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| ID | Type | Description | Link |
|---|---|---|---|
| 1I21RX004373-01A1 | U.S. NIH Grant/Contract | View source |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Without stimulation | Experimental | For study 1, exercise power output 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. |
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| With stimulation | Experimental | For study 1, exercise power output 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous Spinal Cord Stimulation | Device | Non-invasive electrical stimulation of the spinal cord. |
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| Measure | Description | Time Frame |
|---|---|---|
| Study 1. Arm Cycle Ergometry Outcome - Peak Workload | Difference between active TSCS and sham TSCS conditions, measured in watts. | through study completion, up to 2 years |
| Study 1. Arm Cycle Ergometry Outcome - Total Exercise Time | Difference between active TSCS and sham TSCS conditions, measured in minutes. | through study completion, up to 2 years |
| Study 1. Arm Cycle Ergometry Outcome - Recovery Heart Rate | Difference between active TSCS and sham TSCS conditions, measured at 1 minute, 2 minutes, and 5 minutes. | through study completion, up to 2 years |
| Study 2. Thermoregulatory Outcome - Core Temperature | Difference between active TSCS and sham TSCS conditions, measured in degrees Celsius. | through study completion, up to 2 years |
| Study 2. Thermoregulatory Outcome - Thermal Comfort | Difference between active TSCS and sham TSCS conditions, measured using a Likert scale. | through study completion, up to 2 years |
| Study 2. Thermoregulatory Outcome - Thermal Sensation | Difference between active TSCS and sham TSCS conditions, measured using a Likert scale. | through study completion, up to 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jill Wecht, EdD | James J. Peters Veterans Affairs Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| James J. Peters VA Medical Center, Bronx, NY | The Bronx | New York | 10468-3904 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jul 8, 2025 | Jun 30, 2026 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D007024 | Hypotension, Orthostatic |
| D009043 | Motor Activity |
| D007022 | Hypotension |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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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).
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During both Study 1 and Study 2, the participants will be blinded to the order of completing the study with and without stimulation.
| D014947 | Wounds and Injuries |
| D054971 | Orthostatic Intolerance |
| D054969 | Primary Dysautonomias |
| D001342 | Autonomic Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001519 | Behavior |