Status:
RECRUITING
Safety, Feasibility, and Efficacy of TSCS on Stabilizing Blood Pressure for Acute Inpatients With SCI
Lead Sponsor:
Jill M. Wecht, Ed.D.
Collaborating Sponsors:
Icahn School of Medicine at Mount Sinai
Conditions:
Acute Spinal Cord Injury
Spinal Cord Injuries
Eligibility:
All Genders
14-100 years
Phase:
NA
Brief Summary
Current forms of pharmacologic and non-pharmacologic treatments for hypotension and orthostatic hypotension (OH) remain inadequate during acute inpatient rehabilitation (AIR) following a traumatic spi...
Detailed Description
Based on available evidence, TSCS may have advantages over current pharmacological approaches to the treatment of hypotension and OH: (1) does not exacerbate polypharmacy, (2) can be activated/deactiv...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06000592
Start Date
January 1 2022
End Date
October 1 2026
Last Update
April 2 2024
Active Locations (1)
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1
The Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029