Autonomic Effects of Stimulation in SCI

VA Office of Research and Development

Status: Enrolling

Conditions: Spinal Cord Injury

Treatments: Device: DS8R; Other: Arm Ergometry; Other: Cool Environment

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT05664646

1I21RX004373-01A1 (Other Grant/Funding Number)

B4373-P

Details and patient eligibility

About

This study aims to determine the effects of transcutaneous spinal cord stimulation to increase blood pressure and use that device to increase exercise endurance time 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.

Full description

This study aims to determine the effects of transcutaneous spinal cord stimulation to increase blood pressure and use that device to increase exercise endurance time 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. The study will consist of 7 visits, that will be between 3-4 hours in duration, separated by no less than 3 days. Visit 1 will consist of determining baseline autonomic function and screening visit. The participant will undergo a sit up set to determine hypotension and orthostatic hypotension and complete a couple surveys. Visits 2 and 3 will determine which site the stimulation parameters should be on the spine, either T7-T8 or T11-12. The site that increases seated systolic blood pressure will be used for the rest of the study. Visits 4 and 5 will consists 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. Visits 6 and 7 will consist of assessing core temperature when in a cool environment with the stimulator on and off.

Enrollment: 20 estimated patients

Sex: All

Ages: 35 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• injury more than 1 year ago, non-ambulatory
• level of lesion C3-T1, AIS A or B
• 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 (T7/8, T11/12) and pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Without stimulation

Sham Comparator group

Description:

For study 1, exercise endurance time and heart rate recovery will be measured after arm ergometry without stimulation. For study 2, body core temperature and thermal comfort will be reported without stimulation.

Treatment:

Other: Cool Environment

Other: Arm Ergometry

With stimulation

Active Comparator group

Description:

For study 1, exercise endurance time and heart rate recovery will be measured after arm ergometry with stimulation. For study 2, body core temperature and thermal comfort will be reported with stimulation.

Treatment:

Other: Cool Environment

Other: Arm Ergometry

Device: DS8R