Noninvasive Spinal Cord Stimulation for Early SCI

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

Interventions

DEVICE

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.

Sponsors & Collaborators

• United States Department of Defense

  collaborator FED

• Rivne Regional War Veterans Hospital, Spinal Cord Injury Rehabilitation Center

  collaborator UNKNOWN

• Congressionally Directed Medical Research Programs

  collaborator FED

• University of British Columbia

  lead OTHER

Principal Investigators

• Andrei Krassioukov, MD,PhD,FRCPC · The University of British Columbia, International Collaboration on Repair Discoveries (ICORD)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

19 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-10-01

Primary Completion

2027-10-01

Completion

2027-10-01

Countries

• Canada

Study Locations