Cardiovascular Function and Response to Stimulation Within the First Year After Spinal Cord Injury (NCT06841198) | Clinical Trial Compass
RecruitingNot Applicable
Cardiovascular Function and Response to Stimulation Within the First Year After Spinal Cord Injury
United States5 participantsStarted 2025-04-01
Plain-language summary
The study aims to explore how cardiovascular function changes in the first year after a spinal cord injury, and to see how different treatments, like spinal stimulation through the skin (transcutaneous spinal stimulation), affect blood pressure.
The main questions are:
How does stimulation affect blood pressure over the year? What is the level of cardiovascular activation throughout the year?
The study will start during the inpatient stay at the Kessler Institute for Rehabilitation and continue after discharge as an outpatient, totaling about 20-29 sessions over the year.
Who can participate
Age range
18 Years – 75 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:
* Individuals with a spinal cord injury undergoing inpatient rehabilitation at the Kessler Institute for Rehabilitation
* Between 18-75 years old
* 7-50 days after injury
* Injury level ≥ T6 (a cervical or a high-level chest injury)
* Individuals experiencing low blood pressure after the injury
* American Spinal Injury Association Impairment Scale (AIS) A or B
Exclusion Criteria:
* A ventilator is needed for breathing.
* Devices such as brain/spine/nerve stimulators, a cardiac pacemaker/defibrillator, or intra-cardiac lines are present in the body.
* There is a significant disease affecting the blood vessels or signals in the heart, or a recent heart attack (myocardial infarction) has occurred.
* A new medication has been prescribed to treat blood pressure or a heart problem within the last five days (excluding midodrine).
* There is a known infection in the body (e.g., urinary tract infection) or a current illness (e.g., recent diagnosis of deep vein thrombosis (DVT) or other blood clotting issues, and/or a pressure injury that might interfere with the study).
* There is a history of seizures.
* 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
Systolic blood pressure in seated mapping sessions
Timeframe: The procedure will be repeated throughout the year, starting shortly after the injury and occurring approximately once a month.
2
systolic blood pressure in a 70 degree tilt
Timeframe: The procedure will be repeated throughout the year, starting shortly after the injury and occurring approximately every three months