How transcutaneous spinal stimulation affects heart function and blood pressure during the first year after spinal cord injury
Official title: Assessing Cardiovascular Effects: Is There a Time Too Early for Spinal Stimulation in Acute SCI? A Year-Long Evaluation of Autonomic Function Following Injury
Run by Kessler Foundation · NCT06841198 · Data updated 2026-11-12
The team will try transcutaneous spinal cord stimulation to see if it helps stabilize blood pressure in adults (18–75) with recent high-level spinal cord injuries who have low blood pressure and orthostatic symptoms.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 15 (estimated) |
| Sponsor | Kessler Foundation Academic / other |
| Locations | 1 site (West Orange, New Jersey) |
| Status | Recruiting |
| Started | April 1, 2025 |
| Main results expected | November 2026 |
| Study ends | November 2026 |
| Registry record updated | July 1, 2026 |
| Trial ID | NCT06841198 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults 18–75 who are 7–50 days post-injury with a spinal cord lesion at or above T6, AIS A or B classification, low blood pressure and orthostatic hypotension, and who are receiving inpatient rehabilitation at Kessler.
✕Probably not a fit
People who require mechanical ventilation, have implanted cardiac or neural stimulators, significant cardiovascular disease or a recent myocardial infarction, active infection, or a very recent change in blood pressure medications are excluded and unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional protocol follows five adults with recent spinal cord injury through their first post-injury year to map cardiovascular responses to transcutaneous spinal cord stimulation (scTS). Participants begin during inpatient rehabilitation at Kessler with 5–11 assessment and stimulation-mapping sessions including 24-hour blood pressure monitoring, tilt tests, cold pressor testing, and autonomic questionnaires, then continue monthly outpatient mapping for a total of about 20–29 sessions over the year. The study measures immediate blood pressure responses to stimulation and tracks how those responses and autonomic activation patterns evolve at 6, 9, and 12 months post-injury. The aim is to identify optimal timing and stimulation patterns to improve cardiovascular control after spinal cord injury.
Why it matters
Potential benefit: If successful, scTS could provide a noninvasive way to reduce low blood pressure and orthostatic symptoms and improve daily function after spinal cord injury.
How similar studies have gone: Small pilot studies of epidural and transcutaneous spinal stimulation have shown promising increases in blood pressure and reductions in orthostatic intolerance, but timing and long-term effects in the first post-injury year remain under-studied.
Who can join: the full rules
Show full inclusion / exclusion criteria
For the main study: 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. For the spin-off study ice-water vs ice-wrap test (see description in study arms): \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Inclusion: Age 18-75. Inclusion for individuals with SCI: * Injury sustained more than 6 months ago * Injury level ≥ T6 (a cervical or a high-level chest injury) * American spinal injury association impairment scale (AIS) A - D Exclusion: Foot lesions, uses a ventilator, devices such as brain/spine/nerve stimulators, significant or recent cardiovascular disease, known infection in the body
Where it's running
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Kessler Foundation
West Orange, New Jersey, United States Recruiting
Study contacts
- Principal investigator: Einat Engel-Haber, MD — Kessler Foundation
- Study coordinator: Leighann Martinez, BA
- Email: lmartinez@kesslerfoundation.org
- Phone: (973)324-3557
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.