Recruiting

Peripheral Nerve Stimulation

Sponsor:

Epineuron Technologies Inc.

Code:

NCT05721261

Conditions

Nerve Injury

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Temporary Peripheral Nerve Stimulation System

Sham Temporary Peripheral Nerve Stimulation System

Study Details

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.

Conditions

Nerve Injury

Study ID

NCT05721261

Start date

Aug 11, 2023

Status verified date

Mar, 2026

Completion date

Sep, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Inclusion criteria:

  • Peripheral nerve injury

Exclusion criteria:

  • Peripheral neuropathy
  • Patients with any active implanted device

Study Design

Enrollment

110 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Active treatment

sham comparator: Sham treatment

Interventions

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.

Primary outcome measure

  • Sensory recovery [ Time Frame: 6 months ]
  • Cumulative incidence of adverse events [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Tracy Cameron, PhD

905-206-0466tcameron@epineurontech.com

Locations

University of Florida Health

Recruiting

Gainesville, Florida, United States, 32608

Principal Investigator:

Ellen Satteson, MD

Orlando Health Jewett Orthopedic Institute

Recruiting

Orlando, Florida, United States, 32806

Principal Investigator:

Karan Desai, MD, FAAOS

Louisiana State University Health Sciences Center

Recruiting

New Orleans, Louisiana, United States, 70112

Principal Investigator:

Harvey Chim, MD, FACS

John Peter Smith Hospital

Recruiting

Fort Worth, Texas, United States, 76104

Principal Investigator:

William Pientka II, MD, FAAOS

Saint John Regional Hospital

Recruiting

Saint John, New Brunswick, Canada

Principal Investigator:

Alison Wong, MD, MSc, FRCSC

Hamilton General Hospital

Recruiting

Hamilton, Ontario, Canada

Principal Investigator:

James Bain, MD, MSc, FRCSC

St. Joseph's Healthcare Hamilton

Recruiting

Hamilton, Ontario, Canada

Principal Investigator:

Carolyn Levis, MD, MSc, FRCSC

Southlake Health

Recruiting

Newmarket, Ontario, Canada

Principal Investigator:

Tomas Saun, MD, MASc, FRCSC

Humber River Health

Recruiting

Toronto, Ontario, Canada

Principal Investigator:

Jennica Platt, MD, MSc, FRCSC

North York General Hospital

Recruiting

Toronto, Ontario, Canada

Principal Investigator:

Yasser El-Sheikh, MD, FRCSC

Trillium Health Partners

Recruiting

Toronto, Ontario, Canada

Principal Investigator:

Sharon Kim, MD, FRCSC

More Information

Sponsor

Epineuron Technologies Inc.

Last update posted

Mar 16, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Epineuron Technologies Inc. on 2026-03-16.