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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorEpineuron Technologies Inc.

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Ulnar neuropathy at the elbow

Disqualifiers

Peripheral neuropathy outside of nerve of interest

Patients with any active implanted device

Trial design

Design model

Parallel

Treatments tested in this trial

  • Temporary Peripheral Nerve Stimulation System

    Device

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

Treatment groups

26 Participants
are divided into 2 treatment groups
Group A: Experimental InterventionActive comparator 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

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

Secondary outcomes

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Epineuron Technologies Inc.

Lead sponsor

Federal Economic Development Agency for Southern Ontario (FedDev Ontario)

Collaborator