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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-100
SponsorJill M. Wecht, Ed.D.

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 volunteers

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

Design model

Single group

Treatments tested in this trial

  • Digitimer

    Device

    transcutaneous spinal cord stimulation for blood pressure control following spinal cord injury.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: transcutaneous spinal stimulationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Acute Inpatient Rehabilitation following SCI (up to 4 months)
2

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).

Time frame
Acute Inpatient Rehabilitation following SCI (up to 4 months)
3

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.

Time frame
Acute Inpatient Rehabilitation following SCI (up to 4 months)

Secondary outcomes

1

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..

Time frame
Acute Inpatient Rehabilitation following SCI (up to 4 months)

Other outcomes

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