Transcutaneous Spinal Cord Stimulation Home Study

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

Conditions

• Spinal Cord Injuries
• Multiple System Atrophy, Parkinson Variant

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.

Sponsors & Collaborators

• Vancouver Coastal Health Research Institute

  collaborator OTHER

• International Collaboration on Repair Discoveries

  collaborator OTHER

• SpineX Inc.

  collaborator INDUSTRY

• Vancouver Coastal Health

  collaborator OTHER_GOV

• University of British Columbia

  collaborator OTHER

• Rick Hansen Foundation

  collaborator OTHER

• Michael Berger

  lead OTHER

Principal Investigators

• Michael J Berger, MD, FRCPC · The University of British Columbia

• Andrei Krassioukov, MD, FRCPC · The University of British Columbia

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

19 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-02-15

Primary Completion

2026-04-01

Completion

2026-04-01

Countries

• Canada

Study Locations