Spinal Cord Injury
Conditions
Keywords
Orthostatic Hypotension, Exercise, Hypotension, Body Core Temperature, Blood Pressure
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.
Interventions
Non-invasive electrical stimulation of the spinal cord.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
During both Study 1 and Study 2, the participants will be blinded to the order of completing the study with and without stimulation.
Intervention model description
During the study 1 visits, the participants will complete an arm ergometry exercise with the optimal stimulation parameters and without (sham). During study 2 visits, the participants' body core temperature will be measured about being exposed to a cool environment with stimulation and without (sham).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Study 1. Arm Cycle Ergometry Outcome - Peak Workload | through study completion, up to 2 years | Difference between active transcutaneous spinal cord stimulation (TSCS) and sham TSCS conditions, measured in watts. |
| Study 1. Arm Cycle Ergometry Outcome - Total Exercise Time | through study completion, up to 2 years | Difference between active transcutaneous spinal cord stimulation (TSCS) and sham TSCS conditions, measured in minutes. |
| Study 1. Arm Cycle Ergometry Outcome - Recovery Heart Rate | through study completion, up to 2 years | Difference between active transcutaneous spinal cord stimulation (TSCS) and sham TSCS conditions, measured at 1 minute, 2 minutes, and 5 minutes. |
| Study 2. Thermoregulatory Outcome - Core Temperature | through study completion, up to 2 years | Difference between active transcutaneous spinal cord stimulation (TSCS) and sham TSCS conditions, measured in degrees Celsius. |
| Study 2. Thermoregulatory Outcome - Thermal Comfort | through study completion, up to 2 years | Difference between active transcutaneous spinal cord stimulation (TSCS) and sham TSCS conditions, measured using a Likert scale. |
| Study 2. Thermoregulatory Outcome - Thermal Sensation | through study completion, up to 2 years | Difference between active transcutaneous spinal cord stimulation (TSCS) and sham TSCS conditions, measured using a Likert scale. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJill Wecht, EdD
James J. Peters Veterans Affairs Medical Center
Outcome results
None listed