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
This trial does not accept healthy volunteersQualifiers
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
Single group
Treatments tested in this trial
Digitimer
Devicetranscutaneous spinal cord stimulation for blood pressure control following spinal cord injury.
Treatment groups
Trial outcomes
Primary outcomes
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.
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).
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.
Secondary outcomes
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..
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Jill M. Wecht, Ed.D.
Lead sponsor
James J. Peters Veterans Affairs Medical Center
Sponsor institution
Icahn School of Medicine at Mount Sinai
Collaborator