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The Effect of Transcutaneous Stimulation on Blood Pressure in Spinal Cord Injury (SCI)

RecruitingNAAges 18 Years - 75 YearsAllKessler Foundation
NCT05725499 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This project will investigate the effect of spinal cord transcutaneous stimulation on blood pressure in individuals with a chronic spinal cord injury who experience blood pressure instability, specifically, orthostatic hypotension (a drop in blood pressure when moving from lying flat on your back to an upright position). The main questions it aims to answer are: 1. What are the various spinal sites and stimulation parameters that normalize and stabilize blood pressure during an orthostatic provocation (70 degrees tilt)? 2. Does training, i.e., exposure to repeated stimulation sessions, have an effect on blood pressure stability? Participants will undergo orthostatic tests (lying on a table that starts out flat, then tilts upward up to 70 degrees), with and without stimulation, and changes in their blood pressure will be evaluated.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Spinal cord injury for greater than or equal to 6 months * Injury level ≥ T6 (thoracic level) * American Spinal Injury Association (ASIA) Impairment Scale (AIS) A-D * Exhibits at least one of the following hypotensive symptoms: 1. Baseline hypotension - resting supine or seated systolic blood pressure(SBP) \< 90mmHg; 2. SBP drop ≥ 20 mmHg within 5 minutes of assuming seated position; 3. Symptoms of orthostasis with a drop of SBP (\<90mmHg) from supine to sitting Exclusion Criteria: * Current illness (infection, a pressure injury that might interfere with the intervention, a recent diagnosis of DVT/PE, etc.) * Ventilator-dependent * History of implanted brain/spine/nerve stimulators * Cardiac pacemaker/defibrillator or intra-cardiac lines * Significant coronary artery or cardiac conduction disease, a recent history of myocardial infarction * Insufficient mental capacity to understand and independently provide consent * Pregnancy * Cancer * Deemed unsuitable by study physician
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What it tests

  • Biostim-5 transcutaneous spinal stimulator
  • Tilt-table orthostatic stress testing
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Where

1 site
Kessler Foundation
West Orange, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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