Non-invasive Spinal Cord Stimulation for Recovery of Autonomic Function After Spinal Cord Injury
NCT05369520 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2025-12-08
Summary
This study is a pilot clinical trial to explore the efficacy of transcutaneous spinal cord stimulation (TCSCS) (proof-of-concept) in mitigating crucial autonomic dysfunctions that impact the health-related quality of life of individuals with spinal cord injury (SCI).
Conditions
- Spinal Cord Injury
- Autonomic Dysfunction
- Sexual Dysfunction
- Neurogenic Bladder Dysfunction
- Neurogenic Bowel Dysfunction
- Autonomic Dysreflexia
- Orthostatic Hypotension
Interventions
- DEVICE
-
TESCoN or SCONE device - Thoracic stimulation
TCSCS will be delivered using a non-invasive central nervous system stimulator (TESCoN or SCONE, SpineX Inc., CA, USA). The stimulation site will be over the thoracic spinal cord.
- DEVICE
-
TESCoN or SCONE device - Lumbosacral stimulation
TCSCS will be delivered using a non-invasive central nervous system stimulator (TESCoN or SCONE, SpineX Inc., CA, USA). The stimulation site will be over the lumbosacral spinal cord.
Sponsors & Collaborators
-
United States Department of Defense
collaborator FED -
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
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 19 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-10-03
- Primary Completion
- 2026-10-31
- Completion
- 2027-10-31
- FDA Device
- Yes
Countries
- Canada
Study Locations
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