Short Duration Electrical Stimulation to Improve Outcomes After Cubital Tunnel Release (SELECT) Trial
Not Applicable
Recruiting
- Conditions
- Neuropathy;Peripheral
- Interventions
- Device: Temporary Peripheral Nerve Stimulation System
- Registration Number
- NCT05980767
- Lead Sponsor
- Epineuron Technologies Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 26
Inclusion Criteria
- Ulnar neuropathy at the elbow
Exclusion Criteria
- Peripheral neuropathy outside of nerve of interest
- Patients with any active implanted device
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental Intervention Temporary Peripheral Nerve Stimulation System Standard of care plus therapy, which consists of a single, 1 hour dose of electrical stimulation.
- Primary Outcome Measures
Name Time Method 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
Eligibility Rate 1.5 years Evaluation of study feasibility through the number of participants who pass all pre-operative screening eligibility criteria
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Hamilton General Hospital
🇨🇦Hamilton, Ontario, Canada
St. Joseph's Healthcare Hamilton
🇨🇦Hamilton, Ontario, Canada