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Recruiting NCT05369520

NCT05369520 Non-invasive Spinal Cord Stimulation for Recovery of Autonomic Function After Spinal Cord Injury

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Clinical Trial Summary
NCT ID NCT05369520
Status Recruiting
Phase
Sponsor University of British Columbia
Condition Spinal Cord Injury
Study Type INTERVENTIONAL
Enrollment 30 participants
Start Date 2023-10-03
Primary Completion 2026-10

Trial Parameters

Condition Spinal Cord Injury
Sponsor University of British Columbia
Study Type INTERVENTIONAL
Phase N/A
Enrollment 30
Sex ALL
Min Age 19 Years
Max Age 60 Years
Start Date 2023-10-03
Completion 2026-10
Interventions
TESCoN or SCONE device - Thoracic stimulationTESCoN or SCONE device - Lumbosacral stimulation

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Brief 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 Criteria

Inclusion Criteria: 1. Resident of British Columbia, Canada with active provincial medical services plan. 2. Male or female, 19-60 years of age. 3. Chronic traumatic SCI (non-progressive, with complete motor paralysis) at or above the T6 spinal segment. 4. \>1-year post injury, at least 6 months from any spinal surgery. 5. American Spinal Injury Association Impairment Scale (AIS) A, B. 6. Stable management of spinal cord related clinical issues (i.e., spasticity management). 7. Experience bladder, or bowel, or sexual dysfunction. 8. No painful musculoskeletal dysfunction, unhealed fracture, pressure sore, or active infection that may interfere with testing. 9. For women of childbearing potential, not intending to become pregnant, currently pregnant, or lactating. The following conditions apply: 1. 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 out

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