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NCT Number: NCT05980767

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

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

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Key information

Conditions

Neuropathy;Peripheral Nervous System Diseases Neuritis Neuromuscular Diseases Peripheral Nervous System Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hamilton General Hospital, Hamilton, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ulnar neuropathy at the elbow

Exclusion criteria

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

Treatment and study plan

Temporary Peripheral Nerve Stimulation System

Device

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

Primary outcomes

  1. Eligibility Rate

    Time frame: 1.5 years

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

  2. 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

  3. Retention Rate

    Time frame: 1.5 years

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

Other outcomes

  1. Electromyography (EMG) Denervation Absence/Presence

    Time frame: 1.5 years

    Measurement of electrical activity of a muscle

  2. Nerve Conduction Study (NCS)

    Time frame: 1.5 years

    Measurement of speed of electrical impulse through a nerve

  3. Semmes-Weinstein Monofilament Test

    Time frame: 1.5 years

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

  4. Static Two-Point Discrimination

    Time frame: 1.5 years

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

  5. Grip strength

    Time frame: 1.5 years

    Evaluation of functional recovery through the measurement of maximum grip strength

  6. Pinch strength

    Time frame: 1.5 years

    Evaluation of functional recovery through the measurement of pinch strength

  7. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Katelyn So, MHSc

CONTACT

[email protected]

905-206-0466

Sponsors and collaborators

Lead sponsor

Epineuron Technologies Inc.

Industry

Collaborators

  • Federal Economic Development Agency for Southern Ontario (FedDev Ontario)

Registry information

Acronym: SELECT

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 8, 2023
Registry last updated
Aug 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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