An interventional study of Transcutaneous spinal electrical stimulation (TSES) in Spinal Cord Injuries (SCI), Spinal Cord Injury and Spinal Injury, sponsored by University of Manitoba. Recruiting at 1 site in Canada. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-09.
Sponsored by University of Manitoba · Not applicable, Interventional, and Basic science
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.
It is well understood that SCI causes motor paralysis and sensory loss. However, it is the loss of autonomic regulation that confers the greatest morbidity to those living with SCI. Impaired exercise responses, including limited peak HR, oxygen uptake, limited catecholamine related to impaired activation of spinal sympathetic autonomic systems. Depending upon level of injury, and these sub-optimal exercise responses, there are limited exercise training effects which then leads to a calorie excess and related weight gain, cardiovascular, skeletal muscle and metabolic deconditioning that eventually causes obesity, type II diabetes and cardiovascular disease.
These sedentary-related diseases likely result in large part, because of inadequate activation of these tissues with sufficient duration or intensity to result in training effects. Therefore, we are interested in identifying means to improve acute exercise responses, with an ultimate goal of improving training responses and reducing the incidence of and/or trajectory of developing these sedentary-related diseases in individuals with SCI.
TSES has recently emerged as a potential therapeutic method to improve exercise responses. In case studies it has been shown to increase peak responses and time to fatigue during arm ergometry exercise tests.
This study is designed as a prospective, single-center, randomized controlled trial to examine whether and how TSES might alter exercise responses in two groups of people with SCI (tetraplegia and paraplegia) and a reference control group from the general population. The study is designed to assess within individual and between-group responses for a variety of outcome measures during peak and steady-state exercise tests. Study visits occur over several weeks for each participant, according to each person's time and convenience availability.
Outcomes are assessed during exercise with and without TSES in the following 4 experimental conditions:
The primary hypothesis is that TSES will improve a variety of exercise outcomes under different experimental testing conditions and that those with tetraplegia will benefit most.
The results of this study are expected to contribute to whether and how TSES might alter acute exercise responses in those living with SCI.
The results of this study are expected to contribute to the evidence base regarding the effectiveness of TSES to alter peak and steady-state exercise responses in people with SCI and may support its integration into standard exercise training or competitive sport protocols for individuals with SCI.
Exclusion Criteria:
TSES during peak and steady state exercise in those with tetraplegia
Other: Transcutaneous spinal electrical stimulation (TSES)
TSES during peak and steady state exercise in those with paraplegia
Other: Transcutaneous spinal electrical stimulation (TSES)
TSES during peak and steady state exercise in reference controls
Other: Transcutaneous spinal electrical stimulation (TSES)
Does TSES alter time to fatigue during NMES-evoked rhythmic lower limb exercise?
Other: 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.
Oxygen uptake
Oxygen uptake, in mL/min
Time frame: During individual study visits lasting between 1 and 2.5 hours
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 hours
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.
Heart rate
Heart rate, beats per minute
Time frame: During exercise testing study visits, lasting between 1 and 3 hours
Power output
Watts
Time frame: During exercise in study visits lasting 1 to 3 hours.
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.
Plan to share: Undecided — To maintain participant confidentiality
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Manitoba