NCT04726059 Motor & Autonomic Concomitant Health Improvements With Neuromodulation & Exercise Training: An SCI RCT
| NCT ID | NCT04726059 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of British Columbia |
| Condition | Spinal Cord Injuries |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2022-07-22 |
| Primary Completion | 2024-12 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
Spinal cord injury (SCI) disrupts many aspects of life, including the loss of volitional movement and involuntary control of bodily functions; both crucial functional recovery priorities for this population. Mobility impairments and secondary complications limit an individual's ability to exercise, a behavior known to have wide-ranging functional and health benefits. This trial will investigate whether activity-based therapy (ABT), using body-weight-supported treadmill training (BWSTT), can change the strength of signals from the brain that control volitional movement, leading to improvements in seated balance as well as other important involuntary bodily (i.e. cardiovascular, urinary tract, bowel and sexual) functions. The investigators aim to determine whether these improvements can be augmented with the addition of non-invasive transcutaneous spinal cord stimulation (TSCS). This therapy has been shown to re-awaken dormant spinal circuits. In this randomized controlled trial, TSCS with ABT, using BWSTT (three sessions/week for twelve weeks), will be compared to ABT+SHAM in individuals with chronic motor-complete spinal cord injury (SCI). Those in the ABT+SHAM group will be given the option to complete an ABT+TSCS open-label follow-up. Before and after training, the following outcomes will be assessed by validated methods: corticospinal excitability, motor function, and seated balance (Hypothesis 1 - Motor Function); severity and frequency of blood pressure instability, urinary tract, bowel, and sexual dysfunctions (Hypothesis 2 - Autonomic Functions); and general health (Hypothesis 3 - Quality of Life). This collaborative project is between consumers with SCI and clinicians/scientists with expertise in SCI care (kinesiologists, physiotherapists, physiatrists, sexual health clinicians). Compared to ABT alone, the investigators anticipate that ABT+TSCS will result in superior improvements in motor and autonomic functions in individuals with SCI.
Eligibility Criteria
INCLUSION CRITERIA A participant must meet all of the following criteria in order to be eligible for inclusion: * Resident of British Columbia, Canada with active provincial medical services plan * Male or female, 18-60 years of age * Chronic traumatic SCI (non-progressive, with complete motor paralysis) at or above the T6 spinal segment * At least 1-year post injury, at least 6 months from any spinal surgery * American Spinal Injury Association Impairment Scale (AIS) A, B * Able to tolerate an upright posture for 30 minutes (with or without breaks) * Willing and able to comply with all clinic visits and study-related procedures * Able to understand and complete study-related questionnaires (must be able to understand and speak English or have access to an appropriate interpreter as judged by the investigator) * No painful musculoskeletal dysfunction, unhealed fracture, pressure sore, or active infection that may interfere with testing activities * Stable management of spinal cord rela