Nerve InjuryREGAINNCT05721261
Regeneration of Acutely Injured Nerves With Temporary Electrical Stimulation
A study testing Temporary Peripheral Nerve Stimulation System in people with Nerve Injury, run by Epineuron Technologies Inc. at 15 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Nerve Injury
- What is being tested?
- Temporary Peripheral Nerve Stimulation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 15 sitesin 2 countries
- Study dates
- 11 Aug 2023to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Peripheral nerve injury
Who cannot join
- Peripheral neuropathy
- Patients with any active implanted device
Trial locations and contacts
15 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
15 sites in 2 countries
Canada9 sites, 7 recruiting
- Completed
University of Alberta Hospital
Edmonton, Alberta
- Recruiting
Hamilton General Hospital
Hamilton, Ontario
James Bain, MD, MSc, FRCSC
Genevieve Dostaler, MD, MHA, FRCSC
- Recruiting
St. Joseph's Healthcare Hamilton
Hamilton, Ontario
Carolyn Levis, MD, MSc, FRCSC
- Active, not recruiting
Roth | McFarlane Hand & Upper Limb Centre
London, Ontario
- Recruiting
Southlake Health
Newmarket, Ontario
Tomas Saun, MD, MASc, FRCSC
- Recruiting
Saint John Regional Hospital
Saint John, New Brunswick
Alison Wong, MD, MSc, FRCSC
- Recruiting
Humber River Health
Toronto, Ontario
Jennica Platt, MD, MSc, FRCSC
Olubukunola Ayeni, MD, FRCSC
- Recruiting
North York General Hospital
Toronto, Ontario
Yasser El-Sheikh, MD, FRCSC
- Recruiting
Trillium Health Partners
Toronto, Ontario
Sharon Kim, MD, FRCSC
Brian Hong, MD
United States6 sites, 4 recruiting
- Completed
The Curtis National Hand Center
Baltimore, Maryland, 21218
- Recruiting
John Peter Smith Hospital
Fort Worth, Texas, 76104
William Pientka II, MD, FAAOS
- Recruiting
University of Florida Health
Gainesville, Florida, 32608
Ellen Satteson, MD
Tarek A El-Gammal, MD, PhD
- Recruiting
Louisiana State University Health Sciences Center
New Orleans, Louisiana, 70112
Harvey Chim, MD, FACS
Kelly Babineaux, MD, FACS
- Recruiting
Orlando Health Jewett Orthopedic Institute
Orlando, Florida, 32806
Karan Desai, MD, FAAOS
Justin Zumsteg, MD, FAAOS
- Completed
WellSpan Health
York, Pennsylvania, 17403
About this study
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
- Being tested
- Temporary Peripheral Nerve Stimulation System, Sham Temporary Peripheral Nerve Stimulation System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temporary Peripheral Nerve Stimulation SystemDevice
Single use medical device. Therapy consists of single, 1 hour dose of electrical stimulation delivered proximal to injury site.
Sham Temporary Peripheral Nerve Stimulation SystemDevice
Single use medical device. Sham treatment consists of single, 1 hour dose of sham stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Active treatment | Experimental | Not described Receives: Device: Temporary Peripheral Nerve Stimulation System |
| Sham treatment | Sham comparator | Not described Receives: Device: Sham Temporary Peripheral Nerve Stimulation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensory recovery
Measured: 6 months
Cumulative incidence of adverse events
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2023
- Study start11 Aug 2023
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nerve InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Epineuron Technologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05721261
- Sponsor's protocol ID
- EPNR-CIP-002
- Acronym
- REGAIN
- Status last verified
- Mar 2026
- First submitted
- 1 Feb 2023
- Last updated
- 16 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regeneration of Acutely Injured Nerves With Temporary Electrical Stimulation
- ClinicalTrials.gov ID
- NCT05721261
- Acronym / sponsor ID
- REGAIN / EPNR-CIP-002
- Conditions
- Nerve Injury
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Epineuron Technologies Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Aug 2023 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 9 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active treatment | Experimental | Device: Temporary Peripheral Nerve Stimulation System |
| Sham treatment | Sham comparator | Device: Sham Temporary Peripheral Nerve Stimulation System |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Peripheral nerve injury
Key exclusion criteria (2 listed)
- Peripheral neuropathy
- Patients with any active implanted device
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Temporary Peripheral Nerve Stimulation SystemSingle use medical device. Therapy consists of single, 1 hour dose of electrical stimulation delivered proximal to injury site. | Device | Active treatment |
| Sham Temporary Peripheral Nerve Stimulation SystemSingle use medical device. Sham treatment consists of single, 1 hour dose of sham stimulation. | Device | Sham treatment |
Primary outcome
Sensory recovery
Time frame: 6 months
Cumulative incidence of adverse events
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
15 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Temporary Peripheral Nerve Stimulation System in people with Nerve Injury, run by Epineuron Technologies Inc. at 15 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Canada, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tracy Cameron, PhD (905-206-0466, tcameron@epineurontech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensory recovery (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.