Recruiting

Spinal Cord Stimulation

Sponsor:

University of British Columbia

Code:

NCT06587841

Conditions

Spinal Cord Injuries

Bowel Dysfunction

Sexual Dysfunction

Autonomic Dysfunction

Urologic Disorders

Eligibility Criteria

Sex: All

Age: 19 - 65

Healthy Volunteers: Not accepted

Interventions

Spinal COrd NEuromodulation™ (SCONE™) for transcutaneous spinal cord stimulation (TSCS)

Study Details

Brief 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 hour per session) in conjunction with conventional rehabilitation (3-4 hours per day; 5 days per week). G2 will receive 8 weeks of sham stimulation in conjunction with conventional rehabilitation. After 8 weeks, G2 will cross over and receive therapeutic TSCS for 8 weeks, whereas G1 will continue to receive TSCS therapy for another 8 weeks, for a total of 16 weeks. Eligible participants enrolled into the study will attend fifty eight (58) visits for assessments, therapy, and follow-up. The expected duration of study participation for each participant will be 33 weeks.

Conditions

Spinal Cord Injuries

Bowel Dysfunction

Sexual Dysfunction

Autonomic Dysfunction

Urologic Disorders

Study ID

NCT06587841

Start date

Oct 1, 2024

Status verified date

Feb, 2026

Completion date

Oct 1, 2027

Anticipated

Primary completion date

Oct 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19 - 65

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Group 1 Treatment

TSCS at or between cervical spinal segment 5 (C5) and thoracic spinal segment 10 (T10) at Intervention Phases 1 and 2, 8 weeks each.

sham comparator: Group 2 Sham

TSCS at or between C5 and T10 at Intervention Phase 2; 8 weeks.

Interventions

Spinal COrd NEuromodulation™ (SCONE™) for transcutaneous spinal cord stimulation (TSCS)

The SCONE™ class II investigational device is a non-invasive central nervous system (CNS) stimulator (electrical continence device) designed to provide transcutaneous spinal cord stimulation for the improvement of symptoms of bladder dysfunction associated with centrally-mediated NLUTD.

Primary outcome measure

  • Change in Neurogenic Bladder Symptom Score (NBSS) [ Time Frame: At baseline; At 8 weeks after treatment vs. sham; Following 16 weeks of stimulation; At 8 weeks after stopping stimulation ]

Central Contacts and Locations

Central contacts

Locations

Blusson Spinal Cord Centre

Recruiting

Vancouver, British Columbia, Canada, V5Z 1M9

Contacts

Principal Investigator:

Andrei Krassioukov, MD,PhD,FRCPC

More Information

Sponsor

University of British Columbia

Last update posted

Feb 27, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of British Columbia on 2026-02-27.