Short Duration Electrical Stimulation to Improve Outcomes After Cubital Tunnel Release (SELECT) Trial

Not Applicable

Recruiting

• Conditions: Neuropathy;Peripheral

• 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

Study Timeline

• Study First Submitted: 2023-07-14
• Study First Submitted QC: 2023-07-31
• Study First Posted: 2023-08-08
• Study Start: 2023-11-01
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-05
• Last Update Posted: 2025-08-08
• Primary Completion: 2025-12
• Study Completion: 2025-12-01

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

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

Trial Locations

Locations (2)

McMaster University Medical Centre; 🇨🇦 Hamilton, Ontario, Canada

Hamilton General Hospital; 🇨🇦 Hamilton, Ontario, Canada