Cardiovascular Function and Response to Stimulation Within the First Year After Spinal Cord Injury
Kessler Foundation · NCT06841198
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18–75 · All sexes
- Healthy volunteers
- Accepted
- Study type
- Interventional · Not applicable
- Target enrollment
- 15
- US sites recruiting
- 1
- Study start
- April 1, 2025
- Record last updated
- July 1, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: spinal cord transcutaneous stimulation; Ice testing
Conditions: Spinal Cord Injuries (SCI); Orthostatic Hypotension, Dysautonomic; Cardiovascular; Transcutaneous Spinal Stimulation
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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
Recruiting US locations
Kessler Foundation
West Orange, NJ 07052
Study contacts (from the official record)
- Leighann Martinez, BA · (973)324-3557 · lmartinez@kesslerfoundation.org
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