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 volunteersQualifiers
Ulnar neuropathy at the elbow
Disqualifiers
Peripheral neuropathy outside of nerve of interest
Patients with any active implanted device
Trial design
Parallel
Treatments tested in this trial
Temporary Peripheral Nerve Stimulation System
DeviceSingle use medical device. Therapy consists of single, 1 hour dose of electrical stimulation.
Treatment groups
Trial outcomes
Primary outcomes
Eligibility Rate
Evaluation of study feasibility through the number of participants who pass all pre-operative screening eligibility criteria
Recruitment Rate
Evaluation of study feasibility through the number of participants who complete informed consent and are randomized into a study arm
Retention Rate
Evaluation of study feasibility through the number of participants who complete all study activities
Other outcomes
Electromyography (EMG) Denervation Absence/Presence
Measurement of electrical activity of a muscle
Nerve Conduction Study (NCS)
Measurement of speed of electrical impulse through a nerve
Semmes-Weinstein Monofilament Test
Evaluation of sensory recovery through the measurement of a pressure detection threshold
Static Two-Point Discrimination
Evaluation of sensory recovery through the measurement of the threshold of discrimination
Sponsors and contacts
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Epineuron Technologies Inc.
Lead sponsor
Federal Economic Development Agency for Southern Ontario (FedDev Ontario)
Collaborator