Short Duration Electrical Stimulation to Improve Outcomes After Cubital Tunnel Release (SELECT) Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Epineuron Technologies Inc.
- Enrollment
- 26
- Locations
- 3
- Primary Endpoint
- Recruitment Rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Experimental Intervention
Standard of care plus therapy, which consists of a single, 1 hour dose of electrical stimulation.
Intervention: Temporary Peripheral Nerve Stimulation System (Device)
Control
Standard of care only.
Outcomes
Primary Outcomes
Recruitment Rate
Time Frame: 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
Time Frame: 1.5 years
Evaluation of study feasibility through the number of participants who complete all study activities
Eligibility Rate
Time Frame: 1.5 years
Evaluation of study feasibility through the number of participants who pass all pre-operative screening eligibility criteria
Secondary Outcomes
No secondary outcomes reported