Nerve InjuryNCT04732936
Feasibility Study of a Temporary Peripheral Nerve Stimulator
A study testing Temporary Peripheral Nerve Stimulator in people with Nerve Injury, run by Epineuron Technologies Inc. at 3 sites in Canada.
Trial summary
A novel temporary peripheral nerve stimulator will be evaluated for safety, usability, and preliminary efficacy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nerve Injury
- What is being tested?
- Temporary Peripheral Nerve Stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 3 sitesCanada
- Study dates
- 1 Apr 2021to 21 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Are between 18-65 years old
- Have a Sunderland II-V peripheral nerve injury of the upper extremity
- Are receiving surgery within 14 days of injury
Who cannot join
- Nerve plexus injuries (e.g. brachial plexus)
- Nerve gap requiring graft/conduit, or extreme joint flexion
- Polyneuropathies
- Cognitive impairment and non-English-speaking
- Uncontrolled diabetes
- Surgical intervention > 14 days of injury
- Co-enrollment in another clinical trial
- Pregnant women
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Hamilton General Hospital
Hamilton, Ontario, L8L2X2
McMaster University Medical Centre
Hamilton, Ontario, L8N3Z5
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N4A6
About this study
A novel temporary peripheral nerve stimulator will be evaluated for safety, usability, and preliminary efficacy.
- Conditions
- Nerve Injury
- Being tested
- Temporary Peripheral Nerve Stimulator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temporary Peripheral Nerve StimulatorDevice
Temporary Peripheral Nerve Stimulator to deliver 1-hr of electrical stimulation to injured nerves.
| Study group | Role | What they receive |
|---|---|---|
| Device Usability | Experimental | Device usability and safety will be evaluated. Receives: Device: Temporary Peripheral Nerve Stimulator |
| Preliminary Efficacy | Experimental | Preliminary treatment efficacy will be evaluated. Receives: Device: Temporary Peripheral Nerve Stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Tolerance to Therapy Questionnaire
Measured: Immediately after procedure
Static Two Point Discrimination
Measurement of spatial determination
Measured: 6 months
Semmes-Weinstein Monofilament Test
Measurement of pressure sensitivity
Measured: 6 months
DASH Questionnaire
Validated questionnaire for functionality in upper extremity injury
Measured: 6 months
Secondary outcomes (2)
Safety
As measured by the cumulative incidence of adverse events.
Measured: 6 months
Device Usability Questionnaire
Measured: Immediately after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2021
- Study start1 Apr 2021
- Primary completion21 Jun 2023
- Study completion21 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Epineuron Technologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christopher Coroneos, MD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04732936
- Sponsor's protocol ID
- EPNR-CIP-001
- Status last verified
- Jul 2023
- First submitted
- 19 Jan 2021
- Last updated
- 13 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Coroneos CJ, Levis C, Willand MP, So KJ, Bain JR. Clinical evaluation of a novel disposable neurostimulator used to accelerate regeneration of injured peripheral nerves in the hand. Bioelectron Med. 2025 Apr 25;11(1):9. doi: 10.1186/s42234-025-00171-y.
PubMed 40275339
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of a Temporary Peripheral Nerve Stimulator
- ClinicalTrials.gov ID
- NCT04732936
- Acronym / sponsor ID
- EPNR-CIP-001
- Conditions
- Nerve Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Epineuron Technologies Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 21 Jun 2023 (actual)
- Study completion
- 21 Jun 2023 (actual)
- First posted
- 1 Feb 2021 (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 stimulator will be evaluated for safety, usability, and preliminary efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Device Usability | Experimental | Device: Temporary Peripheral Nerve StimulatorDevice usability and safety will be evaluated. |
| Preliminary Efficacy | Experimental | Device: Temporary Peripheral Nerve StimulatorPreliminary treatment efficacy will be evaluated. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Are between 18-65 years old
- Have a Sunderland II-V peripheral nerve injury of the upper extremity
- Are receiving surgery within 14 days of injury
Key exclusion criteria (8 listed)
- Nerve plexus injuries (e.g. brachial plexus)
- Nerve gap requiring graft/conduit, or extreme joint flexion
- Polyneuropathies
- Cognitive impairment and non-English-speaking
- Uncontrolled diabetes
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 StimulatorTemporary Peripheral Nerve Stimulator to deliver 1-hr of electrical stimulation to injured nerves. | Device | Device Usability, Preliminary Efficacy |
Primary outcome
Patient Tolerance to Therapy Questionnaire
Time frame: Immediately after procedure
Static Two Point Discrimination
Time frame: 6 months
Measurement of spatial determination
Semmes-Weinstein Monofilament Test
Time frame: 6 months
Measurement of pressure sensitivity
DASH Questionnaire
Time frame: 6 months
Validated questionnaire for functionality in upper extremity injury
2 secondary outcomes
Safety
Time frame: 6 months
Device Usability Questionnaire
Time frame: Immediately after procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2023.
- Derived from this study: PubMed 40275339Coroneos CJ, Levis C, Willand MP, So KJ, Bain JR. Clinical evaluation of a novel disposable neurostimulator used to accelerate regeneration of injured peripheral nerves in the hand. Bioelectron Med. 2025 Apr 25;11(1):9. doi: 10.1186/s42234-025-00171-y.
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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. This study is not recruiting at the moment.
Christopher Coroneos, MD principal investigator
McMaster University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Temporary Peripheral Nerve Stimulator in people with Nerve Injury, run by Epineuron Technologies Inc. at 3 sites in Canada.
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 3 inclusion and 8 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: finished, as of the sponsor's last update on 13 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Tolerance to Therapy Questionnaire (time frame: Immediately after procedure). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04732936, which also lists 1 linked publication.
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 13 Jul 2023.