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

Description

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.

Conditions

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

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

Safety, Feasibility, and Efficacy of Transcutaneous Spinal Cord Stimulation on Stabilizing Blood Pressure for Acute Inpatients With Spinal Cord Injury

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

Condition
Acute Spinal Cord Injury
Intervention / Treatment

-

Contacts and Locations

New York

The Icahn School of Medicine at Mount Sinai, New York, New York, United States, 10029

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

14 Years to 100 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Jill M. Wecht, Ed.D.,

Thomas N Bryce, MD, STUDY_DIRECTOR, Icahn School of Medicine at Mount Sinai

Study Record Dates

2026-10-01