Noninvasive Spinal Cord Stimulation for Early SCI

NCT06587841 | Recruiting DMC

• 2 other identifiers: H24-00284CDMRP-SC230030
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in Neurogenic Bladder Symptom Score (NBSS)

  Change in Neurogenic Bladder Symptom Score (NBSS) by 10-points at 8 weeks of therapy. The NBSS is a comprehensive and validated survey that quantifies symptoms of neurogenic lower urinary tract dysfunction (NLUTD). A minimum change of 5 points on the NBSS demonstrates clinically meaningful improvement for this patient population as established in the literature.

  At baseline; At 8 weeks after treatment vs. sham; Following 16 weeks of stimulation; At 8 weeks after stopping stimulation

Secondary Outcomes (2)

• Mean change in voiding efficacy by at least 50%

  At baseline; At 8 weeks after treatment vs. sham; Following 16 weeks of stimulation; At 8 weeks after stopping stimulation

• Mean change in time needed for bowel movement (TNFBM) by at least 50%

  At baseline; At 8 weeks after treatment vs. sham; Following 16 weeks of stimulation; At 8 weeks after stopping stimulation

Study Arms (2)

Group 1 Treatment

EXPERIMENTAL

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

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

Group 2 Sham

SHAM COMPARATOR

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

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

Interventions

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

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.

Group 1 Treatment; Group 2 Sham

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A participant must meet all of the following criteria in order to be eligible to participate:
• 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
• Subacute (time since injury 3-6 months) or chronic (time since injury 12+ months) SCI
• ASIA Impairment Scale (AIS) A or B at spinal segments C5-T10
• Documented impaired LUT function
• 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.
• 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.
• Must provide informed consent.
• 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.

You may not qualify if:

• A participant who meets any of the following criteria will be ineligible to participate:
• 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.
• History of bladder augmentation or continent or incontinent urinary stoma or prior bladder surgery.
• Exhibits signs of lower motor neuron injury (i.e., concomitant conus medullaris/cauda equina injury).
• History of intradetrusor or intrasphincter onabotulinumtoxinA injections within 9 months of baseline visit.
• Concurrent use of any medication or treatment that in the opinion of the investigator interferes with study outcomes.
• 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
• Presence of severe acute medical issues that interfere with testing (e.g., stage 3/4 pressure ulcers, uncontrolled diabetes).
• Contraindications for TSCS, such as:
• 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
• Medical condition that may put the participant at risk as determined by the investigator.
• Participation in or plans to participate in another research study that may interfere with the study endpoints.

Sponsors & Collaborators

• University of British Columbia: lead
• United States Department of Defense: collaborator
• Congressionally Directed Medical Research Programs: collaborator
• Rivne Regional War Veterans Hospital, Spinal Cord Injury Rehabilitation Center: collaborator

Study Sites (1)

Blusson Spinal Cord Centre

Vancouver, British Columbia, V5Z 1M9, Canada

RECRUITING

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MeSH Terms

Conditions

Spinal Cord Injuries; Intestinal Diseases; Sexual Dysfunction, Physiological; Primary Dysautonomias; Urologic Diseases

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Gastrointestinal Diseases; Digestive System Diseases; Genital Diseases; Urogenital Diseases; Autonomic Nervous System Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Male Urogenital Diseases

Study Officials

• Andrei Krassioukov, MD,PhD,FRCPC

  The University of British Columbia, International Collaboration on Repair Discoveries (ICORD)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Maharaj, BSc

CONTACT

604.675-8856; amaharaj@icord.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: single-blinded, sham-controlled clinical trial
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Professor in Physical Medicine and Rehabilitation

Model Details: * Intervention Phase 1 (stimulation sessions) - 8 weeks: Participants will be randomized into one of two groups and be blinded to treatment assignment: Group 1 (treatment condition) will receive TSCS for 1 hour, 3 times/week; Group 2 (sham condition) will receive sham stimulation for 1 hour, 3 times/week. * Intervention Phase 2 (stimulation sessions) -8 weeks: Group 1 will continue to receive TSCS for 1 hour, 3 times/week, and Group 2 will switch from sham stimulation to TSCS for 1 hour, 3 times/week.

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: September 19, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Data will be available upon full-text print publication in a peer-reviewed journal, for a duration of at least 10 years.
• Access Criteria: Online access or e-mail request to the corresponding author from an established scientific investigator.

Locations

CA (1)