Clinical trials

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Search and review clinical trials. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

AI-Guided Predictions of Blood Pressure Dysregulation Using Perfusion Index as a Novel Biomarker in Persons With Spinal Cord Injury

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. The main question this study aims to answer is: can PI reliably predict change in SBP during a cool temperature challenge? We hypothesize that PI can be used as a biomarker of SBP in persons with SCI. Researchers 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/arm). Able-bodied controls (control group/arm) will receive the same intervention (cool challenge) as the experimental group. During 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. We will put put on non-invasive sensors (taped or attached on the surface of your body) to measure PI, BP, and other vital signs. We will record these measurements while you are seated in a wheelchair for 10 minutes in a warm room and up to 90 minutes in a cool room.

Participants needed: 24
Trial details
Age: 18-75Biological sex: AllType: InterventionalSponsor: James J. Peters Veterans Affairs Medical CenterUpdated: Jul 13, 2026Locations: 1
Eligibility criteria

You have had a spinal cord injury (SCI: C4-T12) for more than one year and the S... [+3]

You have cardiovascular, kidney, or untreated thyroid disease [+8]

Status: Recruiting

Psilocybin to Treat Depression in Spinal Cord Injury

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). The 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. Participants will: * Agree to be enrolled in the study for up to 13 months. * Agree to complete the seven (7) visits that are included in the psilocybin-assisted therapy. * 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. * Agree to keep a log of how they are feeling and any change in the frequency or severity of adverse events.

Participants needed: 30
Trial details
Phase: Phase 1, Phase 2Age: 22+Biological sex: AllType: InterventionalSponsor: James J. Peters Veterans Affairs Medical CenterUpdated: May 4, 2026Locations: 1
Eligibility criteria

Able and willing to provide informed consent [+11]

Are not able to give adequate informed consent [+11]

Status: Recruiting

Seated Balance Using the Indego™

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.

Participants needed: 20
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: James J. Peters Veterans Affairs Medical CenterUpdated: May 14, 2025Locations: 1
Eligibility criteria

Traumatic or non-traumatic SCI ≥6 months duration of SCI; [+4]

Diagnosis of neurological injury other than SCI; [+21]

Status: Recruiting

Autonomic Effects of Spinal Cord Stimulation in Spinal Cord Injury

The goal of this interventional crossover study is to determine the effects of transcutaneous spinal cord stimulation (TSCS) on the ability to perform moderate exercise and regulate core body temperature in the chronic spinal cord injury community. The main questions it aims to answer are: * What are the effects of active TSCS targeted for BP control on exercise endurance time and HR recovery during submaximal arm cycle ergometry (ACE) as compared to sham TSCS in participants with chronic, cervical SCI? * What are the effects of active TSCS on Tcore responses to cool ambient exposure and on subjective reporting of thermal comfort and thermal sensitivity as compared to sham TSCS. Participants will receive sham and active stimulation while using an arm bicycle or while in a cold room. Participants are free to participate in either the exercise phase, the cold room phase, or both phases of this study. Please note that there no expected long term benefits of this study.

Participants needed: 20
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: James J. Peters Veterans Affairs Medical CenterUpdated: Oct 1, 2024Locations: 1
Eligibility criteria

You are above the age of 18 years old [+5]

You have a history of seizures [+12]

Status: Recruiting

Treatment of Orthostatic Hypotension in SCI

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.

Participants needed: 25
Trial details
Phase: Phase 4Age: 18-60Biological sex: AllType: InterventionalSponsor: James J. Peters Veterans Affairs Medical CenterUpdated: Oct 1, 2024Locations: 2
Eligibility criteria

traumatic spinal cord injury [+5]

Active psychiatric disorder [+7]