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Transcutaneous Spinal Electrical Stimulation to Improve Exercise Function After Spinal Cord Injury.

Transcutaneous Spinal Electrical Stimulation to Improve Exercise Function After Spinal Cord Injury.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07692191
Enrollment
40
Registered
2026-07-09
Start date
2024-06-10
Completion date
2026-10-01
Last updated
2026-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Cord Injuries (SCI), Spinal Cord Injury, Spinal Injury

Keywords

exercise, spinal cord injury, sympathetic nervous system, autonomic nervous system, arm ergometry, obesity, cardiovascular disease

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.

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: 1. Comparing peak incremental tests to voluntary upper body exercise fatigue with or without TSES. 2. Comparing steady state exercise responses performed at 40-45% peak power output with or without TSES. 3. 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.

Interventions

OTHERTranscutaneous 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.

Sponsors

University of Manitoba
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Oxygen uptakeDuring individual study visits lasting between 1 and 2.5 hoursOxygen uptake, in mL/min
Perceived ExertionTested intermittently during individual voluntary exercise study visits lasting between 1 and 2.5 hoursRatings 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 fatigueTime 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 rateDuring exercise testing study visits, lasting between 1 and 3 hoursHeart rate, beats per minute
Power outputDuring exercise in study visits lasting 1 to 3 hours.Watts

Secondary

MeasureTime frameDescription
Muscle tissue oxygen saturation levelsOxygen saturation levels will be assessed during study visits lasting between 1 and 2.5 hours.Does TSES alter muscle tissue oxygen saturation levels during exercise, expressed as a percentage.

Countries

Canada

Contacts

CONTACTKristine C Cowley, PhD
kristine.cowley@umanitoba.ca+1 204-789-3305
CONTACTRodrigo Villar, PhD
rodrigo.villar@umanitoba.ca+1-204-474-8590
PRINCIPAL_INVESTIGATORKristine Cowley, Phd

University of Manitoba

PRINCIPAL_INVESTIGATORRodrigo Villar, PhD

University of Manitoba

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 10, 2026