[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"James J. Peters Veterans Affairs Medical Center\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":119},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,44,75,98],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100645763","ai-guided-predictions-of-blood-pressure-dysregulation-using-perfusion-index-as-a-novel-biomarker-in-persons-with-spinal-cord-injury-100645763",false,"NCT07699094","AI-Guided Predictions of Blood Pressure Dysregulation Using Perfusion Index as a Novel Biomarker in Persons With Spinal Cord Injury","Inclusion Criteria:\n\n* The participant had a spinal cord injury (SCI: C4-T12) for more than one year and the SCI was graded as ASIA Impairment Scale (AIS) A or B (unable to voluntarily move your legs)\n* The participant can also be a gender and age-matched (±5 years) able-bodied (AB) control subject (similar gender and age to a subject with SCI).\n* Subjects with SCI and AB controls must be between 18 and 75 years of age.\n* If the participant are going to do the study, they must avoid caffeine and alcohol, maintain normal salt and water intake, and avoid strenuous exercise for 24 hours prior to the study visit.\n\nExclusion Criteria:\n\n* The participant has cardiovascular, kidney, or untreated thyroid disease\n* The participant has had a traumatic brain injury (TBI)\n* The participant has diabetes mellitus\n* The participant has an acute illness or infection\n* The participant is dehydrated\n* The participant smokes\n* The participant is pregnant\n* The participant has broken, inflamed, or otherwise fragile skin\n* The participant's Body Mass Index (BMI) is more than 30 kg\u002Fm2",true,"ALL","18 Years","75 Years",{"count":20,"type":21},24,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this clinical trial is to determine if perfusion index (PI) can reliably predict changes in systolic blood pressure (SBP) in persons with spinal cord injury (SCI) during a cool temperature challenge. Participants with SCI can be 18-75 years of age, male or female, neurological level of injury C4-T12, ASIA Impairment Scale (AIS: A or B: motor complete) or gender and healthy age-matched able-bodied (AB) controls.\n\nThe main question this study aims to answer is: can PI reliably predict change in SBP during a cool temperature challenge? The investigators hypothesize that PI can be used as a biomarker of SBP in persons with SCI.\n\nResearchers will compare the relationship of 1) changes in PI and SBP and 2) relationship of changes in other vital signs to SBP, during the cool temperature challenge. The researchers aim to determine if PI can be used as a biomarker of SBP in persons with SCI during a cool temperature challenge (experimental group\u002Farm). Able-bodied controls (control group\u002Farm) will receive the same intervention (cool challenge) as the experimental group.\n\nDuring the study, participants will be asked to wear only shorts and a T-shirt so that their skin can be exposed to the warm and cool temperatures of the 2 rooms.\n\nThe investigators will put put on non-invasive sensors (taped or attached on the surface of your body) to measure PI, BP, and other vital signs. The investigators will record these measurements while the participant is seated in a wheelchair for 10 minutes in a warm room and up to 90 minutes in a cool room.",[27,28,29,30],"Spinal Cord Injuries (SCI)","Blood Pressure","Thermoregulation","Perfusion Index","RECRUITING","2026-08-06",{"date":34,"type":35},"2026-08-10","ACTUAL",{"date":37,"type":21},"2026-09-01",{"date":39,"type":21},"2028-06-30",{"name":41,"class":42},"James J. Peters Veterans Affairs Medical Center","FED",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":58,"conditions":59,"keywords":63,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":70,"startDateStruct":71,"completionDateStruct":72,"leadSponsor":74,"locationsCount":43},"100612277","psilocybin-to-treat-depression-in-spinal-cord-injury-100612277","NCT07251491","Psilocybin to Treat Depression in Spinal Cord Injury","Safety, Tolerability, Outcomes of Psilocybin for Depression (STOP Depression) in Veterans With Spinal Cord Injury","STOP","Inclusion Criteria:\n\n* Able and willing to provide informed consent\n* Spinal cord injury for at least 1 year\n* Confirmed diagnosis of depression\n* At least 22 years of age at time of consent\n* At least 50 kg (110 lbs.) body weight\n* Fully independent from ventilatory support (ventilator or diaphragm pacer)\n* Fluent in speaking and reading English\n* Able to swallow pills\n* Agree to have study visits recorded with audio and video\n* Agree to release outside medical and psychiatric records\n* Able and willing to taper off antidepressant, under clinician supervision\n* Agree to use adequate contraceptive methods\n\nExclusion Criteria:\n\n* Are not able to give adequate informed consent\n* Have used psilocybin or another psychedelic within 6 months\n* Have received Electroconvulsive Therapy (ECT) within 12 weeks\n* Have used ketamine within 12 weeks\n* Have a history of Bipolar I Disorder\n* Have a current eating disorder\n* Have a current severe alcohol or cannabis use disorder within the 6 months\n* Have an illicit drug or prescription drug substance use disorder within 12 months\n* Current serious suicide risk\n* History of heart attack, aneurysm, or stroke\n* Uncontrolled hypertension\n* Are pregnant or nursing","22 Years",{"count":54,"type":21},30,[56,57],"PHASE1","PHASE2","The main goal of this study is to determine if psilocybin is safe for use in people with SCI. The study will measure how people with SCI respond to three psilocybin doses: low (5mg), medium (10mg), and high (25mg).\n\nThe main question the study aims to answer is: does psilocybin increase the number and severity of adverse (bad) events reported by people with SCI? These may include pain, muscle spasms, symptoms of depression, and symptoms of low or high blood pressure. The investigators will also measure how well people with SCI tolerate the psychedelic experience, and compare responses between the low (5mg), medium (10mg), and high (25mg) doses.\n\nParticipants will:\n\n* Agree to be enrolled in the study for up to 13 months.\n* Agree to complete the seven (7) visits that are included in the psilocybin-assisted therapy.\n* Agree to complete follow-up study visits, including in-person visits to the James J Peters VA Medical Center, located in the Bronx, New York and remote visits.\n* Agree to keep a log of how they are feeling and any change in the frequency or severity of adverse events.",[60,61,62],"Spinal Cord Injury","Depression - Major Depressive Disorder","Veteran",[64,65,66,67,68,69],"Tetraplegia","Paraplegia","Psychosocial Wellbeing","Depression","Neuropathic Pain","Psychedelics",{"date":34,"type":35},{"date":32,"type":35},{"date":73,"type":21},"2028-03-01",{"name":41,"class":42},{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":83,"enrollmentInfo":84,"targetDuration":4,"studyType":22,"phases":86,"briefSummary":88,"conditions":89,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":91,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},"100503776","treatment-of-orthostatic-hypotension-in-sci-100503776","NCT05839652","Treatment of Orthostatic Hypotension in SCI","Treatment of Orthostatic Hypotension in Individuals With Spinal Cord Injury","SCI","Inclusion Criteria:\n\n* traumatic spinal cord injury\n* at least 12 months post injury\n* injury level of C1-T6\n* AIS A, B or C\n* non-ambulatory\n* non-ventilator\n\nExclusion Criteria:\n\n* Active psychiatric disorder\n* Stroke or cerebrovascular disease\n* Alzheimer's Disease or dementia\n* Unmanaged cardiac arrhythmias\n* Concurrent systemic, hepatic, or renal disease\n* Suspected or diagnosed malignancy\n* Neurological disease other than SCI\n* Self-reported history of three or more symptomatic episodes of AD per day","60 Years",{"count":85,"type":21},25,[87],"PHASE4","The purpose of this study is to identify the effects of non-pharmacological and pharmacological anti-hypotensive treatment interventions on orthostatic hemodynamic responses, symptoms of autonomic dysreflexia and orthostatic hypotension, and levels of fatigue and comfort in hypotensive individuals with SCI.",[90],"Hypotension",{"date":34,"type":35},{"date":93,"type":35},"2023-07-01",{"date":95,"type":21},"2027-06-30",{"name":41,"class":42},2,{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":105,"targetDuration":4,"studyType":22,"phases":107,"briefSummary":108,"conditions":109,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":43},"100366186","seated-balance-using-the-indego-100366186","NCT04047992","Seated Balance Using the Indego™","\"The Effects of Exoskeletal-Assisted Walking on Seated Balance Using the Indego™\"","Inclusion Criteria:\n\n1. Traumatic or non-traumatic SCI ≥6 months duration of SCI;\n2. Wheelchair-user for indoor and outdoor mobility;\n3. Level and completeness of injury T4 and below with complete or incomplete SCI (ISNCSCI A to D);\n4. Able to hold the crutches in hands with or without modifications; and\n5. Able to provide informed consent.\n\nExclusion Criteria:\n\n1. Diagnosis of neurological injury other than SCI;\n2. Progressive condition that would be expected to result in changing neurological status;\n3. Severe concurrent medical disease, illness or condition judged to be contraindicated by the Site Physician;\n4. Anthropocentric incompatibility to be fitted with the device;\n5. Traumatic or high impact lower extremity fracture within the past 2 years;\n6. Fragility, minimal trauma or low impact fracture of the lower extremity since spinal cord injury;\n7. Knee BMD \\\u003C 0.60 gm\u002Fcm2;\n8. Total hip BMD T-scores \\\u003C -3.5;\n9. Untreatable severe spasticity judged to be contraindicated by the Site Physician;\n10. Flexion contracture that is incompatible with the device;\n11. Limitations in ankle range of motion that cannot be adapted with an orthotic device (plantar flexion \\> 00);\n12. Fracture of the foot by x-ray and confirmed by CT;\n13. Untreated or uncontrolled hypertension (systolic blood pressure \\>140 mmHg; diastolic blood pressure \\>90 mmHg);\n14. Unresolved orthostatic hypotension (systolic blood pressure \\\u003C90 mmHg; diastolic blood pressure \\\u003C60 mmHg) as judged to be contraindicated by the Site Physician;\n15. Current pressure ulcer of the arms, trunk, pelvic area, or lower extremities;\n16. History of seizure;\n17. Use of medications that significantly lower seizure threshold, such as tricyclic antidepressants, amphetamines, neuroleptics, dalfampridine, and bupropion;\n18. History of stroke, brain tumor, brain abscess, or multiple sclerosis;\n19. History of moderate or severe head trauma (loss of consciousness for greater than one hour or evidence of brain contusion or hemorrhage or depressed skull fracture on prior imaging);\n20. History of implanted brain\u002Fspine\u002Fnerve simulators, aneurysm clips, ferromagnetic metallic implants, or cardiac pacemaker\u002Fdefibrillator;\n21. Psychopathology documentation in the medical record or history that may conflict with study objectives; and\u002For\n22. Pregnancy or women who plan to become pregnant during the study period.",{"count":106,"type":21},20,[24],"Exoskeleton-assisted walking (EAW) provides a new mobility option and appears to have potential therapeutic benefits for persons with SCI. However, present day technology is not sufficient to replace the wheelchair. During EAW, users stand upright, maintain static and dynamic balance by actively and passively stimulating trunk and lower limb muscles in a manner not challenged during wheelchair use. Preliminary results in our laboratory suggest that the indirect balance challenges and postural perturbations that result during EAW training transfer to better seated balance control, resulting in more independence during seated activities. The purpose of this pilot study is to determine the effects of EAW training on various measures of seated balance (primary outcomes) and body composition (secondary outcomes). Twenty people with SCI (T4 and below) who are wheelchair users for mobility and cannot walk independently will be recruited. The participants will receive 36 sessions of EAW training in 12 weeks. The outcomes will be evaluated pre (baseline) and post (24 and 36 sessions). If EAW devices can be demonstrated to help people with SCI have better seated balance, in addition to the other potential benefits that are being investigated elsewhere, then exoskeletons may have the possibility to be more readily accepted in the clinical, home environments, and by the insurance companies.",[110],"Spinal Cord Injuries","2025-05-09",{"date":113,"type":35},"2025-05-14",{"date":115,"type":35},"2018-02-01",{"date":117,"type":21},"2025-12-31",{"name":41,"class":42},""]