Actively Recruiting
Safety, Feasibility, and Efficacy of TSCS on Stabilizing Blood Pressure for Acute Inpatients With SCI
Led by Jill M. Wecht, Ed.D. · Updated on 2024-04-02
50
Participants Needed
1
Research Sites
247 weeks
Total Duration
On this page
Sponsors
J
Jill M. Wecht, Ed.D.
Lead Sponsor
I
Icahn School of Medicine at Mount Sinai
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety, Feasibility, and Efficacy of TSCS on Stabilizing Blood Pressure for Acute Inpatients With SCI
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly injured patients with traumatic spinal cord injury
- Admitted to Acute Inpatient Rehabilitation at Mount Sinai
- Within one year of spinal cord injury
- Seated hypotension (systolic blood pressure 64 110 mmHg for males or 64 100 mmHg for females)
- Orthostatic hypotension (fall in systolic blood pressure 65 20 mmHg and/or fall in diastolic blood pressure 65 10 mmHg within 10 minutes of standing)
- Daily fluctuation in systolic blood pressure 65 20 mmHg and/or fluctuation in diastolic blood pressure 65 10 mmHg
- At least 14 years old
You will not qualify if you...
- Implanted brain, spine, or nerve stimulators
- Cochlear implants
- Cardiac pacemaker, defibrillator, or intracardiac lines
- Open skin lesions on or near electrode placement sites (neck, upper back)
- Significant coronary artery or cardiac conduction disease
- Recent history of myocardial infarction
- Insufficient mental capacity to understand and provide consent
- Pregnancy
- Cancer
- Deemed unsuitable by study physician
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
Research Team
J
Jorge Chavez, BS
CONTACT
J
Jill M Wecht, EdD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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