Transcutaneous Spinal Electrical Stimulation to Improve Exercise Function After Spinal Cord Injury.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity of Manitoba
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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.)
Trial design
Design model
Crossover
Treatments tested in this trial
Transcutaneous spinal electrical stimulation (TSES)
Other interventionTSES 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.
Treatment groups
40 Participants
are divided into 4 treatment groupsGroup A: Upper body exercise in participants with tetraplegiaOther 1 intervention
Group B: Upper body exercise in participants with paraplegiaOther 1 intervention
Group C: Upper body exercise in reference control participantsOther 1 intervention
Group D: Rhythmic lower limb neuromuscular electrical stimulation evoked exerciseOther 1 intervention
Trial outcomes
Primary outcomes
1
Oxygen uptake
Oxygen uptake, in mL/min
Time frame
During individual study visits lasting between 1 and 2.5 hours2
Perceived Exertion
Ratings of perceived exertion, on a Borg scale of 6 to 20 with 6 being resting to 20 which is very very hard.
Time frame
Tested intermittently during individual voluntary exercise study visits lasting between 1 and 2.5 hours3
Time to fatigue during incremental exercise tests to fatigue
Does TSES alter time to fatigue during NMES-evoked rhythmic lower limb exercise, measured in seconds.
Time frame
Time to fatigue will be monitored during study visits lasting between 1 and 2.5 hours.4
Heart rate
Heart rate, beats per minute
Time frame
During exercise testing study visits, lasting between 1 and 3 hoursSecondary outcomes
1
Muscle tissue oxygen saturation levels
Does TSES alter muscle tissue oxygen saturation levels during exercise, expressed as a percentage.
Time frame
Oxygen saturation levels will be assessed during study visits lasting between 1 and 2.5 hours.Sponsors and contacts
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Source ClinicalTrials.gov