Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
Healthy Volunteers
ID05721261

Regeneration of Acutely Injured Nerves With Temporary Electrical Stimulation

Led by Epineuron Technologies Inc. · Updated on 2026-03-16

110

Participants Needed

15

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating a novel temporary peripheral nerve stimulation system to study its safety and effectiveness in helping regenerate acutely injured nerves. This study is designed to assess sensory recovery and monitor adverse events over a six-month period in adults with nerve injuries. The trial is randomized and double-blinded to compare the nerve stimulation device with a sham treatment. Participants will receive a single dose of electrical stimulation therapy lasting one hour, delivered by a single-use medical device placed near the injury site. The study groups include an active treatment group receiving the actual nerve stimulation and a sham group receiving a similar procedure without active stimulation. Both treatments are given once. Throughout the study, participants will be monitored for sensory recovery and any adverse effects at the six-month mark. The trial includes regular evaluations to track the progress of nerve regeneration and the safety of the device. The total participation period covers six months from treatment to final assessment.

CONDITIONS

Brief Title

Regeneration of Acutely Injured Nerves With Temporary Electrical Stimulation

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Peripheral nerve injury
  • Aged between 18 and 65 years
  • All genders are eligible
Not Eligible

You will not qualify if you...

  • Peripheral neuropathy
  • Presence of any active implanted medical device

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Single session

Participants receive a single, 1 hour dose of electrical stimulation or sham stimulation near the nerve injury site.

1 visit (in-person)

Long-term Monitoring

Duration - 6 months

Participants are monitored for sensory recovery and incidence of adverse events over 6 months.

Periodic follow-up visits during 6 months

Trial Site Locations

Total: 15 locations

1

University of Florida Health

Gainesville, Florida, United States, 32608

Actively Recruiting

2

Orlando Health Jewett Orthopedic Institute

Orlando, Florida, United States, 32806

Actively Recruiting

3

Louisiana State University Health Sciences Center

New Orleans, Louisiana, United States, 70112

Actively Recruiting

4

The Curtis National Hand Center

Baltimore, Maryland, United States, 21218

Completed

5

WellSpan Health

York, Pennsylvania, United States, 17403

Completed

6

John Peter Smith Hospital

Fort Worth, Texas, United States, 76104

Actively Recruiting

7

University of Alberta Hospital

Edmonton, Alberta, Canada

Completed

8

Saint John Regional Hospital

Saint John, New Brunswick, Canada

Actively Recruiting

9

Hamilton General Hospital

Hamilton, Ontario, Canada

Actively Recruiting

10

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

Actively Recruiting

11

Roth | McFarlane Hand & Upper Limb Centre

London, Ontario, Canada

Active, Not Recruiting

12

Southlake Health

Newmarket, Ontario, Canada

Actively Recruiting

13

Humber River Health

Toronto, Ontario, Canada

Actively Recruiting

14

North York General Hospital

Toronto, Ontario, Canada

Actively Recruiting

15

Trillium Health Partners

Toronto, Ontario, Canada

Actively Recruiting

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Research Team

T

Tracy Cameron, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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