Autonomic Effects of Stimulation in SCI

Not Applicable

Recruiting

• Conditions: Spinal Cord Injury

• Registration Number: NCT05664646
• Lead Sponsor: VA Office of Research and Development

Brief Summary

This study aims to determine the effects of transcutaneous spinal cord stimulation to increase blood pressure and use that device to increase power output and heart rate recovery during arm cycle ergometry. In addition, the investigators will see if the stimulation helps regulate body temperature when in a cool environment.

Detailed Description

This study aims to determine the effects of transcutaneous spinal cord stimulation to increase blood pressure and use that device to increase exercise power output and heart rate recovery during arm cycle ergometry. In addition, the investigators will see if the stimulation helps regulate body temperature when in a cool environment. Study 1 (arm cycle ergometry) will consist of 2 visits that will be between 2-3 hours in duration, separated by no less than 3 days, and will consist of putting the electrode at the optimal spot on the spine and completing a submaximal arm ergometry exercise and the other visit will be a sham visit. Study 2 (cool environment) will consist of 2 visits that will be between 3-4 hours in duration, separated by no less than 3 days, and will consist of assessing core temperature when in a cool environment with the stimulator on and off.

Study Timeline

• Study First Submitted: 2022-12-15
• Study First Submitted QC: 2022-12-15
• Study First Posted: 2022-12-27
• Study Start: 2023-07-24
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-01
• Last Update Posted: 2025-07-04
• Primary Completion: 2026-07-30
• Study Completion: 2026-07-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• injury more than 1 year ago, non-ambulatory
• level of lesion C3-T6, AIS A, B, or C
• stable prescription medication regimen for at least 30 days
• must be able to commit to study requirements of 7 visits within a 60-day period

Exclusion Criteria

• extensive history of seizures
• ventilator dependence or patent tracheostomy site
• history of neurologic disorder other than SCI
• history of moderate or severe head trauma
• contraindications to spine stimulation
• significant cardiovascular disease
• active psychological disorder
• recent history (within 3 months) of substance abuse
• open skin lesions over spine at levels targeted for stimulation (L1/L2) and pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Power Output	through study completion, up to 2 years	Determine if TSCS increases power output (watts) compared to no stimulation.
Total Distance Achieved	through study completion, up to 2 years	Determine if TSCS increases total distance (miles) achieved during arm ergometry compared to no stimulation.
Heart Rate Recovery Time	through study completion, up to 2 years	Determine if TSCS shortens the amount of time for HR recovery (return to baseline) compared to no stimulation.
Body Core Temperature	through study completion, up to 2 years	Determine if TSCS helps maintain body core temperature in a cool environment compared to no stimulation.

Secondary Outcome Measures

Name	Time	Method
Subjective Reporting on Thermal Comfort and Thermal Sensation	through study completion, up to 2 years	To determine if TSCS helps improve subjective reporting on thermal comfort and thermal sensation compared to no stimulation.
Exercise Endurance Time	through study completion, up to 2 years	Determine if TSCS increases exercise endurance time compared to no stimulation.

Trial Locations

Locations (1)

James J. Peters VA Medical Center, Bronx, NY; 🇺🇸 Bronx, New York, United States