Recruiting

TSES

Sponsor:

University of Manitoba

Code:

NCT07692191

Conditions

Spinal Cord Injuries (SCI)

Spinal Cord Injury

Spinal Injury

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

Interventions

Transcutaneous spinal electrical stimulation (TSES)

Study Details

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.

Conditions

Spinal Cord Injuries (SCI)

Spinal Cord Injury

Spinal Injury

Study ID

NCT07692191

Start date

Jun 10, 2024

Status verified date

May, 2026

Completion date

Oct, 2026

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

other: Upper body exercise in participants with tetraplegia

TSES during peak and steady state exercise in those with tetraplegia

other: Upper body exercise in participants with paraplegia

TSES during peak and steady state exercise in those with paraplegia

other: Upper body exercise in reference control participants

TSES during peak and steady state exercise in reference controls

other: Rhythmic lower limb neuromuscular electrical stimulation evoked exercise

Does TSES alter time to fatigue during NMES-evoked rhythmic lower limb exercise?

Interventions

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.

Primary outcome measure

  • Oxygen uptake [ Time Frame: During individual study visits lasting between 1 and 2.5 hours ]
  • Perceived Exertion [ 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 [ Time Frame: Time to fatigue will be monitored during study visits lasting between 1 and 2.5 hours. ]
  • Heart rate [ Time Frame: During exercise testing study visits, lasting between 1 and 3 hours ]
  • Power output [ Time Frame: During exercise in study visits lasting 1 to 3 hours. ]

Central Contacts and Locations

Central contacts

Kristine C Cowley, PhD

+1 204-789-3305kristine.cowley@umanitoba.ca

Rodrigo Villar, PhD

+1-204-474-8590rodrigo.villar@umanitoba.ca

Locations

University of Manitoba

Recruiting

Winnipeg, Manitoba, Canada, R3E 0J9

Contacts

Kristine Cowley, PhD

+1-204-789-3305kristine.cowley@umanitoba.ca

Principal Investigator:

Kristine Cowley, PhD

More Information

Sponsor

University of Manitoba

Last update posted

Jul 9, 2026

Last verified

May, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Manitoba on 2026-07-09.