Electrical stimulation to help regenerate injured nerves
Regeneration of Acutely Injured Nerves With Temporary Electrical Stimulation
This study is testing a new electrical stimulation treatment to see if it can help people with injured nerves recover better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Epineuron Technologies Inc. Industry-sponsored |
| Locations | 15 sites (Gainesville, Florida and 14 other locations) |
| Trial ID | NCT05721261 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates a novel temporary peripheral nerve stimulation system designed to deliver a single dose of electrical stimulation therapy for one hour. The study aims to assess the safety and effectiveness of this intervention in patients with peripheral nerve injuries. Participants will be randomly assigned to receive either the active stimulation or a sham treatment to compare outcomes. The goal is to determine if this approach can enhance nerve regeneration and recovery.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals with acute peripheral nerve injuries.
Not a fit: Patients with peripheral neuropathy or those who have any active implanted devices may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve recovery outcomes for patients with peripheral nerve injuries.
How similar studies have performed: While the approach is innovative, similar studies on electrical stimulation for nerve regeneration have shown promising results, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: * Peripheral nerve injury Exclusion criteria: * Peripheral neuropathy * Patients with any active implanted device
Where this trial is running
Gainesville, Florida and 14 other locations
- University of Florida Health — Gainesville, Florida, United States (Recruiting)
- Orlando Health Jewett Orthopedic Institute — Orlando, Florida, United States (Recruiting)
- Louisiana State University Health Sciences Center — New Orleans, Louisiana, United States (Recruiting)
- The Curtis National Hand Center — Baltimore, Maryland, United States (Completed)
- WellSpan Health — York, Pennsylvania, United States (Completed)
- John Peter Smith Hospital — Fort Worth, Texas, United States (Recruiting)
- University of Alberta Hospital — Edmonton, Alberta, Canada (Completed)
- Saint John Regional Hospital — Saint John, New Brunswick, Canada (Recruiting)
- Hamilton General Hospital — Hamilton, Ontario, Canada (Recruiting)
- St. Joseph's Healthcare Hamilton — Hamilton, Ontario, Canada (Recruiting)
- Roth | McFarlane Hand & Upper Limb Centre — London, Ontario, Canada (Active_not_recruiting)
- Southlake Health — Newmarket, Ontario, Canada (Recruiting)
- Humber River Health — Toronto, Ontario, Canada (Recruiting)
- North York General Hospital — Toronto, Ontario, Canada (Recruiting)
- Trillium Health Partners — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Tracy Cameron, PhD
- Email: tcameron@epineurontech.com
- Phone: 905-206-0466
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.