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

Recruiting now · Not applicable

Conditions studied: Spinal Cord Injuries (SCI), Spinal Cord Injury, Spinal Injury

In brief

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.

Key facts

Study ID

NCT07692191

Run by

University of Manitoba

People needed

40

Starts

2024-06-10

Expected to finish

2026-10-01

Last updated by the study team

2026-07-09

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

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

Where it is running

• University of Manitoba — Winnipeg, Manitoba, Canada (enrolling)

Full record on ClinicalTrials.gov

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