Active — Not RecruitingNot Applicable

Autonomic Effects of Spinal Cord Stimulation in Spinal Cord Injury

United States20 participantsStarted 2023-07-30

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Exercise Endurance Time

Timeframe: During procedures (30 minutes)

Recovery Heart Rate

Timeframe: During procedures (60 minutes)

Tcore

Timeframe: During procedures (90 minutes)

Thermal Comfort

Timeframe: During procedures (90 minutes)

Trial details

NCT IDNCT05960448

SponsorJames J. Peters Veterans Affairs Medical Center

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2026-07-30

View on ClinicalTrials.gov More Orthostatic Hypotension trials