About this trial
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 criteria
Qualifiers
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)
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Digitimer
Treatment groups
Sponsors and collaborators
Jill M. Wecht, Ed.D.
Lead sponsor
James J. Peters Veterans Affairs Medical Center
Sponsor institution
Icahn School of Medicine at Mount Sinai
Collaborator