Short Duration Electrical Stimulation to Improve Outcomes After Cubital Tunnel Release (SELECT) Trial
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| 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. |
Outcome Measures
Primary Outcome Measures
- Eligibility Rate [1.5 years]
Evaluation of study feasibility through the number of participants who pass all pre-operative screening eligibility criteria
- 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
- Retention Rate [1.5 years]
Evaluation of study feasibility through the number of participants who complete all study activities
Other Outcome Measures
- Electromyography (EMG) Denervation Absence/Presence [1.5 years]
Measurement of electrical activity of a muscle
- 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
- 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
- Pinch strength [1.5 years]
Evaluation of functional recovery through the measurement of pinch strength
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
- Ulnar neuropathy at the elbow
Exclusion Criteria:
-
Peripheral neuropathy outside of nerve of interest
-
Patients with any active implanted device
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Epineuron Technologies Inc.
- Federal Economic Development Agency for Southern Ontario (FedDev Ontario)
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EPNR-CIP-003