Regeneration of Acutely Injured Nerves with Temporary Electrical Stimulation
- Conditions
- Nerve Injury
- Interventions
- Device: Temporary Peripheral Nerve Stimulation SystemDevice: Sham Temporary Peripheral Nerve Stimulation System
- Registration Number
- NCT05721261
- Lead Sponsor
- Epineuron Technologies Inc.
- Brief Summary
A novel temporary peripheral nerve stimulation system that delivers a single dose of electrical stimulation therapy for 1 hour will be evaluated for safety and effectiveness.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 110
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active treatment Temporary Peripheral Nerve Stimulation System - Sham treatment Sham Temporary Peripheral Nerve Stimulation System -
- Primary Outcome Measures
Name Time Method Cumulative incidence of adverse events 6 months Sensory recovery 6 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (11)
University of Florida Health
🇺🇸Gainesville, Florida, United States
Orlando Health Jewett Orthopedic Institute
🇺🇸Orlando, Florida, United States
The Curtis National Hand Center
🇺🇸Baltimore, Maryland, United States
WellSpan Health
🇺🇸York, Pennsylvania, United States
John Peter Smith Hospital
🇺🇸Fort Worth, Texas, United States
University of Alberta Hospital
🇨🇦Edmonton, Alberta, Canada
Hamilton General Hospital
🇨🇦Hamilton, Ontario, Canada
St. Joseph's Healthcare Hamilton
🇨🇦Hamilton, Ontario, Canada
Roth | McFarlane Hand & Upper Limb Centre
🇨🇦London, Ontario, Canada
North York General Hospital
🇨🇦Toronto, Ontario, Canada
Trillium Health Partners
🇨🇦Toronto, Ontario, Canada