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

August 5, 2025 updated by: Epineuron Technologies Inc.
A novel temporary peripheral nerve stimulation system that delivers electrical stimulation therapy in a cubital tunnel release model will be evaluated for feasibility.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Ulnar neuropathy at the elbow

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Single use medical device. Therapy consists of single, 1 hour dose of electrical stimulation.
No Intervention: Control
Standard of care only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Eligibility Rate
Time Frame: 1.5 years
Evaluation of study feasibility through the number of participants who pass all pre-operative screening eligibility criteria
1.5 years
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
1.5 years
Retention Rate
Time Frame: 1.5 years
Evaluation of study feasibility through the number of participants who complete all study activities
1.5 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Electromyography (EMG) Denervation Absence/Presence
Time Frame: 1.5 years
Measurement of electrical activity of a muscle
1.5 years
Nerve Conduction Study (NCS)
Time Frame: 1.5 years
Measurement of speed of electrical impulse through a nerve
1.5 years
Semmes-Weinstein Monofilament Test
Time Frame: 1.5 years
Evaluation of sensory recovery through the measurement of a pressure detection threshold
1.5 years
Static Two-Point Discrimination
Time Frame: 1.5 years
Evaluation of sensory recovery through the measurement of the threshold of discrimination
1.5 years
Grip strength
Time Frame: 1.5 years
Evaluation of functional recovery through the measurement of maximum grip strength
1.5 years
Pinch strength
Time Frame: 1.5 years
Evaluation of functional recovery through the measurement of pinch strength
1.5 years
Patient Rated Ulnar Nerve Evaluation (PRUNE)
Time Frame: 1.5 years
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
1.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Epineuron Technologies Inc.

Collaborators

Federal Economic Development Agency for Southern Ontario (FedDev Ontario)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2023

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

July 14, 2023

First Submitted That Met QC Criteria

July 31, 2023

First Posted (Actual)

August 8, 2023

Study Record Updates

Last Update Posted (Actual)

August 8, 2025

Last Update Submitted That Met QC Criteria

August 5, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPNR-CIP-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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