NCT05664646

Autonomic Effects of Stimulation in SCI

Autonomic Effects of Transcutaneous Spinal Cord Stimulation in Veterans With SCI

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Spinal Cord Injury

Interventions

Type	Name	Description
DEVICE	DS8R	transcutaneous stimulation of the spinal cord.
OTHER	Arm Ergometry	Study 1 will use the arm ergometry as a form of exercise.
OTHER	Cool Environment	Study 2 will be completed in a cool environment setting.

Timeline

• Start date: 2023-07-24
• Primary completion: 2026-07-30
• Completion: 2026-07-30
• First posted: 2022-12-27
• Last updated: 2025-07-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study