Transcutaneous spinal electrical stimulation (TSES): TSES will typically involve constant current rectangular pulse bipolar stimulation delivered at 20 Hz with stimulation durations of 900 microseconds delivered at or slightly above motor threshold.
Study summary
Our overall objective is to decrease the prevalence of multiple sedentary-related diseases that are secondary consequences of spinal cord injury (SCI). SCI affects motor, sensory and autonomic systems and can cause very limited exercise capacity which then leads to very high rates of obesity, metabolic syndrome, type II diabetes and cardiovascular disease.
This randomized controlled study aims to determine whether and how transcutaneous spinal electrical stimulation (TSES) alters acute (immediate) exercise responses in people living with SCI. Exercise responses will be tested during incremental tests to fatigue, and during steady state tests. Testing will occur over several study visits and results will be compared within each individual as well as between groups (tetraplegia and paraplegia) and to a group of reference controls. A number of outcomes will be monitored, including whole-body metabolic responses using a metabolic cart, muscle responses using EMG sensors and muscle oxygenation using near infrared spectroscopy (NIRS) sensors, time to fatigue, power output, as well as perceptions about fatigue and effort.
The findings of this study are expected to provide evidence regarding whether and how TSES might improve acute exercise responses in people living with SCI.
Eligibility
Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
Accepted
Inclusion Criteria:
* traumatic or non-traumatic spinal cord injury
* Spinal cord injury of at least one year duration, C5 or lower, AIS A - D
* medically stable and healthy enough to engage in and complete exercise requirements
* willing and able to complete the exercise protocols and testing requirements
* able to understand and follow written and verbal instructions from study staff
* able to communicate with study staff about their exercise capabilities and preferences
Exclusion Criteria:
* current serious injury (ies) of the upper extremities
* known cardiovascular disease
* unsatisfactory results of EKG screening
* implanted electronic cardiac devices (e.g., pacemaker, defibrillator, etc.)
* current pressure ulcer(s)
* morbid obesity
* known thyroid dysfunction
* current cancer
* current uncontrolled high blood pressure
* uncontrolled epilepsy
* current deep vein thrombosis
* ventilator dependency
* cognitive impairment
Primary outcome measure(s)
Oxygen uptake — During individual study visits lasting between 1 and 2.5 hours Oxygen uptake, in mL/min
Perceived Exertion — Tested intermittently during individual voluntary exercise study visits lasting between 1 and 2.5 hours Ratings of perceived exertion, on a Borg scale of 6 to 20 with 6 being resting to 20 which is very very hard.
Time to fatigue during incremental exercise tests to fatigue — Time to fatigue will be monitored during study visits lasting between 1 and 2.5 hours. Does TSES alter time to fatigue during NMES-evoked rhythmic lower limb exercise, measured in seconds.
Heart rate — During exercise testing study visits, lasting between 1 and 3 hours Heart rate, beats per minute
Power output — During exercise in study visits lasting 1 to 3 hours. Watts
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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