Safety, Feasibility, and Efficacy of TSCS on Stabilizing Blood Pressure for Acute Inpatients With SCI

ID#: NCT06000592

Age: 14 - 100 years

Gender: All

Healthy Subjects: No

Study Phase: N/A

Recruitment Status: Recruiting

Start Date: January 01, 2022

End Date: October 01, 2026

Contact Information:
Jorge Chavez, BS
(914)343-0713
Jill M Wecht, EdD
(718)584-9000
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 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.
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
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