Non-invasive Spinal Cord Stimulation for Recovery of Autonomic Function After Spinal Cord Injury: Moving From Mechanisms to Clinical Practice

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Maximum Age: 60
Healthy Volunteers: f
View:

• Resident of British Columbia, Canada with active provincial medical services plan.

• Male or female, 19-60 years of age.

• Chronic traumatic SCI (non-progressive, with complete motor paralysis) at or above the T6 spinal segment.

• \>1-year post injury, at least 6 months from any spinal surgery.

• American Spinal Injury Association Impairment Scale (AIS) A, B.

• Stable management of spinal cord related clinical issues (i.e., spasticity management).

• Experience bladder, or bowel, or sexual dysfunction.

• No painful musculoskeletal dysfunction, unhealed fracture, pressure sore, or active infection that may interfere with testing.

• For women of childbearing potential, not intending to become pregnant, currently pregnant, or lactating. The following conditions apply:

∙ A confirmed negative pregnancy test prior to the baseline visit. During the trial, all women of childbearing potential will undergo urine pregnancy tests at their monthly clinic visits as outlined in the schedule of events.

‣ Use adequate contraception, or complete abstinence from sexual activities, during the period of the trial and for at least 28 days after completion of treatment.

‣ If using combined hormonal contraception, a stable regimen during the period of the trial and for at least 28 days after completion of treatment.

⁃ For sexually active males with female partners of childbearing potential, use adequate contraception, or complete abstinence from sexual activities, during the period of the trial and for at least 28 days after completion of treatment.

⁃ Must provide informed consent.

⁃ Willing and able to comply with all clinic visits and study-related procedures.

⁃ Able to understand and complete study-related questionnaires (must be able to understand and speak English or have access to an appropriate interpreter as judged by the investigator).

Locations
Other Locations
Canada
Blusson Spinal Cord Centre
RECRUITING
Vancouver
St Paul's Hospital
RECRUITING
Vancouver
Contact Information
Primary
Andrea L. Maharaj, BSc
AMaharaj@icord.org
604-675-8856
Backup
Soshi Samejima, PhD
soshi@icord.org
604 675 8816
Time Frame
Start Date: 2023-10-03
Estimated Completion Date: 2027-10
Participants
Target number of participants: 30
Treatments
Experimental: Group 1 - Thoracic stimulation
Participants will receive 8 weeks TCSCS at the mid/low thoracic spinal cord levels.
Experimental: Group 2- Lumbosacral stimulation
Participants will receive 8 weeks TCSCS at the lumbosacral spinal cord levels.
Sponsors
Collaborators: United States Department of Defense, Congressionally Directed Medical Research Programs
Leads: University of British Columbia

This content was sourced from clinicaltrials.gov