A demographic profile of new traumatic spinal cord injuries: change and stability over 30 years.
Amie B Jackson, Marcel Dijkers, Michael J Devivo...
https://pubmed.ncbi.nlm.nih.gov/15520968Actively Recruiting
Phase Not Applicable
Age: 19Years - 65Years
All Genders
ID06587841
Noninvasive Spinal Cord Neuromodulation to Improve Lower Urinary Tract Function After Spinal Cord Injury in Ukrainian War Veterans
Led by University of British Columbia · Updated on 2026-02-27
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of British Columbia
Lead Sponsor
U
United States Department of Defense
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of non-invasive transcutaneous spinal cord stimulation (TSCS) to improve lower urinary tract, bowel, sexual, and cardiovascular function, as well as reduce spasticity, in adults with subacute and chronic spinal cord injury (SCI). This Phase II clinical trial aims to understand how TSCS impacts quality of life and bladder function in individuals with SCI at spinal segments C5-T10. The study includes participants with motor-complete SCI and documented impaired bladder function. The investigational device, SCONE174;, delivers electrical stimulation through the skin to activate spinal neural circuits related to pelvic floor and bladder control. Participants will be randomly assigned to one of two groups: Group 1 will receive therapeutic TSCS combined with conventional rehabilitation for 8 weeks, followed by an additional 8 weeks of TSCS therapy; Group 2 will initially receive sham stimulation with rehabilitation for 8 weeks and then switch to therapeutic TSCS for 8 weeks. Therapy sessions last one hour, three times a week, with rehabilitation 3-4 hours a day, five days a week. Each participant will attend 58 visits over approximately 33 weeks for assessments, therapy, and follow-up. Evaluations include bladder function, bowel movements, sexual health, cardiovascular monitoring, spasticity, and quality of life questionnaires. Researchers will measure changes in Neurogenic Bladder Symptom Score, voiding efficiency, and bowel movement timing, among others. Follow-up assessments will be conducted 8 weeks after treatment ends to assess lasting effects of TSCS.
CONDITIONS
Brief Title
Noninvasive Spinal Cord Stimulation for Early SCI
Who Can Participate
Age: 19Years - 65Years
All Genders
Eligibility Criteria
You may qualify if you...
- Be a resident of British Columbia with active medical coverage or Ukraine
- Age between 19 and 65 years at consent
- Subacute (3-6 months) or chronic (12+ months) spinal cord injury
- Motor-complete spinal cord injury (AIS A or B) at spinal segments C5 to T10
- Documented impaired lower urinary tract function
- Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during and for 28 days after the trial
- Sexually active males with female partners of childbearing potential must agree to use effective contraception during and for 28 days after the trial
- Provide informed consent
- Agree to attend all visits, follow bowel and urinary routines, and avoid new medications for bowel or urinary management without notifying the study investigator
You will not qualify if you...
- Clinically significant depression with suicidal thoughts or debilitating PTSD
- History of bladder augmentation, urinary stoma, or prior bladder surgery
- Signs of lower motor neuron injury such as conus medullaris or cauda equina injury
- OnabotulinumtoxinA injections in bladder or sphincter within 9 months before baseline
- Use of medication or treatments interfering with study outcomes
- Cognitive, psychological, or social issues preventing study completion
- Severe acute medical problems interfering with testing (e.g., advanced pressure ulcers, uncontrolled diabetes)
- Contraindications for TSCS including implanted cardiac pacemaker, metal implants in trunk or spine, intrathecal delivery systems, or implanted neuromodulators
- Medical conditions posing risk as judged by investigator
- Participation in other research that may affect study endpoints
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 8 to 16 weeks
Participants receive non-invasive transcutaneous spinal cord stimulation (TSCS) therapy to improve bladder function. Group 1 receives TSCS therapy for 16 weeks, and Group 2 receives sham stimulation for 8 weeks followed by 8 weeks of TSCS therapy.
Three visits per week, 1 hour per session, for up to 16 weeks
Follow-up
Duration - 8 weeks
Participants are assessed for persisting effects of TSCS after stopping therapy, including bladder, bowel, sexual function, and quality of life assessments.
1 follow-up visit after cessation of treatment
Trial Site Locations
Total: 1 location
1
Blusson Spinal Cord Centre
Vancouver, British Columbia, Canada, V5Z 1M9
Actively Recruiting
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Research Team
A
Andrea Maharaj, BSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Direct health care costs after traumatic spinal cord injury.
Donna M Dryden, L Duncan Saunders, Phillip Jacobs...
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Giuseppe Minervini, Rocco Franco, Maria Maddalena Marrapodi...
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Kim D Anderson
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Tracey L Wheeler, Bowel and Bladder Workshop Participants, William de Groat...
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David J Strauss, Michael J Devivo, David R Paculdo...
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E Garshick, A Kelley, S A Cohen...
https://pubmed.ncbi.nlm.nih.gov/15711609The Economic Burden of Autonomic Dysreflexia during Hospitalization for Individuals with Spinal Cord Injury.
Jordan W Squair, Barry A B White, Grace I Bravo...
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