Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this interventional crossover study is to determine the effects of transcutaneous spinal cord stimulation (TSCS) on the ability to perform moderate exercise and regulate core body temperature in the chronic spinal cord injury community. The main questions it aims to answer are:
Participants will receive sham and active stimulation while using an arm bicycle or while in a cold room. Participants are free to participate in either the exercise phase, the cold room phase, or both phases of this study.
Please note that there no expected long term benefits of this study.
The purpose of the first part of this research study is to determine the effects of active transcutaneous spinal cord stimulation (TSCS) targeted for blood pressure (BP) control on exercise endurance time and heart rate (HR) recovery time during an arm cycle test. The results will help guide experimental studies aimed at improving exercise, rehabilitation, health, and longevity in the SCI population. If the participant chooses to participate in part one of this study, the participant will be asked to visit the laboratory for 2 visits that take about 3-4 hours each.
The purpose of part two of this study is to compare the effects of electricity being delivered through surface electrodes (sticky pads on the participants skin), called active transcutaneous spinal cord stimulation (TSCS), compared to sham TSCS (sticky pads with electricity initially turned on but then turned off) on the participants ability to 1) keep the participants body temperature stable and 2) feel comfortable, while in a cool environment (cool room at 64° F) for 90 minutes. The investigators will assess the participant thermal sensation by asking the participant if overall they feel cold, cool, neutral, warm, or hot and their comfort level by asking the participant to grade their thermal comfort (how comfortable or how uncomfortable they feel) when the participant is seated in a thermoneutral room (80° F) and again in the cool room with active TSCS compared to the cool room with sham TSCS. The results will help guide experimental studies aimed at improving health and longevity in the population with SCI. If the participant chooses to participate in this study, there will be 2 study visits that last about 3-4 hours each.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcutaneous Spinal Cord Stimulation | Experimental | The transcutaneous spinal cord stimulation used in this experiment is specific to each participant as determined in a previous study. Possible parameters include biphasic or monophasic, Russian or Nonrussian, a variety of pulse widths, and location of stimulation (T7-8, T9-10,- T11-12, L1-2). The amplitude of the stimulation also depends on the results of the mapping study. This stimulation will be delivered 30 minutes at a time. |
|
| Sham Transcutaneous Spinal Cord Stimulation | Sham Comparator | The sham stimulation will follow the above parameters but will only be delivered for a minute rather than the full 30 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous Spinal Cord Stimulation (TSCS) | Other | This is electrical stimulation delivered to the spinal cord through the skin and tissue using a cathode electrode to deliver the stimulation and anode electrodes to ground the circuit. |
| Measure | Description | Time Frame |
|---|---|---|
| Exercise Endurance Time | Total time (minutes) the participant is able to exercise during the submaximal arm cycle ergometry test. | During procedures (30 minutes) |
| Recovery Heart Rate | Total time (minutes) for heart rate to return to baseline levels after submaximal exertion. | During procedures (60 minutes) |
| Tcore | This outcome measure is measured in degrees Celsius. | During procedures (90 minutes) |
| Thermal Comfort | Feeling of comfort from: +3 (very comfortable) to -3 (very uncomfortable). | During procedures (90 minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| Workload | This outcome is measured in Watts (highest watt obtained) | End of exercise (30 minutes) |
| Rate of Perceived Exhaustion | This is measured on the Borg scale (06-20) higher number = harder perceived exertion |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Matthew T Maher, MS | Contact | (718) 584-9000 | 1706 | Matthew.Maher@va.gov |
| Fiona E Fox, BS | Contact | (718) 584-9000 | 3128 | fefox16@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Jill M Wecht, EdD | James J. Peters Veterans Affairs Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| James J Peters VAMC | Recruiting | The Bronx | New York | 10468 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007024 | Hypotension, Orthostatic |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D054971 | Orthostatic Intolerance |
| D054969 | Primary Dysautonomias |
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
The participant will not know whether or not they are receiving spinal stimulation at any given session
|
| Sham Transcutaneous Spinal Cord Stimulation | Other | This is designed to appear like transcutaneous spinal cord stimulation without actually delivering the stimulation. |
|
|
| End of exercise (30 minutes) |
| D007022 | Hypotension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001519 | Behavior |