💬In plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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):
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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
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