Neuropathy;Peripheral
Conditions
Brief summary
A novel temporary peripheral nerve stimulation system that delivers electrical stimulation therapy in a cubital tunnel release model will be evaluated for feasibility.
Interventions
Single use medical device. Therapy consists of single, 1 hour dose of electrical stimulation.
Sponsors
Federal Economic Development Agency for Southern Ontario (FedDev Ontario)
Epineuron Technologies Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Ulnar neuropathy at the elbow
Exclusion criteria
* Peripheral neuropathy outside of nerve of interest * Patients with any active implanted device
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retention Rate | 1.5 years | Evaluation of study feasibility through the number of participants who complete all study activities |
| Recruitment Rate | 1.5 years | Evaluation of study feasibility through the number of participants who complete informed consent and are randomized into a study arm |
| Eligibility Rate | 1.5 years | Evaluation of study feasibility through the number of participants who pass all pre-operative screening eligibility criteria |
Other
| Measure | Time frame | Description |
|---|---|---|
| Static Two-Point Discrimination | 1.5 years | Evaluation of sensory recovery through the measurement of the threshold of discrimination |
| Grip strength | 1.5 years | Evaluation of functional recovery through the measurement of maximum grip strength |
| Electromyography (EMG) Denervation Absence/Presence | 1.5 years | Measurement of electrical activity of a muscle |
| Patient Rated Ulnar Nerve Evaluation (PRUNE) | 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 |
| Pinch strength | 1.5 years | Evaluation of functional recovery through the measurement of pinch strength |
| Nerve Conduction Study (NCS) | 1.5 years | Measurement of speed of electrical impulse through a nerve |
| Semmes-Weinstein Monofilament Test | 1.5 years | Evaluation of sensory recovery through the measurement of a pressure detection threshold |
Countries
Canada
Contacts
Primary ContactKatelyn So, MHSc
Outcome results
None listed