Cardiovascular Function and Response to Stimulation Within the First Year After Spinal Cord Injury
Recruiting now · Not applicable
Conditions studied: Spinal Cord Injuries (SCI), Orthostatic Hypotension, Dysautonomic, Cardiovascular, Transcutaneous Spinal Stimulation
In brief
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.
Key facts
- Study ID
- NCT06841198
- Run by
- Kessler Foundation
- People needed
- 15
- Starts
- 2025-04-01
- Expected to finish
- 2026-11-01
- Last updated by the study team
- 2026-07-01
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 is running
- Kessler Foundation — West Orange, New Jersey, United States (enrolling)
Full record on ClinicalTrials.gov
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