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

NCT07692191 | Recruiting

• 1 other identifier: HS26003
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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 Injury; Spinal Cord Injury

Keywords

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

Outcome Measures

Primary Outcomes (5)

• Oxygen uptake

  Oxygen uptake, in mL/min

  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.

  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 to fatigue will be monitored during study visits lasting between 1 and 2.5 hours.

• Heart rate

  Heart rate, beats per minute

  During exercise testing study visits, lasting between 1 and 3 hours

• Power output

  Watts

  During exercise in study visits lasting 1 to 3 hours.

Secondary Outcomes (1)

• Muscle tissue oxygen saturation levels

  Oxygen saturation levels will be assessed during study visits lasting between 1 and 2.5 hours.

Study Arms (4)

Upper body exercise in participants with tetraplegia

OTHER

TSES during peak and steady state exercise in those with tetraplegia

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

Other: Transcutaneous spinal electrical stimulation (TSES)

Upper body exercise in reference control participants

OTHER

TSES during peak and steady state exercise in reference controls

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?

Other: Transcutaneous spinal electrical stimulation (TSES)

Interventions

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.

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

University of Manitoba

Winnipeg, Manitoba, R3E 0J9, Canada

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries; Spinal Injuries; Motor Activity; Obesity; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Back Injuries; Behavior; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kristine Cowley, Phd

  University of Manitoba

  PRINCIPAL INVESTIGATOR

• Rodrigo Villar, PhD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristine C Cowley, PhD

CONTACT

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

Rodrigo Villar, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: May 29, 2026
• First Posted: July 9, 2026
• Study Start: June 10, 2024
• Primary Completion: August 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: July 9, 2026

Record last verified: 2026-05

Locations

CA (1)