Regeneration of Acutely Injured Nerves With Temporary Electrical Stimulation (REGAIN)

March 12, 2026 updated by: Epineuron Technologies Inc.
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada
        • Completed
        • University of Alberta Hospital
    • New Brunswick
      • Saint John, New Brunswick, Canada
        • Recruiting
        • Saint John Regional Hospital
        • Principal Investigator:
          • Alison Wong, MD, MSc, FRCSC
    • Ontario
      • Hamilton, Ontario, Canada
        • Recruiting
        • Hamilton General Hospital
        • Principal Investigator:
          • James Bain, MD, MSc, FRCSC
        • Sub-Investigator:
          • Genevieve Dostaler, MD, MHA, FRCSC
        • Sub-Investigator:
          • Brian Hyosuk Chin, MD, MSc, FRCSC
      • Hamilton, Ontario, Canada
        • Recruiting
        • St. Joseph's Healthcare Hamilton
        • Principal Investigator:
          • Carolyn Levis, MD, MSc, FRCSC
      • London, Ontario, Canada
        • Active, not recruiting
        • Roth | McFarlane Hand & Upper Limb Centre
      • Newmarket, Ontario, Canada
        • Recruiting
        • Southlake Health
        • Principal Investigator:
          • Tomas Saun, MD, MASc, FRCSC
      • Toronto, Ontario, Canada
        • Recruiting
        • North York General Hospital
        • Principal Investigator:
          • Yasser El-Sheikh, MD, FRCSC
      • Toronto, Ontario, Canada
        • Recruiting
        • Trillium Health Partners
        • Principal Investigator:
          • Sharon Kim, MD, FRCSC
        • Sub-Investigator:
          • Brian Hong, MD
      • Toronto, Ontario, Canada
        • Recruiting
        • Humber River Health
        • Principal Investigator:
          • Jennica Platt, MD, MSc, FRCSC
        • Principal Investigator:
          • Olubukunola Ayeni, MD, FRCSC
  • United States
    • Florida
      • Gainesville, Florida, United States, 32608
        • Recruiting
        • University of Florida Health
        • Principal Investigator:
          • Ellen Satteson, MD
        • Sub-Investigator:
          • Tarek A El-Gammal, MD, PhD
        • Sub-Investigator:
          • Jongmin Kim, MD
      • Orlando, Florida, United States, 32806
        • Recruiting
        • Orlando Health Jewett Orthopedic Institute
        • Principal Investigator:
          • Karan Desai, MD, FAAOS
        • Sub-Investigator:
          • Justin Zumsteg, MD, FAAOS
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Recruiting
        • Louisiana State University Health Sciences Center
        • Principal Investigator:
          • Harvey Chim, MD, FACS
        • Sub-Investigator:
          • Kelly Babineaux, MD, FACS
        • Sub-Investigator:
          • Omer Kaymakcalan, MD
    • Maryland
      • Baltimore, Maryland, United States, 21218
        • Completed
        • The Curtis National Hand Center
    • Pennsylvania
      • York, Pennsylvania, United States, 17403
        • Completed
        • WellSpan Health
    • Texas
      • Fort Worth, Texas, United States, 76104
        • Recruiting
        • John Peter Smith Hospital
        • Principal Investigator:
          • William Pientka II, MD, FAAOS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion criteria:

  • Peripheral nerve injury

Exclusion criteria:

  • Peripheral neuropathy
  • Patients with any active implanted device

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active treatment
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 Comparator: Sham treatment
Device: Sham Temporary Peripheral Nerve Stimulation System
Single use medical device. Sham treatment consists of single, 1 hour dose of sham stimulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sensory recovery
Time Frame: 6 months
6 months
Cumulative incidence of adverse events
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Epineuron Technologies Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 11, 2023

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

February 1, 2023

First Submitted That Met QC Criteria

February 1, 2023

First Posted (Actual)

February 9, 2023

Study Record Updates

Last Update Posted (Actual)

March 16, 2026

Last Update Submitted That Met QC Criteria

March 12, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • EPNR-CIP-002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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