Brain Injury

A study examining the effects of creatine supplementation to improve recovery after brain injury in children and teenagers.

Prolonged disorders of consciousness (pDOC) are defined as DOC lasting \>1 year post injury for patients with Traumatic Brain Injury (TBI) and \>3 months post injury for patients with non-TBI and at present there are limited treatments that reliably lead to enhanced prognosis. The rehabilitation process throughout the continuum of care for patients with pDOC necessitates restorative strategies to facilitate arousal and functional recovery and coordinated medical management. Rehabilitation interventions for patients with DOC and pDOC have evolved in the past decade, with an emerging body of evidence highlighting the benefits of rehabilitation intervention even in the acute. While there is data to support the individual utility of these modalities, no work to date has investigated the benefits of pairing transauricular vagus nerve stimulation (taVNS) and robotic tilt table mobilization (RTTM) to maximize functional recovery in patients with pDOC. This study will report on the safety, feasibility, and preliminary short- and long-term outcomes of RTTM with simultaneously paired Transcutaneous auricular vagus nerve stimulation (taVNS) for Severe Acquired Brain Injury (SABI) patients with pDOC . Fifteen (15) participants will be recruited and complete a 12-week rehabilitation protocol using paired taVNS and RTTM. Once participants have been screened and enrolled in the study, they will complete three study phases: T1: a baseline observation of standard of care T2, intervention, and T3 longitudinal follow up.

The goal of this observational study is to learn whether functional near-infrared spectroscopy (fNIRS) can measure brain activity in healthy adults and in people with disorders of consciousness (DoC) in the neuro-intensive care unit (Neuro-ICU). DoC include conditions such as coma and minimally conscious state that occur after severe brain injury. These conditions make it difficult to assess a person's level of awareness because many clinical tests rely on observable behaviors such as speaking or moving, which are commonly impaired after brain injury. The main questions the study aims to answer are: * Can fNIRS detect changes in brain activity in healthy adults when they receive sensory stimulation or perform mental tasks? * Can the same fNIRS protocol be used in patients with disorders of consciousness in the Neuro-ICU to measure brain responses and determine whether the method is feasible in this clinical setting? The investigators will first study healthy adult volunteers to establish baseline brain responses and determine which tasks produce the most reliable signals. The protocol will then be applied to patients with disorders of consciousness admitted to the Neuro-ICU. Participants will take part in a single research session lasting about 30 to 45 minutes while wearing the lightweight fNIRS headband that measures brain oxygen levels using near-infrared light. During the session, participants will: * Wear a non-invasive fNIRS headband placed on the forehead * Receive gentle sensory stimulation (for example, compression devices on the legs or hands) * Listen to sounds or spoken sentences * Perform guided mental tasks such as imagining walking through their home or imagining moving a limb The study does not test a treatment and will not change medical care. The goal is to determine whether fNIRS can safely and reliably measure brain activity at the bedside and provide preliminary information that may help guide future research on improving the assessment of consciousness after brain injury.

This expanded access protocol is part of IND 031942 to evaluate efficacy and safety of multiple intravenous administrations of allogeneic HB-adMSCs for the treatment of nontraumatic or traumatic brain injury for up to 8 patients who passed pre-screening, completed screening, and were not randomized into the treatment group for the HBBI01 clinical study protocol entitled, "An Intermediate Size Patient Population Expanded Access Protocol to Evaluate the Safety and Efficacy of Allogeneic HB-adMSCs for the Treatment of Patients with Traumatic or Nontraumatic Brain Injury." under IND 027396.

Postoperative pain is prevalent after intracranial surgery. Patients undergoing craniotomy are typically managed with short acting opioids to enable early and reliable post-operative neurological exam as well as avoid the risk of respiratory depression. However, a plethora of studies have shown that a majority of these patients experience moderate to severe pain in first 48 hours after surgery. Suboptimal pain control can lead to complications such as arterial hypertension and post-operative intracranial hemorrhage, and hence, increased morbidity and mortality. Intravenous (IV) methadone has a long analgesic half-life and has N-methyl-D-aspartate (NMDA) receptor antagonist and serotonin and norepinephrine reuptake inhibitor (SNRI) properties. It has previously been shown to reduce postoperative opioid requirements, postoperative nausea and vomiting (PONV), and postoperative pain scores in patients that underwent orthopedic, abdominal, complex spine, and cardiac surgery. Similar findings have been shown in obstetric patients that underwent caesarean delivery under general anesthesia as well as patients that underwent gynecologic surgery and received IV methadone intraoperatively. In a recently published retrospective study, a single intraoperative dose of IV methadone was well tolerated with lower pain scores as well as MME (oral morphine milligram equivalents) requirements for up to 72 hours after elective intracranial surgery. IV methadone has, however, never been compared with conventional management via IV remifentanil for functional recovery in patients undergoing elective intercranial surgery. The investigator's hypothesis is that intravenous (IV) methadone is non-inferior to IV remifentanil in patients who undergo elective intracranial surgery. It offers the advantage of being a single dose noninvasive analgesic modality that may contribute to decreasing MME consumption during the first 72 hours postoperatively, controlling postoperative pain, and improving quality of recovery after surgery.

Patients born with heart defects often undergo surgical procedures on a heart lung machine. With improvements in medical and surgical management, their survival has significantly improved, but their brain insult has not been paid much attention. This study is to determine the relationship between specific proteins in the blood and brain injury in patients less than 18-year-old undergoing heart surgery.

The purpose of this research study is to determine whether COMA-F is more efficacious at reducing emotional distress in caregivers of patients with severe acute brain injuries, compared to health education control.

Acquired brain injuries (ABIs) frequently cause emotional and behavioral disorders that impair independence and quality of life, particularly in institutions. Virtual reality (VR), already used in various mental and neurological disorders, offers therapeutic potential that remains largely unexplored in this context. Multisensory devices offer enhanced immersion that can potentially increase the relaxation and calming effect. Their use in specialized care home (SCH) could provide additional support for care. The main objective of the study is to measure the effect of an 8-week multisensory VR relaxation program on the most significant emotional and behavioral disorders in adults with acquired brain injury living in SCH. The SCED method with multiple baselines across subjects (ABA) is used with three adult residents with ABCI and behavioral disorders living in SCH. The study consists of three phases (baseline, intervention, follow-up), during which the three main emotional and behavioral disorders of each resident are assessed weekly based on observations made throughout the week. Additional measures include the assessment of the socio-emotional profile by the care team (ECCSEG) and the emotional distress experienced by residents (QOLIBRI), collected twice per phase. The intervention consists of eight weeks of VR relaxation (VirtySens®), with two 15-minute sessions per week. All measurements taken during the experiment will be anonymized and used only by the investigators, who are fully aware of the European GDPR (General Data Protection Regulation) concerning the protection of personal data.

In high-income countries, coronary artery bypass grafting (CABG) remains a common procedure, with approximately 36.7 operations per 100,000 inhabitants annually, corresponding to about 136,000 procedures in the European Union. This highlights the substantial healthcare burden and the need to optimize surgical outcomes. Cardiopulmonary bypass (CPB) is a fundamental component of cardiac surgery, ensuring extracorporeal perfusion of vital organs. Hypothermic CPB has historically been widely used for organ protection due to its presumed neuroprotective mechanisms. However, evidence demonstrating its superiority over normothermic CPB remains inconclusive. In its 2024 guidelines, the European Association for Cardio-Thoracic Surgery recommends considering normothermia (≥35 °C) to reduce postoperative neurocognitive dysfunction (Class II, Level A). This recommendation is primarily based on two meta-analyses, but the underlying studies show methodological heterogeneity, outdated practices, and limited applicability to contemporary cardiac surgery. Importantly, the guidelines acknowledge the need for large randomized controlled trials to define optimal target temperature management (TTM) during CPB. Previous diffusion-weighted MRI studies have demonstrated silent ischemic brain lesions in approximately 30% of CABG patients, with postoperative neurocognitive decline occurring in a similar proportion. However, no significant differences have been shown between normothermic and hypothermic CPB. Diffusion tensor imaging (DTI) extends conventional diffusion imaging by enabling detailed assessment of white matter microstructure and tractography. Fractional anisotropy (FA), a key DTI metric, has demonstrated prognostic value in various neurological conditions but has not yet been applied in CABG patients. Blood-based biomarkers, including glial fibrillary acidic protein, neurofilament light chain, neuron-specific enolase, and total tau, offer complementary insights into brain injury but have not been studied in combination with DTI in this population. This study will compare mild hypothermic (33-34 °C) and normothermic (36.5 °C) CPB to evaluate their neuroprotective effects using advanced MRI techniques and blood-based biomarkers. The primary aim is to determine whether mild hypothermia provides superior neuroprotection following CABG. Secondary objectives include assessing white matter injury evolution, global ischemic burden, associations with biomarkers and neurocognitive decline, and developing integrated prognostic models to improve outcomes in CABG patients.

The MIRROR study will compare the effectiveness of two interventions in improving emotion regulation and reducing PTSD symptoms in female Veterans with military sexual trauma (MST) and/or intimate partner violence (IPV) and co-occurring brain injury.

Veterans with mild traumatic brain injury (mTBI) and post-traumatic stress disorder (PTSD) commonly experience cognitive impairments including attention and executive function deficits that interfere with their ability to engage in productive personal and social activities. Of the limited interventions available to address cognition, none rigorously train attention beyond strategy management. This study will evaluate an innovatively combined strategy training known as Goal Management Training plus computerized attention training in Veterans with mTBI/PTSD. Preliminary testing suggests an effectiveness in improving problem solving, attention and functional tasks in a small number of Veterans. Considering these promising results, cost effectiveness, and the demand for access to care from Veterans living in rural areas, a Randomized Controlled Trial will determine and compare the effects of this treatment, administered either in-person or via telehealth, on executive function, attention, other aspects of cognition and real life functional tasks.

Evaluate the effectiveness of the Q Therapeutic (BQ 3.0) System for individuals with chronic stroke in improving upper extremity function as determined by change in functional outcome measures after 3-month treatment, including in-clinic and at-home sessions.

This is a prospective intervention single center study to evaluate the feasibility and safety of intranasal breast milk in hypoxic-ischaemic encephalopathic neonates receiving therapeutic hypothermia.

Patients with brain injury secondary to stroke, surgery, or trauma frequently suffer from homonymous hemianopia, defined as vision loss in one hemifield secondary to retro- chiasmal lesion. Classic and effective saccadic compensatory training therapies are current aim to reorganize the control of visual information processing and eye movements or, in other words, to induce or improve oculomotor adaptation to visual field loss. Patients learn to intentionally shift their eyes and, thus, their visual field border, into the area corresponding to their blind visual field. This shift brings the visual information from the blind hemifield into the seeing hemifield for further processing. Patients learn, therefore, to efficiently use their eyes "to keep the 'blind side' in sight". Biofeedback training (BT) is the latest and newest technique for oculomotor control training in cases with low vision when using available modules in the new microperimetry instruments. Studies in the literature highlighted positive benefits from using BT in a variety of central vision loss, nystagmus cases, and others.The purpose of this study is to assess systematically the impact of BT in a series of cases with hemianopia and formulate guidelines for further use of this intervention in vision rehabilitation of hemianopia cases in general.

Colorectal cancer (CRC), with annually increasing incidence and mortality worldwide, has become the second leading cause of cancer-related death. The development of CRC often follows the canonical normal-adenoma-carcinoma (N-A-C) sequence driven by progressive accumulation of molecular genetic events, highlighting the importance of early detection and removal of precancerous lesions. However, some patients who have had adenomas removed still have a high risk of developing new adenomas or CRC, especially for those with chronic or systemic disease, indicating that a compositive regulatory network is involved in the tumorigenesis of CRC. Additionally, despite advances in therapeutic strategies having improved the prognosis of CRC patients, tumor metastasis continues to be the predominant cause of mortality. These suggest the need to transcend limitations focusing solely on intertumoral microenvironment or single-timepoint event but adopt a more systemic perspective to elucidate the mechanisms underlying the whole sequence of CRC development and progression. The gastrointestinal (GI) tract comprises a complex ecosystem with extensive interactions between normal or neoplastic epithelial cells with immune, neuronal, and other cell types, as well as microorganisms and metabolites within the gut lumen. Specifically, the intricate relationship between the GI tract and the central nervous system (CNS), collectively known as the brain-gut axis, plays a pivotal role in the pathogenesis of gastrointestinal disorders and neoplasm. For instance, chronic stress increased the risk of colon cancer via activating the COX-2/PEG2 system and promoted tumor cell dissemination by remodeling lymph vasculature. The bidirectional communications of the brain-gut axis are generally found to be mediated by neurotransmitters, inflammatory cytokines, metabolites, or gut microbiota. Nonetheless, the spotlight has shone primarily on the brain-gut crosstalk mechanisms in experimental cellular or animal models, with less attention paid to the structural and functional alterations on the brain networks at the patient level. The evolution of functional neuroimaging modalities and neuroscience technologies has enabled accurate delineation of CNS activities. Specifically, nuclear medicine imaging technology using 2-18F fluoro-2-deoxy-D-glucose (18F-FDG) to adopt whole-body imaging information, is the optimal in vivo method for the investigation of regional human brain metabolism and associations with systemic disorders. We have previously identified the neuronal metabolic-ventricular dyssynchronization axis which might related to major arrhythmic events using myocardial perfusion imaging and the brain 18F-FDG positron emission tomography (PET). Given the potential dual interactions of the brain-gut axis, identification of specific brain regions associated with CRC development and progression might lead to a better understanding of the disease's neurobiological underpinnings and inform the development of targeted therapeutic strategies. Hence, this study was structured to elucidate the role of neuro-metabolism and its potential mediator in regulating CRC tumorigenesis and metastasis. By delving into the neurometabolic-gut axis in CRC, the resulting mechanistic insights might be leveraged to identify diagnostic and prognostic biomarkers and to develop novel therapeutic interventions for CRC patients.

The purpose of this study is to investigate the effect of tDCS stimulation of cerebellum combined with Xingnaojing on patients with disturbance of consciousness after craniocerebral injury, and to clarify the relationship between the following two points: (1) to clarify whether MMN, P300, fNIRS, BAEP, SEP can be used as objective indicators to distinguish VS from MCS. (2) To clarify the changes of consciousness level and brain function in DoC patients with craniocerebral injury treated with tDCS stimulation of cerebellum combined with Xingnaojing.

The goal of this clinical trial is to examine the efficacy of this manual for mental health in people with mixed neurological disorders, including post-COVID. These conditions are often associated with cognitive impairment, which may hamper the effects of psychoterapy. Executive functioning and especially the ability to abstract thinking may be useful for individuals using Acceptance and Commitment Therapy. Therefore, the main questions research questions are: * Is this intervention effective in improving mental health? * Do executive functions predict the extent of social participation and mental health at the end of therapy? Participants will take part in 8 weekly group therapy sessions of 100 minutes each.

Millions of persons are affected by brain diseases. The CereBank will be used to support research studies aimed at improving the diagnosis and treatment of brain diseases. Brain diseases can be inherited; developed due to diseases or aging; or can be due to trauma. The Central Florida does not have a brain biobank to meet the needs of research. Therefore, it is necessary for the University of Central Florida to establish a brain biobank.

The goal of this clinical trial is to validate an instrumented 3D serious game to assess upper limb impairments in children with neuromotor disorders. The main questions are: * Does an instrumented 3D serious game can provide a set of validated upper limb movement features with good reliability, validity and responsiveness ? * Does the instrumented 3D serious game could provide better immersion, adhesion, usability and satisfaction than a "classic" 3D protocol, thanks to the developped environment ? Researchers will compare children with neuromotor disorders and typically developing children to assess discriminant validity of the new assessement. Children with neuromotor disorders will have 2 visits to the hospital : * Visit 1 : children will perform a validated 3D protocol and the instrumented 3D serious game * Visit 2 : children will have a clinical examination and will perform the instrumented 3D serious game Typically developing children will have one visit to the hospital. They will perform the instrumented 3D serious game.

Neurologic Dysfunction is one of the main factors contributing to poor outcomes in cardiac surgery patients, except for heart failure. Atherosclerosis of the aorta, a history of cerebral infarction, and cervical artery disease are common clinical risk factors for cerebral neurological dysfunction after cardiac surgery. Results of preclinical studies suggested that Angong Niuhuang Pills (ANPs), a traditional Chinese patent medicine, including realgar, cinnabaris, Bovis Calculus, artificial Moschus, and powdered buffalo horn extract, decreased infarct volume and cerebral edema, and presented anti- atherosclerosis and cardio-protective effects in clinical and preclinical studies. The PANDA X trial is designed as a pilot study to explore the safety and efficacy of ANP in patients with moderate-to-severe neurologic dysfunction after cardiovascular surgery.

Acquired brain injury" refers to brain damage that impacts neurological processing, making daily activities challenging and often causing vision issues like binocular dysfunction, oculomotor problems, and visual field loss. In Spain, visual rehabilitation is limited, although it is more common in other countries. These patients generally need an interdisciplinary approach involving professionals like physiotherapists and optometrists and often face mobility, balance, and spatial perception difficulties. Treatment tools include lenses, prisms, and technologies like virtual reality (VR). The Visionary VR program, presented by Dr. Portela, has shown promising results in visual field recovery by stimulating the affected area. Visual rehabilitation is based on brain plasticity and involves three key strategies: Prisms to expand the visual field. Compensatory therapy to improve eye movement. Restitution therapy to restore the visual field.

Acquired brain damage generates motor, cognitive, behavioral and emotional deficits. Neurorehabilitation aims to reduce these deficits and develop compensatory strategies that increase the person's functionality. However, the success of neurorehabilitation process varies and is influenced by the type of injury, the characteristics of the patient or the treatment received. Despite all the studies about patient characteristics, psychological aspects currently continue to be a field to be explored. The main objective of the study is to study the psychological characteristics of people with brain damage. Secondary objectives include analyzing its link with other indicators, exploring possible differences depending on the etiology of brain damage, assessing its evolution during neurorehabilitation and exploring its prognostic value. To carry out this prospective longitudinal observational study, adult patients with acquired brain damage to less than 6 months of evolution who present an objective cognitive alteration will be selected. Patients with a neurological or psychiatric history will be excluded. Patients included in the study will be administered computerized questionnaires at the beginning of the neurorehabilitation program. The same questionnaires will be administered again 2 months later. In those hospitalized patients who subsequently continue outpatient treatment, a third administration will be performed (2 months after the second administration).

The purpose of this research is to determine whether military veterans and service members with mild traumatic brain injury with and without co-occurring substance use can complete and benefit from integrated interdisciplinary care individualized to their symptoms, goals, and needs. Participants will complete surveys about substance use and other symptoms at the beginning and end of treatment in an intensive outpatient program and 6 months after discharge.

A single centre IDEAL Stage 1 feasibility study using novel electrophysiological recording techniques in adult participants undergoing neurosurgery. This is a first in human study, building upon previous preclinical mice experiments. Participants will undergo their planned neurosurgical procedure as normal. In addition to their standard treatment neurophysiological monitoring including an electrocorticography electrode placed on the brain deep to the retractor will be used to monitor for signs of brain retraction injury.

In France, more than 150,000 strokes occur each year. Stroke is a major risk factor for dependency, representing the leading cause of acquired non-traumatic disability in adults. Head injuries, which are also very frequent, can leave similar neuropsychiatric sequelae. These events are brutal and their physical, psychological, emotional, social and financial consequences disrupt the lives of patients and their families. Thanks to improved access to thrombolysis and thrombectomy for the management of acute stroke, the prognosis has been profoundly improved. Nevertheless, the increase in post-stroke survival and the evolution of the type of after-effects require the development of support systems dedicated to these post-stroke patients. The same issues are raised for people who have suffered a head injury with similar consequences that require specialised care. Currently, health care is well structured for the acute phase and there is an improvement in the provision of care in specialised rehabilitation services, but the dedicated medico-social provision for people returning home remains insufficient despite the significant needs. The ARRPAC association (Accompaniment, Rehabilitation, Respite after Stroke and Cerebral Palsy) is setting up a new comprehensive medico-social support programme in Lyon (AVanCer programme, opening in June 2022) to improve the autonomy and adaptation capacities of patients and to relieve the social and psycho-affective burden of carers. This experimental day centre, which complements functional rehabilitation and recurrence prevention care, offers adults with brain injury sequelae and their carers therapeutic education programmes, adapted physical activity, social and cognitive remediation and therapeutic workshops, as well as a place for patients and their carers to exchange information and listen. To achieve its ambition, ARRPAC and the AVanCer programme must be integrated into the existing support offer, create partnerships with care structures and evaluate its added value to ensure its sustainability. In case of efficiency and demonstrated benefits for patients, carers and the health system, such a structure could be deployed in other territories. This study evaluates the implementation of the AVanCer programme in terms of its effect on the target audience, participants' experience and implementation according to the REAIM evaluative framework (Reach, Effectiveness, Adoption, Implementation, and Maintenance).