Actively Recruiting
Autonomic Effects of Transcutaneous Spinal Cord Stimulation in Veterans With Spinal Cord Injury
Led by VA Office of Research and Development · Updated on 2025-07-04
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects of transcutaneous spinal cord stimulation in people with spinal cord injury (SCI) to see if it can increase blood pressure, improve exercise power output, and enhance heart rate recovery during arm cycling. The study also explores whether this stimulation helps regulate body temperature in a cool environment. This research involves veterans with SCI and is sponsored by the VA Office of Research and Development. The study includes two parts: Study 1 involves two visits where participants undergo arm cycle ergometry exercises with and without spinal cord stimulation, separated by at least three days. Study 2 also involves two visits to assess core body temperature and thermal comfort in a cool environment with and without the stimulation, again separated by at least three days. Each visit lasts between 2-4 hours depending on the study part. Participants will attend up to seven visits within 60 days, completing arm exercise tests, temperature assessments, and reporting on thermal comfort. Researchers will measure power output, heart rate recovery time, total distance achieved during exercise, body core temperature, and exercise endurance time. Subjective reports on thermal comfort will also be collected. The study includes safety monitoring and aims to gather data over up to two years.
CONDITIONS
Brief Title
Autonomic Effects of Stimulation in SCI
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Injury more than 1 year ago and non-ambulatory
- Level of lesion between C3 and T6, classified as AIS A, B, or C
- Stable prescription medication regimen for at least 30 days
- Able to commit to 7 study visits within a 60-day period
You will not qualify if you...
- Extensive history of seizures
- Ventilator dependence or patent tracheostomy site
- History of neurologic disorder other than spinal cord injury
- History of moderate or severe head trauma
- Contraindications to spine stimulation
- Significant cardiovascular disease
- Active psychological disorder
- Recent history (within 3 months) of substance abuse
- Open skin lesions over spine at levels targeted for stimulation (L1/L2)
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 2 years
Participants undergo transcutaneous spinal cord stimulation to evaluate effects on blood pressure, exercise power output, heart rate recovery, and body temperature regulation.
4 visits (2 for arm ergometry and 2 for cool environment, each separated by at least 3 days)
Trial Site Locations
Total: 1 location
1
James J. Peters VA Medical Center, Bronx, NY
The Bronx, New York, United States, 10468-3904
Actively Recruiting
Research Team
J
Jill Wecht, EdD
M
Matthew T Maher, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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