Spinal Cord Injuries (SCI)NCT07692191
Transcutaneous Spinal Electrical Stimulation to Improve Exercise Function After Spinal Cord Injury.
A study testing Transcutaneous spinal electrical stimulation (TSES) in people with Spinal Cord Injuries (SCI) and Spinal Cord Injury, run by University of Manitoba at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries (SCI), Spinal Cord Injury, Spinal Injury
- What is being tested?
- Transcutaneous spinal electrical stimulation (TSES)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 10 Jun 2024to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- known thyroid dysfunction
- current cancer
- current uncontrolled high blood pressure
- uncontrolled epilepsy
- current deep vein thrombosis
- ventilator dependency
- cognitive impairment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University of Manitoba
Winnipeg, Manitoba, R3E 0J9
Kristine Cowley, PhD, +1-204-789-3305, kristine.cowley@umanitoba.ca
Kristine Cowley, PhD
About this study
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.
Read the detailed description
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:
- Comparing peak incremental tests to voluntary upper body exercise fatigue with or without TSES.
- Comparing steady state exercise responses performed at 40-45% peak power output with or without TSES.
- Comparing time to fatigue during neuromuscular electrical stimulation (NMES) evoked rhythmic leg contractions with or without TSES.
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.
- Being tested
- Transcutaneous spinal electrical stimulation (TSES)
- Keywords
- exercise, spinal cord injury, sympathetic nervous system, autonomic nervous system, arm ergometry, obesity, cardiovascular disease
- Medical subject headings
- Spinal Cord Injuries, Spinal Injuries, Motor Activity, Obesity, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous spinal electrical stimulation (TSES)Other
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 group | Role | What they receive |
|---|---|---|
| Upper body exercise in participants with tetraplegia | Other | TSES during peak and steady state exercise in those with tetraplegia Receives: Other: Transcutaneous spinal electrical stimulation (TSES) |
| Upper body exercise in participants with paraplegia | Other | TSES during peak and steady state exercise in those with paraplegia Receives: Other: Transcutaneous spinal electrical stimulation (TSES) |
| Upper body exercise in reference control participants | Other | TSES during peak and steady state exercise in reference controls Receives: Other: Transcutaneous spinal electrical stimulation (TSES) |
| Rhythmic lower limb neuromuscular electrical stimulation evoked exercise | Other | Does TSES alter time to fatigue during NMES-evoked rhythmic lower limb exercise? Receives: Other: Transcutaneous spinal electrical stimulation (TSES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen uptake
Oxygen uptake, in mL/min
Measured: 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.
Measured: 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.
Measured: Time to fatigue will be monitored during study visits lasting between 1 and 2.5 hours.
Heart rate
Heart rate, beats per minute
Measured: During exercise testing study visits, lasting between 1 and 3 hours
Power output
Watts
Measured: During exercise in study visits lasting 1 to 3 hours.
Secondary outcomes (1)
Muscle tissue oxygen saturation levels
Does TSES alter muscle tissue oxygen saturation levels during exercise, expressed as a percentage.
Measured: Oxygen saturation levels will be assessed during study visits lasting between 1 and 2.5 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start10 Jun 2024
- Primary completionAug 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord Injuries (SCI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will be assigned to one of two groups (tetraplegia or paraplegia) depending upon AIS assessment and then crossover testing will occur with or without TSES during tests of peak incremental exercise or steady-state exercise responses.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristine Cowley, University of Manitoba
- Investigators
- Kristine Cowley, Phd, Principal investigator, University of ManitobaRodrigo Villar, PhD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07692191
- Sponsor's protocol ID
- HS26003
- Status last verified
- May 2026
- First submitted
- 29 May 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: To maintain participant confidentiality
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Spinal Electrical Stimulation to Improve Exercise Function After Spinal Cord Injury.
- ClinicalTrials.gov ID
- NCT07692191
- Acronym / sponsor ID
- HS26003
- Keywords
- exercise, spinal cord injury, sympathetic nervous system, autonomic nervous system, arm ergometry, obesity, cardiovascular disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 10 Jun 2024 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 9 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Comparing peak incremental tests to voluntary upper body exercise fatigue with or without TSES.
- Comparing steady state exercise responses performed at 40-45% peak power output with or without TSES.
- Comparing time to fatigue during neuromuscular electrical stimulation (NMES) evoked rhythmic leg contractions with or without TSES.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- Participants will be assigned to one of two groups (tetraplegia or paraplegia) depending upon AIS assessment and then crossover testing will occur with or without TSES during tests of peak incremental exercise or steady-state exercise responses.
| Arm | Type | Receives |
|---|---|---|
| Upper body exercise in participants with tetraplegia | Other | Other: Transcutaneous spinal electrical stimulation (TSES)TSES during peak and steady state exercise in those with tetraplegia |
| Upper body exercise in participants with paraplegia | Other | Other: Transcutaneous spinal electrical stimulation (TSES)TSES during peak and steady state exercise in those with paraplegia |
| Upper body exercise in reference control participants | Other | Other: Transcutaneous spinal electrical stimulation (TSES)TSES during peak and steady state exercise in reference controls |
| Rhythmic lower limb neuromuscular electrical stimulation evoked exercise | Other | Other: Transcutaneous spinal electrical stimulation (TSES)Does TSES alter time to fatigue during NMES-evoked rhythmic lower limb exercise? |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Rhythmic lower limb neuromuscular electrical stimulation evoked exercise, Upper body exercise in participants with paraplegia, Upper body exercise in participants with tetraplegia, Upper body exercise in reference control participants |
Primary outcome
Oxygen uptake
Time frame: During individual study visits lasting between 1 and 2.5 hours
Oxygen uptake, in mL/min
Perceived Exertion
Time frame: 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 frame: 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
Time frame: During exercise testing study visits, lasting between 1 and 3 hours
Heart rate, beats per minute
Power output
Time frame: During exercise in study visits lasting 1 to 3 hours.
Watts
1 secondary outcome
Muscle tissue oxygen saturation levels
Time frame: Oxygen saturation levels will be assessed during study visits lasting between 1 and 2.5 hours.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: Undecided. To maintain participant confidentiality
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kristine Cowley, Phd principal investigator
University of Manitoba
Rodrigo Villar, PhD principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous spinal electrical stimulation (TSES) in people with Spinal Cord Injuries (SCI) and Spinal Cord Injury, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kristine C Cowley, PhD (+1 204-789-3305, kristine.cowley@umanitoba.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygen uptake (time frame: During individual study visits lasting between 1 and 2.5 hours). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.