Neuropathy;Peripheral Clinical Trial
— SELECTOfficial title:
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.
Status | Recruiting |
Enrollment | 26 |
Est. completion date | December 2025 |
Est. primary completion date | December 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Ulnar neuropathy at the elbow Exclusion Criteria: - Peripheral neuropathy outside of nerve of interest - Patients with any active implanted device |
Country | Name | City | State |
---|---|---|---|
Canada | Hamilton General Hospital | Hamilton | Ontario |
Canada | St. Joseph's Healthcare Hamilton | Hamilton | Ontario |
Lead Sponsor | Collaborator |
---|---|
Epineuron Technologies Inc. | Federal Economic Development Agency for Southern Ontario (FedDev Ontario) |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Electromyography (EMG) Denervation Absence/Presence | Measurement of electrical activity of a muscle | 1.5 years | |
Other | Nerve Conduction Study (NCS) | Measurement of speed of electrical impulse through a nerve | 1.5 years | |
Other | Semmes-Weinstein Monofilament Test | Evaluation of sensory recovery through the measurement of a pressure detection threshold | 1.5 years | |
Other | Static Two-Point Discrimination | Evaluation of sensory recovery through the measurement of the threshold of discrimination | 1.5 years | |
Other | Grip strength | Evaluation of functional recovery through the measurement of maximum grip strength | 1.5 years | |
Other | Pinch strength | Evaluation of functional recovery through the measurement of pinch strength | 1.5 years | |
Other | Patient Rated Ulnar Nerve Evaluation (PRUNE) | 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 | 1.5 years | |
Primary | Eligibility Rate | Evaluation of study feasibility through the number of participants who pass all pre-operative screening eligibility criteria | 1.5 years | |
Primary | Recruitment Rate | Evaluation of study feasibility through the number of participants who complete informed consent and are randomized into a study arm | 1.5 years | |
Primary | Retention Rate | Evaluation of study feasibility through the number of participants who complete all study activities | 1.5 years |
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