NCT07692191 Transcutaneous Spinal Electrical Stimulation to Improve Exercise Function After Spinal Cord Injury.
| NCT ID | NCT07692191 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Manitoba |
| Condition | Spinal Cord Injuries (SCI) |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-06-10 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2024-06-10 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Kristine Cowley, Phd
PRINCIPAL INVESTIGATOR
University of Manitoba
Frequently Asked Questions
Who can join the NCT07692191 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Spinal Cord Injuries (SCI). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07692191 currently recruiting?
Yes, NCT07692191 is actively recruiting participants. Contact the research team at kristine.cowley@umanitoba.ca for enrollment information.
Where is the NCT07692191 trial being conducted?
This trial is being conducted at Winnipeg, Canada.
Who is sponsoring the NCT07692191 clinical trial?
NCT07692191 is sponsored by University of Manitoba. The principal investigator is Kristine Cowley, Phd at University of Manitoba. The trial plans to enroll 40 participants.