James J Peters VAMC
The Bronx, New York, 10468, United States
Location status: Recruiting
NCT Number: NCT05960448
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:
* What are the effects of active TSCS targeted for BP control on exercise endurance time and HR recovery during submaximal arm cycle ergometry (ACE) as compared to sham TSCS in participants with chronic, cervical SCI? * What are the effects of active TSCS on Tcore responses to cool ambient exposure and on subjective reporting of thermal comfort and thermal sensitivity as compared to sham TSCS.
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
The Bronx, New York, 10468, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: transcutaneous spinal stimulation (TSS)
This is designed to appear like transcutaneous spinal cord stimulation without actually delivering the stimulation.
Other names: Sham Transcutaneous Spinal Stimulation, Placebo Transcutaneous Spinal Stimulation, Placebo Transcutaneous Spinal Cord Stimulation
Time frame: During procedures (30 minutes)
Total time (minutes) the participant is able to exercise during the submaximal arm cycle ergometry test.
Time frame: During procedures (60 minutes)
Total time (minutes) for heart rate to return to baseline levels after submaximal exertion.
Time frame: During procedures (90 minutes)
This outcome measure is measured in degrees Celsius.
Time frame: During procedures (90 minutes)
Feeling of comfort from: +3 (very comfortable) to -3 (very uncomfortable).
Time frame: End of exercise (30 minutes)
This outcome is measured in Watts (highest watt obtained)
Time frame: End of exercise (30 minutes)
This is measured on the Borg scale (06-20) higher number = harder perceived exertion
Contact information is provided by the study sponsor or research team.
Fiona E Fox, BS
CONTACT
(718) 584-9000 ext. 3128
Matthew T Maher, MS
CONTACT
(718) 584-9000 ext. 1706
James J. Peters Veterans Affairs Medical Center
Fed
Autonomic Effects of Transcutaneous Spinal Cord Stimulation in Veterans With Spinal Cord Injury (SCI)
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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