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RECRUITING
NCT06838637
NA

Transcutaneous Spinal Cord Stimulation Home Study

Sponsor: Michael Berger

View on ClinicalTrials.gov

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

DEVICE

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