Effects of spinal cord stimulation on blood pressure and exercise in spinal cord injury patients
Autonomic Effects of Transcutaneous Spinal Cord Stimulation in Veterans With SCI
This study is testing whether spinal cord stimulation can help people with spinal cord injuries manage their blood pressure and improve their exercise endurance.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (The Bronx, New York) |
| Trial ID | NCT05664646 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of transcutaneous spinal cord stimulation on blood pressure regulation and exercise endurance in individuals with spinal cord injuries. Participants will undergo a series of visits to assess baseline autonomic function, determine optimal stimulation sites on the spine, and evaluate the effects of stimulation during arm cycle ergometry. The study also aims to explore the regulation of body temperature in a cool environment while using the stimulation device. A total of seven visits will be conducted over a 60-day period to gather comprehensive data on these effects.
Who should consider this trial
Good fit: Ideal candidates are non-ambulatory individuals with spinal cord injuries at the C3-T1 level, who are at least one year post-injury.
Not a fit: Patients with extensive seizure history, significant cardiovascular disease, or other neurological disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve blood pressure management and exercise capacity for patients with spinal cord injuries.
How similar studies have performed: While the approach of spinal cord stimulation is being explored, this specific application for blood pressure and exercise in spinal cord injury patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * injury more than 1 year ago, non-ambulatory * level of lesion C3-T6, AIS A, B, or C * stable prescription medication regimen for at least 30 days * must be able to commit to study requirements of 7 visits within a 60-day period Exclusion Criteria: * extensive history of seizures * ventilator dependence or patent tracheostomy site * history of neurologic disorder other than SCI * 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) and pregnancy
Where this trial is running
The Bronx, New York
- James J. Peters VA Medical Center, Bronx, NY — The Bronx, New York, United States (Recruiting)
Study contacts
- Principal investigator: Jill Wecht, EdD — James J. Peters Veterans Affairs Medical Center
- Study coordinator: Jill Wecht, EdD
- Email: jm.wecht@va.gov
- Phone: (718) 584-9000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.