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Transcutaneous Spinal Cord Stimulation Home Study
Sponsor: Michael Berger
Summary
The goal of this pilot clinical trial is to examine the safety and feasibility of SCONE as home based therapy for orthostatic hypotension and bowel dysfunction in individuals with spinal cord injury or multiple system atrophy. The main aims of the study are: * To establish a safe protocol for home-based transcutaneous spinal cord stimulation therapy at the research centre * To test the safety and feasibility of home-based transcutaneous spinal cord stimulation therapy on orthostatic hypotension and bowel dysfunction Participation will last approximately 10 weeks (excluding screening period) and involves * Attending the study center to collect baseline evaluations and to plan where electrodes will be placed * A 2 week treatment period at the centre with 3 visits per week * A 6 week home based therapy period involving 1 hour treatments twice a day * Attending the study center to collect post-treatment evaluations
Official title: The Safety and Feasibility of Home-based Non-invasive Spinal Cord Stimulation for Orthostatic Hypotension in Individuals with Severe Autonomic Dysfunctions
Key Details
Gender
All
Age Range
19 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
6
Start Date
2024-02-15
Completion Date
2026-04-01
Last Updated
2025-02-20
Healthy Volunteers
No
Interventions
Spinal COrd NEuromodulation ("SCONE") Device
A non-invasive electrical device that provides transcutaneous spinal cord stimulation (TSCS) to the spinal cord by electrodes connected to a battery-powered source.
Locations (1)
ICORD, Blusson Spinal Cord Centre
Vancouver, British Columbia, Canada