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

Part of paid clinical trials in New York, New York.

Sponsor
Jill M. Wecht, Ed.D.
Study ID
NCT06000592
Status
Recruiting
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Conditions

  • Acute Spinal Cord Injury
  • Blood Pressure
  • Blood Pressure Disorders
  • Neuromodulation
  • SCI - Spinal Cord Injury
  • Spinal Cord Injuries
  • Spinal Cord Stimulation
  • Traumatic Spinal Cord Injury

Eligibility Criteria

Sex
ALL
Age
14 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Digitimer — DEVICE
    transcutaneous spinal cord stimulation for blood pressure control following spinal cord injury.

Study Details

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.

Key Dates

Start date
Jan 1, 2022
Status verified
Apr 2024
Primary completion
Aug 31, 2026
Completion
Oct 1, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: transcutaneous spinal stimulation
    Transcutaneous spinal cord stimulation (TSCS) protocol to stabilize seated systolic blood pressure in newly injured patients with spinal cord injury and to test the ability of TSCS to reduce the fall in blood pressure when these patients are moved from the supine to the seated position.

Primary Outcome Measure

The efficacy (#1) of TSCS to improve autonomic control following acute SCI. [ Time Frame: Acute Inpatient Rehabilitation following SCI (up to 4 months) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Icahn School of Medicine at Mount SinaiNew YorkNew York10029
Miguel Escalón, MD, MPH
[email protected]
212-241-6321

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By research site
The Icahn School of Medicine at Mount Sinai· New York, NY

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