Autonomic Effects of Transcutaneous Spinal Cord Stimulation in Veterans With SCI
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Spinal Cord Injury
- Sponsor
- VA Office of Research and Development
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Power Output
- Status
- Recruiting
- Last Updated
- 10 months ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Power Output
Time Frame: through study completion, up to 2 years
Determine if TSCS increases power output (watts) compared to no stimulation.
Total Distance Achieved
Time Frame: 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
Time Frame: 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
Time Frame: through study completion, up to 2 years
Determine if TSCS helps maintain body core temperature in a cool environment compared to no stimulation.
Secondary Outcomes
- Subjective Reporting on Thermal Comfort and Thermal Sensation(through study completion, up to 2 years)
- Exercise Endurance Time(through study completion, up to 2 years)