NCT05369520

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of British Columbia · Academic / Other
• Sex: All
• Age: 19 Years – 60 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This is a pilot clinical trial to explore the efficacy of TCSCS (proof-of-concept) in mitigating crucial autonomic dysfunctions that impact the health-related quality of life of individuals with SCI. A total of 30 eligible participants will be recruited and attend forty-two visits. All experiments will be performed at ICORD (Primary site) and the Brenda and David McLean Integrated Spine Clinic (SCI clinic), with the exception of anorectal manometry testing conducted at the Gastroenterology Clinic, St Paul's Hospital (GI clinic). Following completion of screening and signing informed consent forms (visit 1), participants will undergo spatiotemporal mapping of spinal cord segments known to be involved in blood pressure, lower urinary tract and bowel control (visit 2). Following mapping, all individuals will undergo baseline functional assessments with and without TCSCS during 5 visits (visits 3-7), over a period of 4 weeks. To minimize the order effect, the functional assessments will be performed in a randomized order. Following baseline assessments, using a randomized counter-balanced approach, individuals will be allocated in two distinct pathways; the participants in Groups 1 and 2 will receive 8 weeks of TCSCS (3 times/week) at either mid/low thoracic or lumbosacral spinal cord levels respectively (visits 8- 31). Following long-term TCSCS, participants will undergo functional assessments during 5 visits (visits 32- 36) over a period of 4 weeks. In order to evaluate the persistent effects of TCSCS, all assessments will be repeated 8 weeks after cessation of the therapy.

Conditions

• Spinal Cord Injury
• Autonomic Dysfunction
• Sexual Dysfunction
• Neurogenic Bladder Dysfunction
• Neurogenic Bowel Dysfunction
• Autonomic Dysreflexia
• Orthostatic Hypotension

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-10-03
• Primary completion: 2026-10-01
• Completion: 2027-10-01
• First posted: 2022-05-11
• Last updated: 2025-12-08

Locations

2 sites across 1 country: Canada

Regulatory

• FDA-regulated device study