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RecruitingNCT05980767SELECTUpdated Aug 8, 2025

Short Duration Electrical Stimulation to Improve Outcomes After Cubital Tunnel Release (SELECT) Trial

An interventional study of Temporary Peripheral Nerve Stimulation System in Neuropathy;Peripheral, sponsored by Epineuron Technologies Inc.. Recruiting at 2 sites in Canada. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-08.

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

From the registry’s dates

  • Primary completion was expected by Dec 2025, 11 months ago, but the record still lists the study as recruiting.
  • Started Nov 2023; still recruiting 3 years later.
Phase
Not applicable
Study type
Interventional
Enrollment
26
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

A novel temporary peripheral nerve stimulation system that delivers electrical stimulation therapy in a cubital tunnel release model will be evaluated for feasibility.

02

Conditions studied

  • Neuropathy;Peripheral

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03

In context

Neuritis

73 studies on the registry are indexed under Neuritis; 20 are open to participants now.

This study's planned enrollment of 26 is below the median of 48 across 51 interventional studies indexed under Neuritis.

Browse Neuritis studies →

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.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Ulnar neuropathy at the elbow

Exclusion criteria

Exclusion Criteria:

  • Peripheral neuropathy outside of nerve of interest
  • Patients with any active implanted device
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
26 participants (estimated)

Study arms

  • Active comparator
    Experimental Intervention

    Standard of care plus therapy, which consists of a single, 1 hour dose of electrical stimulation.

    Device: Temporary Peripheral Nerve Stimulation System

  • No intervention
    Control

    Standard of care only.

Interventions

  • DeviceTemporary Peripheral Nerve Stimulation System

    Single use medical device. Therapy consists of single, 1 hour dose of electrical stimulation.

06

What researchers measure

Primary outcomes

  1. Eligibility Rate

    Evaluation of study feasibility through the number of participants who pass all pre-operative screening eligibility criteria

    Time frame: 1.5 years

  2. Recruitment Rate

    Evaluation of study feasibility through the number of participants who complete informed consent and are randomized into a study arm

    Time frame: 1.5 years

  3. Retention Rate

    Evaluation of study feasibility through the number of participants who complete all study activities

    Time frame: 1.5 years

Other outcomes

  1. Electromyography (EMG) Denervation Absence/Presence

    Measurement of electrical activity of a muscle

    Time frame: 1.5 years

  2. Nerve Conduction Study (NCS)

    Measurement of speed of electrical impulse through a nerve

    Time frame: 1.5 years

  3. Semmes-Weinstein Monofilament Test

    Evaluation of sensory recovery through the measurement of a pressure detection threshold

    Time frame: 1.5 years

  4. Static Two-Point Discrimination

    Evaluation of sensory recovery through the measurement of the threshold of discrimination

    Time frame: 1.5 years

  5. Grip strength

    Evaluation of functional recovery through the measurement of maximum grip strength

    Time frame: 1.5 years

  6. Pinch strength

    Evaluation of functional recovery through the measurement of pinch strength

    Time frame: 1.5 years

  7. Patient Rated Ulnar Nerve Evaluation (PRUNE)

    Evaluation of pain and quality of life through patient-reported questionnaire where lower scores indicate lower pain and better quality of life related to the injury

    Time frame: 1.5 years

07

Study locations

2 of 2 sites recruiting
  • Hamilton General Hospital
    Hamilton, Ontario L8L 2X2, Canada
    Recruiting
    • Dr. James Bain, MD, MSc, FRCSC · Principal investigator
    • Dr. Hyosuk (Brian) Chin, MD, FRCSC · Sub investigator
    • Dr. Genevieve Dostaler, MD, FRCSC · Sub investigator
  • McMaster University Medical Centre
    Hamilton, Ontario L8N 3Z5, Canada
    Recruiting
    • Dr. Adrian Opala, MD, FRCPC, CSCN · Sub investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2023 (actual). Primary completion is estimated for Dec 2025, 25 months after the start.

Of 23 interventional studies with no phase under Neuritis, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 31. This study's planned 25 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 14, 2023
First posted
Aug 8, 2023
StartActual
Nov 1, 2023
Primary completionEst.
Dec 2025
CompletionEst.
Dec 2025
Last update
Aug 8, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05980767
Lead sponsor
Epineuron Technologies Inc.
Collaborators
Federal Economic Development Agency for Southern Ontario (FedDev Ontario)
Responsible party
Sponsor
First posted
Aug 8, 2023
Start date
Nov 1, 2023
Primary completion
Dec 2025 (estimated)
Completion
Dec 2025 (estimated)
Last update
Aug 8, 2025

Study contacts

Katelyn So, MHSc
Contact
clinops@epineurontech.com
905-206-0466

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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