RecruitingNCT05721261REGAINUpdated Mar 16, 2026

Regeneration of Acutely Injured Nerves With Temporary Electrical Stimulation

An interventional study of Temporary Peripheral Nerve Stimulation System and Sham Temporary Peripheral Nerve Stimulation System in Nerve Injury, sponsored by Epineuron Technologies Inc.. Recruiting at 15 sites in 2 countries. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-16.

Sponsored by Epineuron Technologies Inc. · Not applicable, Interventional, and Treatment

From the registry’s dates

Started Aug 2023; still recruiting 3 years 1 month later.

Phase: Not applicable
Study type: Interventional
Enrollment: 110
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: All

Study 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 studied

Nerve Injury

In context

Lead sponsor

Epineuron Technologies Inc. is the lead sponsor of 3 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Peripheral nerve injury

Exclusion criteria

Exclusion criteria:

Peripheral neuropathy
Patients with any active implanted device

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Outcomes assessor)
Enrollment: 110 participants (estimated)

Study arms

Experimental
Active treatment
Device: Temporary Peripheral Nerve Stimulation System
Sham comparator
Sham treatment
Device: Sham Temporary Peripheral Nerve Stimulation System

Interventions

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

What researchers measure

Primary outcomes

Sensory recovery
Time frame: 6 months
Cumulative incidence of adverse events
Time frame: 6 months

Study locations

11 of 15 sites recruiting

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

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05721261
Lead sponsor: Epineuron Technologies Inc.
Responsible party: Sponsor
First posted: Feb 9, 2023
Start date: Aug 11, 2023
Primary completion: Sep 2026 (estimated)
Completion: Sep 2026 (estimated)
Last update: Mar 16, 2026

Study contacts

Tracy Cameron, PhD

Contact

tcameron@epineurontech.com

905-206-0466

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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