Effects of spinal cord stimulation on exercise and temperature regulation in spinal cord injury
Autonomic Effects of Transcutaneous Spinal Cord Stimulation in Veterans With Spinal Cord Injury (SCI)
This study is testing if a new type of spinal cord stimulation can help people with spinal cord injuries exercise longer and better manage their body temperature.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | James J. Peters Veterans Affairs Medical Center Federal |
| Locations | 1 site (The Bronx, New York) |
| Trial ID | NCT05960448 on ClinicalTrials.gov |
What this trial studies
This interventional crossover study aims to evaluate the impact of transcutaneous spinal cord stimulation (TSCS) on exercise endurance and core body temperature regulation in individuals with chronic spinal cord injury (SCI). Participants will undergo both active and sham TSCS while engaging in arm cycling exercises and being exposed to a cool environment. The study will assess heart rate recovery, exercise endurance, and subjective thermal comfort to determine the efficacy of TSCS in improving autonomic functions related to blood pressure control and thermoregulation.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with chronic spinal cord injuries between C3-T6 who have participated in a prior related experiment.
Not a fit: Patients with a history of seizures, diabetes, or other significant neurological or cardiovascular conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance exercise capacity and thermal comfort for patients with spinal cord injuries.
How similar studies have performed: While this approach is novel in its specific application, similar studies have shown promise in using neuromodulation techniques for improving autonomic functions in SCI patients.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * You are above the age of 18 years old * You have an SCI between C3-T6 * You have been injured longer than 1 year * You participated in a prior experiment "Targeted Transcutaneous Spinal Cord Stimulation to Restore Autonomic Cardiovascular Health in Individuals with Spinal Cord Injury" * You have an American Spinal Injury Association injury classification scale (AIS) A, B, C * Your prescription medications have not changed for at least 30 days Exclusion Criteria: * You have a history of seizures * You have an acute illness or infection * You have diabetes * You have untreated thyroid disease * You have a neurological condition other than SCI (Alzheimer's disease, dementia, stroke, multiple sclerosis, Parkinson's disease, etc.) * You have a history of heart or vascular disease (coronary artery disease, congestive heart failure, peripheral artery disease,) * You have a history of moderate or severe head trauma (TBI) or diagnosed with cognitive impairment * You have a present or history of a psychological disorder * You have contraindications to electricity over your spine * You are dependent on a ventilator to breathe or have an open tracheostomy site * You have a recent history of substance abuse (within the past 3 months) * You have open wounds over the spine at the level targeted for stimulation * You are pregnant
Where this trial is running
The Bronx, New York
- James J Peters VAMC — The Bronx, New York, United States (Recruiting)
Study contacts
- Principal investigator: Jill M Wecht, EdD — James J. Peters Veterans Affairs Medical Center
- Study coordinator: Matthew T Maher, MS
- Email: Matthew.Maher@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.