Autonomic Effects of Stimulation in SCI

VA Office of Research and Development20 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Spinal Cord Injury

Interventions

Transcutaneous Spinal Cord Stimulation (TSCS)DEVICE

Non-invasive electrical stimulation of the spinal cord.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

James J. Peters VA Medical Center, Bronx, NY

The Bronx, New York, United States

Outcomes

Primary Outcomes

Study 1. Arm Cycle Ergometry Outcome - Peak Workload

Difference between active transcutaneous spinal cord stimulation (TSCS) and sham TSCS conditions, measured in watts.