๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-02-17

Transcutaneous Spinal Cord Stimulation Home Study (NCT06838637)

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

๐ŸŸข Recruiting Observational / Diagnostic โš™๏ธ Medical Device Protocol Sponsor: Michael Berger

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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

Who can join: Review the eligibility criteria below.

Location: ICORD, Blusson Spinal Cord Centre โ€” Vancouver, British Columbia

Age range: 19 Years to 70 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (1 Sites)

  • ICORD, Blusson Spinal Cord Centre โ€” Vancouver, British Columbia

๐Ÿ“ž Contact the Study Coordinator

Phone: (604) 675-8856

Email: amaharaj@icord.org

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—