Noninvasive spinal cord stimulation for recovery after spinal cord injury
Noninvasive Spinal Cord Neuromodulation to Improve Lower Urinary Tract Function After Spinal Cord Injury in Ukrainian War Veterans
This study is testing a new non-invasive treatment to see if it can help improve bladder, bowel, sexual, and heart functions in people who have had a spinal cord injury for a few months.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 19 Years to 65 Years |
| Sex | All |
| Sponsor | University of British Columbia Academic / other |
| Locations | 1 site (Vancouver, British Columbia) |
| Trial ID | NCT06587841 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the safety and efficacy of non-invasive transcutaneous spinal cord stimulation (TSCS) to improve bladder, bowel, sexual, and cardiovascular functions in individuals with subacute spinal cord injuries (3-6 months post-injury). Participants will be randomly assigned to receive either therapeutic TSCS or sham stimulation alongside conventional rehabilitation. The study aims to assess both immediate and long-term effects of TSCS on lower urinary tract function and overall quality of life. Conducted at two sites in Canada and Ukraine, the trial will enroll up to 60 subjects.
Who should consider this trial
Good fit: Ideal candidates are adults aged 19 to 65 with subacute spinal cord injuries and documented impaired lower urinary tract function.
Not a fit: Patients with chronic spinal cord injuries or those outside the specified age range may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly enhance recovery and quality of life for patients with spinal cord injuries.
How similar studies have performed: Other studies have shown promise with similar non-invasive stimulation approaches, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
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 use adequate contraception during the period of the trial and for at least 28 days after completion of treatment. Effective contraception includes abstinence.
6. Sexually active males with female partners of childbearing potential must agree to use effective contraception during the period of the trial and for at least 28 days after completion of treatment.
7. Must provide informed consent.
8. Agrees to comply with all planned visits and assessments, adhere with established bowel and LUT routines and refrain from initiation of new medications for bowel and LUT management without notifying the Principal Investigator of this study.
Exclusion Criteria:
* A participant who meets any of the following criteria will be ineligible to participate:
1. Clinically significant depression with thoughts of suicidal ideation (PHQ-9 total score above 20) or debilitating PTSD (PCL-5 total score above) or as judged by the investigator.
2. History of bladder augmentation or continent or incontinent urinary stoma or prior bladder surgery.
3. Exhibits signs of lower motor neuron injury (i.e., concomitant conus medullaris/cauda equina injury).
4. History of intradetrusor or intrasphincter onabotulinumtoxinA injections within 9 months of baseline visit.
5. Concurrent use of any medication or treatment that in the opinion of the investigator interferes with study outcomes.
6. Presence of cognitive impairments, social/psychological problems, or other comorbid conditions that, in the opinion of the Investigator, will preclude them from participation and completion of the study
7. Presence of severe acute medical issues that interfere with testing (e.g., stage 3/4 pressure ulcers, uncontrolled diabetes).
8. Contraindications for TSCS, such as:
8.1. Implanted Cardiac pacemaker 8.2 Implanted metal in the trunk or spinal cord 8.3 Intrathecal delivery system (e.g., baclofen pump) 8.4 Implanted central or peripheral neuromodulator
9. Medical condition that may put the participant at risk as determined by the investigator.
10. Participation in or plans to participate in another research study that may interfere with the study endpoints.
Where this trial is running
Vancouver, British Columbia
- Blusson Spinal Cord Centre — Vancouver, British Columbia, Canada (Recruiting)
Study contacts
- Principal investigator: Andrei Krassioukov, MD,PhD,FRCPC — The University of British Columbia, International Collaboration on Repair Discoveries (ICORD)
- Study coordinator: Andrea Maharaj, BSc
- Email: amaharaj@icord.org
- Phone: 604.675-8856
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.