Neuropathy;PeripheralSELECTNCT05980767
Short Duration Electrical Stimulation to Improve Outcomes After Cubital Tunnel Release (SELECT) Trial
A study testing Temporary Peripheral Nerve Stimulation System in people with Neuropathy;Peripheral, run by Epineuron Technologies Inc. at 2 sites in Canada.
Trial summary
A novel temporary peripheral nerve stimulation system that delivers electrical stimulation therapy in a cubital tunnel release model will be evaluated for feasibility. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Neuropathy;Peripheral
- What is being tested?
- Temporary Peripheral Nerve Stimulation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Nov 2023to Dec 2025
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ulnar neuropathy at the elbow
Who cannot join
- Peripheral neuropathy outside of nerve of interest
- Patients with any active implanted device
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
Hamilton General Hospital
Hamilton, Ontario, L8L 2X2
Dr. James Bain, MD, MSc, FRCSC
Dr. Hyosuk (Brian) Chin, MD, FRCSC
- Recruiting
McMaster University Medical Centre
Hamilton, Ontario, L8N 3Z5
Dr. Adrian Opala, MD, FRCPC, CSCN
About this study
A novel temporary peripheral nerve stimulation system that delivers electrical stimulation therapy in a cubital tunnel release model will be evaluated for feasibility.
- Conditions
- Neuropathy;Peripheral
- Being tested
- Temporary Peripheral Nerve Stimulation System
- Medical subject headings
- Neuritis
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Intervention | Active comparator | Standard of care plus therapy, which consists of a single, 1 hour dose of electrical stimulation. Receives: Device: Temporary Peripheral Nerve Stimulation System |
| Control | No intervention | Standard of care only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eligibility Rate
Evaluation of study feasibility through the number of participants who pass all pre-operative screening eligibility criteria
Measured: 1.5 years
Recruitment Rate
Evaluation of study feasibility through the number of participants who complete informed consent and are randomized into a study arm
Measured: 1.5 years
Retention Rate
Evaluation of study feasibility through the number of participants who complete all study activities
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start1 Nov 2023
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathy;PeripheralStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Epineuron Technologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Federal Economic Development Agency for Southern Ontario (FedDev Ontario)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05980767
- Sponsor's protocol ID
- EPNR-CIP-003
- Acronym
- SELECT
- Status last verified
- Aug 2025
- First submitted
- 14 Jul 2023
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Duration Electrical Stimulation to Improve Outcomes After Cubital Tunnel Release (SELECT) Trial
- ClinicalTrials.gov ID
- NCT05980767
- Acronym / sponsor ID
- SELECT / EPNR-CIP-003
- Conditions
- Neuropathy;Peripheral
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Epineuron Technologies Inc.Industry (pharma, biotech, devices)
- Collaborators
- Federal Economic Development Agency for Southern Ontario (FedDev Ontario)
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 8 Aug 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 electrical stimulation therapy in a cubital tunnel release model will be evaluated for feasibility.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Intervention | Active comparator | Device: Temporary Peripheral Nerve Stimulation SystemStandard of care plus therapy, which consists of a single, 1 hour dose of electrical stimulation. |
| Control | No intervention | –Standard of care only. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Ulnar neuropathy at the elbow
Key exclusion criteria (2 listed)
- Peripheral neuropathy outside of nerve of interest
- 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. | Device | Experimental Intervention |
Primary outcome
Eligibility Rate
Time frame: 1.5 years
Evaluation of study feasibility through the number of participants who pass all pre-operative screening eligibility criteria
Recruitment Rate
Time frame: 1.5 years
Evaluation of study feasibility through the number of participants who complete informed consent and are randomized into a study arm
Retention Rate
Time frame: 1.5 years
Evaluation of study feasibility through the number of participants who complete all study activities
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 8 Aug 2025.
- Individual participant dataSharing planned: No
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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.
2 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 Stimulation System in people with Neuropathy;Peripheral, run by Epineuron Technologies Inc. at 2 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 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 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
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 Katelyn So, MHSc (905-206-0466, clinops@epineurontech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eligibility Rate (time frame: 1.5 years). The study lists 3 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 8 Aug 2025.