Noninvasive Spinal Cord Stimulation for Early SCI
The investigators are looking to determine the safety and efficacy of non-invasive transcutaneous spinal cord stimulation (TSCS) in promoting recovery of lower urinary tract (LUT), bowel, sexual, and cardiovascular function, as well as spasticity in individuals with subacute and chronic SCI (time since injury 3-6 month
| Condition(s) | Spinal Cord Injuries, Bowel Dysfunction, Sexual Dysfunction, Autonomic Dysfunction, Urologic Disorders |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | The investigators are looking to determine the safety and efficacy of non-invasive transcutaneous spinal cord stimulation (TSCS) in promoting recovery of lower urinary tract (LUT), bowel, sexual, and cardiovascular function, as well as spasticity in individuals with subacute and chronic SCI (time since injury 3-6 months) and the impact on quality of life. The study will be conducted at two sites; site 1 in Canada and site 2 in the Ukraine. Up to 60 subjects will be enrolled; 10 adults at the ICORD, University of British Columbia (UBC), Vancouver, Canada site and 50 adults at the Rivne Regional War Veterans Hospital, Rivne, Ukraine. Eligible participants will be randomized (1:1 ratio) either to Group 1 (G1) or Group 2 (G2). G1 will receive therapeutic TSCS for 8 weeks (3 times per week; 1 h |
| Who can participate | Inclusion Criteria: * A participant must meet all of the following criteria in order to be eligible to participate: 1. Be a resident of either British Columbia (for Vancouver Site) with an active provincial medical service plan or Ukraine (for Ukraine Site) Age between 19 and 65 years at the time of consent 2. Subacute (time since injury 3-6 months) or chronic (time since injury 12+ months) SCI 3. ASIA Impairment Scale (AIS) A or B at spinal segments C5-T10 4. Documented impaired LUT function 5. Women of childbearing potential must not be intending to become pregnant, currently pregnant, or lactating. The following conditions apply: i. Women of childbearing potential must have a confirmed negative pregnancy test prior to the baseline visit. ii. Women of childbearing potential must agree to |
| Ages | 19 Years to 65 Years |
| Sex | All |
| Lead sponsor | University of British Columbia |
| Locations | Vancouver, British Columbia, Canada |
| Start date | 2024-10-01 |
| NCT ID | NCT06587841 |
| Official listing | https://clinicaltrials.gov/study/NCT06587841 |