Spinal Cord Injuries Clinical Trial
Official title:
Safety, Feasibility, and Efficacy of Transcutaneous Spinal Cord Stimulation on Stabilizing Blood Pressure for Acute Inpatients With Spinal Cord Injury
Current forms of pharmacologic and non-pharmacologic treatments for hypotension and orthostatic hypotension (OH) remain inadequate during acute inpatient rehabilitation (AIR) following a traumatic spinal cord injury (SCI). A critical need exists for the identification of safe, practical, and effective treatment options that stabilize blood pressure (BP) after traumatic SCI. Recent published evidence suggests that transcutaneous Spinal Cord Stimulation (TSCS) can be used to raise seated BP, and mitigate the falls in BP during orthostatic repositioning in individuals with chronic SCI. This site-specific project will focus on the use of TSCS to stabilizing seated BP and mitigate the fall in BP during orthostatic repositioning during AIR following traumatic SCI.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | October 1, 2026 |
Est. primary completion date | August 31, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 14 Years to 100 Years |
Eligibility | Inclusion Criteria: - Newly injured patients with traumatic SCI - Admitted to Acute Inpatient Rehabilitation at Mount Sinai - Within one year of SCI - Seated hypotension (systolic BP = 110 mmHg for males or = 100 mmHg for females) - Orthostatic hypotension (fall in systolic BP = 20 mmHg and/or a fall in diastolic BP = 10 mmHg within 10 minutes of assuming an upright position) - Daily fluctuation in systolic BP = 20 mmHg and/or fluctuation in diastolic BP = 10 mmHg - At least 14 years old Exclusion Criteria: - Implanted brain/spine/nerve stimulators - Cochlear implants - Cardiac pacemaker/defibrillator, or intracardiac lines - Open skin lesions on or near the electrode placement sites (neck, upper back) - Significant coronary artery or cardiac conduction disease - Recent history of myocardial infarction - Insufficient mental capacity to understand and independently provide consent - Pregnancy - Cancer - Deemed unsuitable by study physician |
Country | Name | City | State |
---|---|---|---|
United States | The Icahn School of Medicine at Mount Sinai | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Jill M. Wecht, Ed.D. | Icahn School of Medicine at Mount Sinai |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The efficacy (#1) of TSCS to improve autonomic control following acute SCI. | Blood pressure changes (mmHg) during the sit-up test with TSCS compared to no stimulation. | Acute Inpatient Rehabilitation following SCI (up to 4 months) | |
Primary | The safety (#1) of TSCS to improve autonomic control following acute SCI. | Assess pain levels using a Likert Scale 0-10 (0=no pain, 10=worst pain). | Acute Inpatient Rehabilitation following SCI (up to 4 months) | |
Primary | The safety (#2) of TSCS to improve autonomic control following acute SCI. | Document any skin changes (burns) following use of TSCS in count of occurrences. | Acute Inpatient Rehabilitation following SCI (up to 4 months) | |
Secondary | The efficacy (#2) of TSCS to improve autonomic control following acute SCI. | To compare dizziness symptoms on a Likert Scale 0-10 (0=no dizziness, 10=worst dizziness) during the sit-up test with TSCS compared to no stimulation.. | Acute Inpatient Rehabilitation following SCI (up to 4 months) |
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