Electrical stimulation to improve recovery after cubital tunnel surgery
Short Duration Electrical Stimulation to Improve Outcomes After Cubital Tunnel Release (SELECT) Trial
This study is testing a new electrical stimulation treatment to see if it helps people recover better after surgery for cubital tunnel syndrome.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 26 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Epineuron Technologies Inc. Industry-sponsored |
| Locations | 2 sites (Hamilton, Ontario and 1 other locations) |
| Trial ID | NCT05980767 on ClinicalTrials.gov |
What this trial studies
This trial evaluates a novel temporary peripheral nerve stimulation system designed to deliver electrical stimulation therapy in patients undergoing cubital tunnel release surgery. The primary focus is on assessing the feasibility of this intervention in improving outcomes for individuals with ulnar neuropathy at the elbow. Participants will receive the stimulation therapy post-surgery to determine its effectiveness in enhancing recovery. The study aims to gather data on the safety and potential benefits of this innovative approach.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with ulnar neuropathy at the elbow who are scheduled for cubital tunnel release surgery.
Not a fit: Patients with peripheral neuropathy affecting nerves outside of the ulnar nerve or those with active implanted devices may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve recovery times and outcomes for patients undergoing cubital tunnel release surgery.
How similar studies have performed: While this approach is innovative, similar studies evaluating electrical stimulation for nerve recovery have shown promising results, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Ulnar neuropathy at the elbow Exclusion Criteria: * Peripheral neuropathy outside of nerve of interest * Patients with any active implanted device
Where this trial is running
Hamilton, Ontario and 1 other locations
- Hamilton General Hospital — Hamilton, Ontario, Canada (Recruiting)
- McMaster University Medical Centre — Hamilton, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Katelyn So, MHSc
- Email: clinops@epineurontech.com
- Phone: 905-206-0466
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.