About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
You are above the age of 18 years old
You have an SCI between C3-T6
You have been injured longer than 1 year
You participated in a prior experiment "Targeted Transcutaneous Spinal Cord Stimulation to Restore Autonomic Cardiovascular Health in Individuals with Spinal Cord Injury"
Disqualifiers
You have a history of seizures
You have an acute illness or infection
You have diabetes
You have untreated thyroid disease
Trial design
Crossover
Treatments tested in this trial
Transcutaneous Spinal Cord Stimulation (TSCS)
Other interventionThis 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.
Sham Transcutaneous Spinal Cord Stimulation
Other interventionThis is designed to appear like transcutaneous spinal cord stimulation without actually delivering the stimulation.
Treatment groups
Trial outcomes
Primary outcomes
Exercise Endurance Time
Total time (minutes) the participant is able to exercise during the submaximal arm cycle ergometry test.
Recovery Heart Rate
Total time (minutes) for heart rate to return to baseline levels after submaximal exertion.
Tcore
This outcome measure is measured in degrees Celsius.
Thermal Comfort
Feeling of comfort from: +3 (very comfortable) to -3 (very uncomfortable).
Secondary outcomes
Workload
This outcome is measured in Watts (highest watt obtained)
Rate of Perceived Exhaustion
This is measured on the Borg scale (06-20) higher number = harder perceived exertion
Sponsors and contacts
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