NCT06838637

Transcutaneous Spinal Cord Stimulation Home Study

The Safety and Feasibility of Home-based Non-invasive Spinal Cord Stimulation for Orthostatic Hypotension in Individuals with Severe Autonomic Dysfunctions

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: Michael Berger · Academic / Other
• Sex: All
• Age: 19 Years – 70 Years
• Healthy volunteers: Not accepted

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

Detailed description

Visit 1 - Screening Visit 2 - Baseline Assessments Visit 3 - Baseline EMG Mapping of Spinal Cord Segments with transcutaneous spinal cord stimulation Visits 4-9 - Transcutaneous spinal cord stimulation HOME-BASED Therapy (6 weeks) Visit 10 - Post-treatment Autonomic Function Assessments Visit 11 - Post-treatment Cardiac Function Assessments

Conditions

• Spinal Cord Injuries
• Multiple System Atrophy, Parkinson Variant

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-02-15
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2025-02-20
• Last updated: 2025-02-20

Locations

1 site across 1 country: Canada