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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 14
Maximum Age: 100
Healthy Volunteers: f
View:

• 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

Locations
United States
New York
The Icahn School of Medicine at Mount Sinai
RECRUITING
New York
Contact Information
Primary
Jorge Chavez, BS
jorge.chavez2@mountsinai.org
(914)343-0713
Backup
Jill M Wecht, EdD
jm.wecht@va.gov
(718)584-9000
Time Frame
Start Date: 2022-01-01
Estimated Completion Date: 2026-10-01
Participants
Target number of participants: 50
Treatments
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.
Sponsors
Leads: Jill M. Wecht, Ed.D.
Collaborators: Icahn School of Medicine at Mount Sinai

This content was sourced from clinicaltrials.gov