Training Study (ZEPUSGI1RCT)","Feasibility, Safety and Efficacy of ZEPU-SGI1PLUS Hand Functional Comprehensive Training Systems in Patients With Upper Limb Motor Dysfunction","Inclusion Criteria:\n\n* Presence of upper-limb motor dysfunction, with or without concurrent lower-limb impairment, due to one of the following conditions: (a) stroke, with onset between 2 and 24 months prior to enrollment; (b) incomplete spinal cord injury (neurological level C5 and below), classified as ASIA Impairment Scale C or D; (c) traumatic brain injury with persistent upper-limb functional limitation; or (d) orthopedic or post-surgical conditions involving the shoulder, elbow, wrist, or hand with persistent functional impairment for \\> 3 months\n* Age between 18 and 60 years, inclusive\n* Ability to understand study procedures and follow instructions, and to provide written informed consent (or assent with guardian consent where applicable)\n* Body weight and limb anthropometry compatible with the ZEPU-SG1PLUS Hand Functional Comprehensive Training System per manufacturer specifications\n* Medically stable and cleared by a physician for robotic rehabilitation, with no active infection, uncontrolled cardiac or respiratory disease, severe osteoporosis, uncontrolled epilepsy, or untreated deep vein thrombosis\n\nExclusion Criteria:\n\n* Complete spinal cord injury or profound motor paralysis preventing safe interaction with robotic devices\n* Severe cognitive impairment, defined as a Mini-Mental State Examination (MMSE) score \\\u003C 24, that would compromise safe participation\n* Severe spasticity of the upper limb, defined as a Modified Ashworth Scale score \\> 3\n* Unstable fractures, severe fixed joint contractures of the shoulder, elbow, wrist, or hand (e.g., \\> 30°), or severe pain limiting safe robotic training\n* Uncontrolled cardiac arrhythmia, presence of a pacemaker, or other implanted electronic medical device incompatible with robotic sensors\n* Pregnancy",{"count":375,"type":21},[51],"The goal of this pilot randomized controlled trial is to learn whether the ZEPU-SG1PLUS Hand Functional Comprehensive Training System - a robotic device used alongside standard rehabilitation - is safe, feasible, and helpful for people with upper limb (arm\u002Fhand) motor problems caused by stroke, incomplete spinal cord injury, traumatic brain injury, or orthopedic conditions.\n\nThe main questions it aims to answer are:\n\nIs robotic-assisted hand training well tolerated by patients, and can it be safely added to standard rehabilitation, with acceptable rates of device-related side effects? Does adding robotic hand training to standard rehabilitation improve arm and hand strength, range of motion, and functional ability compared with standard rehabilitation alone? Is it practical to fit this type of robotic training into everyday rehabilitation services at Bangladesh Medical University?\n\nResearchers will compare a robotic-augmented rehabilitation group to a standard-care (control) group to see whether adding robotic hand training works better than usual rehabilitation alone.\n\nParticipants will:\n\nBe randomly assigned to one of two groups: one receiving standard rehabilitation plus robotic hand training with the ZEPU-SG1PLUS device, and one receiving standard rehabilitation alone If assigned to the robotic training group, attend three training sessions per week for 12 weeks, each lasting about 30-45 minutes, at the Robotic Rehabilitation Centre, BMU Undergo assessments at the start of the study and at two-week intervals during the 12-week program and follow-up period, including tests of muscle strength, joint movement, hand function, and daily activity ability Be monitored throughout for any side effects or safety concerns related to the training",[462,102,463,25,464],"Upper Limb Motor Dysfunction","Incomplete Spinal Cord Injury","Upper Limb Orthopedic Trauma",[466,467,468,214,469],"Robotic Rehabilitation","ZEPU-SG1PLUS","Hand Function Training","Musculoskeletal Rehabilitation","2026-07-29",{"date":442,"type":30},{"date":473,"type":21},"2026-07",{"date":475,"type":21},"2026-11",{"name":395,"class":66},{"id":478,"slug":479,"hasResults":12,"nctId":480,"briefTitle":481,"officialTitle":482,"acronym":4,"eligibilityCriteria":483,"healthyVolunteers":12,"sex":17,"minAge":484,"maxAge":124,"enrollmentInfo":485,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":486,"conditions":487,"keywords":492,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":470,"lastUpdatePostDateStruct":504,"startDateStruct":506,"completionDateStruct":507,"leadSponsor":509,"locationsCount":114},"100637740","brain-blood-flow-and-cerebral-autoregulation-monitoring-in-critically-ill-children-100637740","NCT07613918","Brain Blood Flow and Cerebral Autoregulation Monitoring in Critically Ill Children","Transcranial Doppler Assessment of Cerebral Autoregulation and Blood Flow Velocity Patterns in Critically Ill Children: A Prospective Observational Study","Inclusion Criteria:\n\n* Has at least one Parent or Legal Guardian who is willing and able to provide informed consent in English\n* Mechanically ventilated (Endotracheal tube)\n* Indwelling arterial catheter\n* Current patient in the American Family Children's Hospital PICU.\n* 1 day to 17.5 years of age\n\nExclusion Criteria:\n\n* Subjects with a known or obvious anatomic barrier preventing safe application of the transcranial Doppler probe (e.g., cranial dressings, cranial fixation hardware, ventricular access devices positioned over insonation sites, or bilateral craniectomies)\n* Patient with known chronic hypertension\n* Admission FSS score \\> 16\n* Tracheostomized patient\n* The designated sub-investigator (Dr. Talal Al Hendawi) and PI (Dr. Neil Munjal) are unavailable to perform the Transcranial Doppler scan at the time of eligibility. All study scans are performed by either Dr. Al Hendawi or Dr.Munjal to ensure standardization and data integrity. Therefore, if they are unavailable (e.g., due to clinical service, leave, or other scheduling constraints), the patient will not be enrolled in the study.\n* Not suitable for study participation due to other reasons at the discretion of the investigators","1 Day",{"count":183,"type":21},"This study uses a non-invasive (external) ultrasound test called Transcranial Doppler (TCD) to measure how blood flows through the major arteries of the brain of children receiving care in the Pediatric Intensive Care Unit (PICU). TCD is already used for clinical reasons in many children, but it is not part of routine monitoring for every critically ill child. By using TCD, the investigators hope to better understand how brain blood flow changes during illness. They will also track children's functional status from before their illness to the time of PICU discharge to explore how brain blood flow patterns relate to neurological outcomes.125 participants will be enrolled and will be on study while in the PICU, estimated to be 3-14 days.",[488,489,490,25,491],"Critical Illness","Pediatric Critical Illness","Respiratory Failure","Cardiac Arrest",[493,494,495,496,497,498,499,144,500,501,502,503],"PICU","infant","Transcranial Doppler Assessment","Cerebral Autoregulation","Blood Flow Velocity","children","mechanical ventilation","pulsatility index","Mean flow index","neonate","pediatric critical care",{"date":505,"type":30},"2026-07-30",{"date":170,"type":21},{"date":508,"type":21},"2028-05",{"name":510,"class":66},"University of Wisconsin, Madison",{"id":512,"slug":513,"hasResults":12,"nctId":514,"briefTitle":515,"officialTitle":516,"acronym":4,"eligibilityCriteria":517,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":518,"enrollmentInfo":519,"targetDuration":4,"studyType":49,"phases":521,"briefSummary":522,"conditions":523,"keywords":4,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":524,"lastUpdatePostDateStruct":525,"startDateStruct":527,"completionDateStruct":528,"leadSponsor":530,"locationsCount":4},"100650049","self-management-training-among-individuals-with-tbi-100650049","NCT07741149","Self-Management Training Among Individuals With TBI","Chronic Disease Self-Management Among Individuals With TBI","Inclusion Criteria:\n\n* Aged ≥18 years at time of first TBI\n* At least one year since the most recent TBI\n* Received care at BMC's Concussion\u002FTBI program for a TBI or concussion\n* At least partially involved in Self-care\n* Able to provide consent\n* Able to speak and understand English\n* Available for study duration.\n\nExclusion Criteria:\n\n* • Aged \\\u003C18 at the time of their first TBI\n\n  * Severe mental, cognitive, social, or emotional difficulties due to another neurologic, developmental, psychological condition, or active substance use disorder\n  * Participating in another interventional clinical trial\n  * Planned major surgery in the next 4 months.\n  * Pregnancy (self-report).\n  * Suspected or known drugs or alcohol abuse\n  * Endorses suicidal ideation\n  * All individuals with reduced decision-making capacity, an assigned LAR, or conservator.","100 Years",{"count":520,"type":21},85,[51],"Traumatic brain injury (TBI) can have long-term and chronic effects on an individual's physical, social, and emotional health, impacting quality of life and the ability to engage in meaningful life roles. Despite the potential for long-term effects, much of the care for individuals with TBI is front-loaded in the weeks to months post-injury. Self-management and self-management training are key components of long-term care for many chronic health conditions, but they are not standard parts of care for individuals with TBI.\n\nIn this study the investigators will address two objectives: 1) identify self-management priorities from the perspectives of individuals with chronic TBI, families, and health care providers and 2) pilot test an existing virtual community-based self-management training program (the Chronic Disease Self-Management Program (CDMSP)), to a) evaluate changes in quality of life, self-management self-efficacy, and other patient-reported outcomes before and after participating in the training, and b) identify barriers and facilitators to participating in community-based self-management training.",[25],"2026-07-27",{"date":526,"type":30},"2026-08-03",{"date":337,"type":21},{"date":529,"type":21},"2029-03",{"name":531,"class":66},"Boston University Charles River Campus",{"id":533,"slug":534,"hasResults":12,"nctId":535,"briefTitle":536,"officialTitle":537,"acronym":4,"eligibilityCriteria":538,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":539,"targetDuration":4,"studyType":49,"phases":541,"briefSummary":542,"conditions":543,"keywords":546,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":554,"lastUpdatePostDateStruct":555,"startDateStruct":557,"completionDateStruct":559,"leadSponsor":561,"locationsCount":114},"100649203","phase-2-long-term-outcomes-following-hbot-100649203","NCT07732374","Long-Term Outcomes Following HBOT","Assessing Follow-Up Effects Post-Discontinuation of Hyperbaric Oxygen Therapy on Cognitive Function, Mental Health, and Quality of Life in Veterans","Inclusion Criteria:\n\n1. At least 18 years of age.\n2. Veteran status\n3. Clinically diagnosed with a mTBI, PCS, PTSD, Anxiety, or Depression disorder.\n4. Successfully completed the parent Hyperbaric Oxygen Therapy (HBOT) intervention, consisting of the full study treatment protocol (40 HBOT sessions).\n5. Willing and able to read, understand, and provide written informed consent for participation in the 12-week follow-up study. Additionally, the Participant has clear consciousness and the ability to express self-feelings independently.\n6. Completed cognitive and psychological measurements.\n7. Clinical diagnoses cause significant impairment in social or occupational functioning or some other functional capacity.\n8. Stability on any current psychoactive medications (antidepressants, anti-anxiety medications, antipsychotics, stimulants, and mood stabilizers).\n\nExclusion Criteria:\n\n1. Acute medical illness or infection\n2. Severe or unstable physical disorders or major cognitive deficits\n3. Current manic, psychotic episodes, or serious suicidal ideations\n4. Non-English speakers\n5. Inability to attend scheduled follow-up visits\n6. Significant life events, new neurological injury, or new psychiatric diagnosis or hospitalization occurring after completion of the HBOT intervention that, in the opinion of the investigator, could confound cognitive, psychological, or quality-of-life outcomes.\n7. Participation in another interventional clinical study or receipt of a therapeutic intervention following completion of HBOT that could influence cognitive, psychological, or quality-of-life outcomes.",{"count":540,"type":21},35,[234],"This study is designed to better understand the long-term effects of hyperbaric oxygen therapy (HBOT). Our goal is to determine whether improvements after treatment are maintained over time and whether additional benefits appear months after treatment has ended. We will evaluate changes in cognitive function, mental health, and daily functioning to help strengthen the scientific evidence supporting the use of HBOT and guide future treatment recommendations.",[25,544,545],"Post-Concussive Symptoms","Post-Traumatic Stress Disorder",[547,548,549,550,551,552,25,553],"Hyperbaric Oxygen Therapy","Treatment Durability","Cognitive Function","Mental Health","Quality of Life","Veterans","Persistent Post-Concussive Symptoms (PCS)","2026-07-23",{"date":556,"type":30},"2026-07-28",{"date":558,"type":30},"2026-06-18",{"date":560,"type":21},"2027-06-18",{"name":562,"class":66},"Summit Hyperbarics and Wellness",{"id":564,"slug":565,"hasResults":12,"nctId":566,"briefTitle":567,"officialTitle":568,"acronym":569,"eligibilityCriteria":570,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":252,"enrollmentInfo":571,"targetDuration":572,"studyType":22,"phases":4,"briefSummary":573,"conditions":574,"keywords":577,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":582,"lastUpdatePostDateStruct":583,"startDateStruct":584,"completionDateStruct":585,"leadSponsor":587,"locationsCount":114},"100648597","onsd-trajectory-in-rebound-ich-100648597","NCT07722702","ONSD Trajectory in Rebound ICH","Optic Nerve Sheath Diameter Trajectory During Osmotherapy Weaning as a Predictor of Rebound Intracranial Hypertension in Traumatic Brain Injury","ONSD\u002F INH","Inclusion Criteria:\n\n* Adults (≥18 years) with blunt traumatic brain injury admission GCS ≤12\n* (or GCS 13-15 with CT signs of elevated ICP including midline shift ≥5 mm, effaced cisterns, or significant cerebral edema)\n* clinical decision to initiate 20% mannitol osmotherapy\n\nExclusion Criteria:\n\n* Ocular conditions precluding ONSD measurement (glaucoma, prior ocular surgery,\n* globe or optic nerve trauma,\n* periorbital edema, orbital masses, optic nerve sheath cysts);\n* planned decompressive surgery or evacuation of mass lesion within 48 hours; limitation of life-sustaining therapy; pregnancy; contraindications to mannitol (baseline sodium \\>155 mEq\u002FL, osmolality \\>320 mOsm\u002Fkg, eGFR \\\u003C30 mL\u002Fmin); penetrating TBI; or concurrent spinal cord injury with shock.",{"count":77,"type":21},"6 Weeks","The goal of this prospective observational study is to determine whether the trajectory of optic nerve sheath diameter (ONSD) after osmotherapy weaning can predict rebound intracranial hypertension in adult patients with traumatic brain injury requiring osmotherapy for elevated intracranial pressure. The main questions it aims to answer are:\n\nDoes the trajectory of ONSD during osmotherapy weaning predict the development of rebound intracranial hypertension? What is the diagnostic accuracy of serial ONSD measurements for the early detection of rebound intracranial hypertension? Researchers will compare patients who develop rebound intracranial hypertension with those who do not to determine whether changes in ONSD trajectory differ significantly between the two groups.\n\nParticipants will:\n\nUndergo serial bedside ocular ultrasound examinations for ONSD measurement at predefined time points after osmotherapy weaning.\n\nReceive standard clinical management for traumatic brain injury according to institutional protocols; no additional therapeutic intervention will be administered.\n\nUndergo routine neurological assessments, laboratory investigations, and neuroimaging as clinically indicated.\n\nBe followed for the occurrence of rebound intracranial hypertension and relevant clinical outcomes during their ICU stay",[25,575,576],"Rebound Intracranial Hypertension","Cerebral Edema",[578,579,580,581],"ONSD","Osmotherapy","Rebound ICH","Cerebral edema","2026-07-19",{"date":554,"type":30},{"date":446,"type":21},{"date":586,"type":21},"2027-10-01",{"name":588,"class":66},"Benha University",{"id":590,"slug":591,"hasResults":12,"nctId":592,"briefTitle":593,"officialTitle":594,"acronym":4,"eligibilityCriteria":595,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":596,"targetDuration":4,"studyType":49,"phases":598,"briefSummary":599,"conditions":600,"keywords":604,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":611,"lastUpdatePostDateStruct":612,"startDateStruct":614,"completionDateStruct":616,"leadSponsor":618,"locationsCount":114},"100648390","vagus-nerve-stimulation-in-patients-in-comatose-state-100648390","NCT07719595","Vagus Nerve Stimulation in Patients in Comatose State","Dual-Site Transcutaneous Auricular Nerve Stimulation (taVNS + taTNS) for Disorders of Consciousness After Traumatic Brain Injury: A Pilot Efficacy Study","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Coma, vegetative state\u002Funresponsive wakefulness syndrome (VS\u002FUWS), or minimally conscious state (MCS) as determined by baseline CRS-R\n* Acute traumatic brain injury with documented intracranial pathology on neuroimaging\n* Admission to the Neurology or Neurosurgical ICU\n* Legally authorized representative (LAR) available and willing to consent, including the Stimulation Addendum Consent Form\n\nExclusion Criteria:\n\n* Implanted cardiac pacemaker, vagus nerve stimulator, or other active implanted device\n* Known cardiac arrhythmia (e.g., 2nd-\u002F3rd-degree AV block, atrial fibrillation with uncontrolled rate)\n* Active seizures not controlled by current antiepileptic regimen\n* Skin breakdown, infection, or anatomical abnormality of the left ear precluding electrode placement\n* Pregnancy\n* Hemodynamic instability requiring vasopressor escalation at the time of enrollment",{"count":597,"type":21},10,[51],"Some patients with severe traumatic brain injury cannot respond at the bedside, yet about 1 in 4 may be aware but unable to show it - a hidden state called cognitive motor dissociation. This study tests a gentle, non-invasive treatment delivered through clips on the left ear that stimulates two nerves at once: the vagus nerve at the inner ear (taVNS) and the trigeminal nerve at the outer ear (taTNS). Each nerve has separately been shown to help people with disorders of consciousness recover, but they have not been combined before. All enrolled patients receive the stimulation for one hour a day, with continuous heart and oxygen monitoring and a pain-protection check used to keep the dose safe. The study measures recovery two ways: the Coma Recovery Scale-Revised (CRS-R), scored by clinicians, and SeeMe, an automated camera system that detects tiny command-driven movements the eye cannot see.",[25,601,602,603],"Severe Traumatic Brain Injury","Disorders of Consciousness Due to Severe Brain Injury","Coma, Traumatic",[605,606,607,608,609,610],"taVNS","taTNS","transcutaneous auricular vagus nerve stimulation","trigeminal nerve stimulation","dual-site neuromodulation","coma","2026-07-17",{"date":613,"type":30},"2026-07-22",{"date":615,"type":30},"2026-06-26",{"date":617,"type":21},"2029-12",{"name":619,"class":66},"Sima Mofakham",{"id":621,"slug":622,"hasResults":12,"nctId":623,"briefTitle":624,"officialTitle":625,"acronym":626,"eligibilityCriteria":627,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":296,"enrollmentInfo":628,"targetDuration":4,"studyType":49,"phases":630,"briefSummary":631,"conditions":632,"keywords":633,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":636,"lastUpdatePostDateStruct":637,"startDateStruct":638,"completionDateStruct":639,"leadSponsor":640,"locationsCount":315},"100632160","modulating-inflammation-in-neuro-trauma-100632160","NCT07510074","Modulating Inflammation in Neuro-Trauma","MINT: Modulating Inflammation in Neuro-Trauma","MINT","Inclusion Criteria:\n\n* Age 18-75 years old\n* Glasgow Coma Scale (GCS) Score 3-12\n* Expected Intensive Care Unit (ICU) stay \\> 48 hours\n* Presenting with acute Traumatic Brain Injury (TBI) within 24 hours\n\nExclusion Criteria:\n\n* Pregnant\n* Any electrical implanted device\n* Immunomodulatory medication\n* Human Immune Deficiency Virus (HIV) patients\n* Autoimmune disease\n* Known cancer immunotherapy\n* Past medical history of symptomatic bradycardia\n* Penetrating brain injury\n* Clinical team assessment of prognosis and imminent risk of death such as Decision to withdraw life-sustaining measures\n* Current incarceration\n* Trauma\u002FLaceration to the left ear",{"count":629,"type":21},16,[51],"MINT is a single-site, prospective, randomized, double-blind, sham-controlled pilot trial evaluating the safety and feasibility of transcutaneous auricular vagus nerve stimulation (taVNS) in patients with moderate to severe traumatic brain injury (GCS 3-12). Participants will be randomized to receive either active taVNS or sham stimulation using the same device. The primary objective is to assess the safety and feasibility of taVNS implementation in the acute TBI setting. Secondary objectives include exploratory measurement of serum inflammatory and neuronal injury biomarkers and assessment of functional outcome using the Extended Glasgow Outcome Scale at hospital discharge.",[25],[634,635,581],"Vagus nerve stimulation (VNS)","Inflammation","2026-07-15",{"date":611,"type":30},{"date":170,"type":21},{"date":448,"type":21},{"name":641,"class":66},"The University of Texas Health Science Center at San Antonio",{"id":643,"slug":644,"hasResults":12,"nctId":645,"briefTitle":646,"officialTitle":646,"acronym":4,"eligibilityCriteria":647,"healthyVolunteers":12,"sex":17,"minAge":648,"maxAge":649,"enrollmentInfo":650,"targetDuration":4,"studyType":49,"phases":651,"briefSummary":652,"conditions":653,"keywords":654,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":636,"lastUpdatePostDateStruct":658,"startDateStruct":659,"completionDateStruct":661,"leadSponsor":663,"locationsCount":114},"100551838","promoting-neuroplastic-changes-of-patients-with-tbi-100551838","NCT06465290","Promoting Neuroplastic Changes of Patients With TBI","Inclusion Criteria:\n\n* Acute first time unilateral hemispheric stroke (hemorrhagic or ischemic stroke, 24 hours after admission to 1 month post-stroke at the start of the proposed treatment)\n* Hemiplegia or hemiparesis\n* 0≤Manual Muscle Testing (MMT)\\\u003C=2\n* Age 30-85\n* Ankle impairments including stiff calf muscles and\u002For inadequate dorsiflexion\n\nExclusion Criteria:\n\n* Medically not stable\n* Associated acute medical illness that interferes with ability to training and exercise\n* No impairment or very mild ankle impairment of ankle\n* Severe cardiovascular problems that interfere with ability to perform moderate movement exercises\n* Cognitive impairment or aphasia with inability to follow instructions\n* Severe pain in legs\n* Severe ankle contracture greater than 15° plantar flexion (when pushing ankle to dorsiflexion)\n* Pressure ulcer, recent surgical incision or active skin disease with open wounds present below knee","30 Years","85 Years",{"count":77,"type":21},[51],"This project will develop a wearable rehabilitation robot suitable for in-bed acute stage rehabilitation. It involves robot-guided motor relearning, passive and active motor-sensory rehabilitation early in the acute stage post-TBI including patients who are paralyzed with no motor output. The early acute TBI rehabilitation device will be evaluated in this clinical trial.",[25],[655,656,657],"Traumatic Brain Injury (TBI)","Paraplegia","Acute",{"date":611,"type":30},{"date":660,"type":30},"2026-07-16",{"date":662,"type":21},"2030-08-31",{"name":664,"class":66},"University of Maryland, Baltimore"]