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NCT05721261 Clinical Trial

Regeneration of Acutely Injured Nerves With Temporary Electrical Stimulation

Nerve Injury Clinical Trial

— REGAIN  

Official title:
Regeneration of Acutely Injured Nerves With Temporary Electrical Stimulation

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05721261
Other study ID # EPNR-CIP-002
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 11, 2023
Est. completion date December 2024

Study information
Verified date April 2024
Source Epineuron Technologies Inc.
Contact Tracy Cameron, PhD
Phone 905-206-0466
Email tcameron@epineurontech.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 110
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion criteria: - Peripheral nerve injury Exclusion criteria: - Peripheral neuropathy - Patients with any active implanted device

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Temporary Peripheral Nerve Stimulation System
Single use medical device. Therapy consists of single, 1 hour dose of electrical stimulation delivered proximal to injury site.
• Sham Temporary Peripheral Nerve Stimulation System
Single use medical device. Sham treatment consists of single, 1 hour dose of sham stimulation.

Locations
Country Name City State
Canada 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
United States The Curtis National Hand Center Baltimore Maryland
United States WellSpan Health York Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
Epineuron Technologies Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Sensory recovery 6 months
Primary Cumulative incidence of adverse events 6 months
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