TSCS for Acute SCI

NARecruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

January 1, 2022

Primary Completion Date

August 31, 2027

Study Completion Date

October 1, 2027

Conditions
Acute Spinal Cord InjuryBlood PressureHypotension
Interventions
PROCEDURE

TSCS Mapping

"Prior to TSCS Intervention, participants will undergo TSCS Mapping.~Electrode location, pulse frequency will be maintained while the stimulation intensity is ramped from 10 to 200 mA. Brachial blood pressures and symptoms will be monitored and recorded at each ramping interval and will continuously monitor and record beat-to-beat heart rate and blood pressures to determine the optimal site and frequency for further TSCS intervention~TSCS electrodes will be placed at two vertebral levels in the and back and pulse frequency will be set at 30 to 240 Hz to determine the optimal site and frequency for further TSCS intervention."

DEVICE

Transcutaneous spinal cord stimulation

"TSCS will be used as an adjunct intervention to promote blood pressure stability in conjunction with daily physical and occupational therapy in the inpatient rehabilitation gym. Stimulation will be added to therapy 3-5 times per week as needed for the duration of inpatient hospitalization following SCI.~TSCS stimulation will be delivered using Digitimer DS7A, DS8R stimulators and Chattanooga Continuum (DS7A has FDA 510(k) clearance #K051357; Chattanooga Continuum is a Class 2 device)."

Trial Locations (1)

10029

RECRUITING

Mount Sinai Spinal Cord Injury Model System, New York

All Listed Sponsors
collaborator

James J. Peters Veterans Affairs Medical Center

FED

lead

Icahn School of Medicine at Mount Sinai

OTHER