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

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.

Study Overview

• Status: Recruiting
• Conditions: Spinal Cord Injury; Spinal Cord Injuries (SCI); Spinal Injury
• Intervention / Treatment: Other: Transcutaneous spinal electrical stimulation (TSES)

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kristine C Cowley, PhD; Phone Number: +1 204-789-3305; Email: kristine.cowley@umanitoba.ca
• Study Contact Backup: Name: Rodrigo Villar, PhD; Phone Number: +1-204-474-8590; Email: rodrigo.villar@umanitoba.ca

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E 0J9
      • Recruiting
      • University of Manitoba
      • Contact: Kristine Cowley, PhD; Phone Number: +1-204-789-3305; Email: kristine.cowley@umanitoba.ca
      • Principal Investigator: Kristine Cowley, PhD
      • Principal Investigator: Rodrigo Villar, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Upper body exercise in participants with tetraplegia; TSES during peak and steady state exercise in those with tetraplegia	Other: 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: Upper body exercise in participants with paraplegia; TSES during peak and steady state exercise in those with paraplegia	Other: 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: Upper body exercise in reference control participants; TSES during peak and steady state exercise in reference controls	Other: 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; Does TSES alter time to fatigue during NMES-evoked rhythmic lower limb exercise?	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle tissue oxygen saturation levels	Does TSES alter muscle tissue oxygen saturation levels during exercise, expressed as a percentage.	Oxygen saturation levels will be assessed during study visits lasting between 1 and 2.5 hours.

Collaborators and Investigators

• Sponsor: University of Manitoba
• Investigators: Principal Investigator: Kristine Cowley, Phd, University of Manitoba; Principal Investigator: Rodrigo Villar, PhD, University of Manitoba

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: May 29, 2026
• First Submitted That Met QC Criteria: July 2, 2026
• First Posted (Actual): July 9, 2026

Study Record Updates

• Last Update Posted (Actual): July 9, 2026
• Last Update Submitted That Met QC Criteria: July 2, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: exercise; obesity; cardiovascular disease; autonomic nervous system; spinal cord injury; sympathetic nervous system; arm ergometry
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Nutrition Disorders; Overnutrition; Body Weight; Overweight; Trauma, Nervous System; Spinal Cord Diseases; Back Injuries; Pathological Conditions, Signs and Symptoms; Behavior; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Cardiovascular Diseases; Spinal Cord Injuries; Spinal Injuries; Motor Activity
• Other Study ID Numbers: HS26003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: To maintain participant confidentiality

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No