Autonomic Effects of Stimulation in SCI (NCT05664646) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Autonomic Effects of Stimulation in SCI
United States20 participantsStarted 2023-07-24
Plain-language summary
This study aims to determine the effects of transcutaneous spinal cord stimulation to increase blood pressure and use that device to increase power output and heart rate recovery during arm cycle ergometry. In addition, the investigators will see if the stimulation helps regulate body temperature when in a cool environment.
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:
* 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
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
1
Study 1. Arm Cycle Ergometry Outcome - Peak Workload
Timeframe: through study completion, up to 2 years
2
Study 1. Arm Cycle Ergometry Outcome - Total Exercise Time
Timeframe: through study completion, up to 2 years
3
Study 1. Arm Cycle Ergometry Outcome - Recovery Heart Rate
Timeframe: through study completion, up to 2 years
4
Study 2. Thermoregulatory Outcome - Core Temperature
Timeframe: through study completion, up to 2 years
5
Study 2. Thermoregulatory Outcome - Thermal Comfort
Timeframe: through study completion, up to 2 years
6
Study 2. Thermoregulatory Outcome - Thermal Sensation
Timeframe: through study completion, up to 2 years