Actively Recruiting
Short Duration Electrical Stimulation to Improve Outcomes After Cubital Tunnel Release (SELECT) Trial
Led by Epineuron Technologies Inc. · Updated on 2025-08-08
26
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
E
Epineuron Technologies Inc.
Lead Sponsor
F
Federal Economic Development Agency for Southern Ontario (FedDev Ontario)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a temporary peripheral nerve stimulation system to deliver electrical stimulation therapy for people undergoing cubital tunnel release surgery. The study aims to assess the feasibility of this novel treatment approach in improving outcomes for patients with ulnar neuropathy at the elbow. Participants will be randomly assigned to one of two groups: one group will receive standard care plus a single, one-hour dose of electrical stimulation using the temporary peripheral nerve stimulation system, while the other group will receive standard care only. This device is a single-use medical device designed to provide targeted electrical stimulation during the treatment period. During the study, researchers will track eligibility, recruitment, and retention rates over 1.5 years to understand how well the trial is conducted. Participants will be monitored for treatment adherence and outcomes during this time. The study welcomes healthy volunteers aged 18 to 80 years and includes evaluations related to neuropathy symptoms and safety of the intervention.
CONDITIONS
Brief Title
Short Duration Electrical Stimulation to Improve Outcomes After Cubital Tunnel Release (SELECT) Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ulnar neuropathy at the elbow
You will not qualify if you...
- Peripheral neuropathy outside of nerve of interest
- Patients with any active implanted device
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day
Participants undergo cubital tunnel release surgery and receive a single 1-hour dose of electrical stimulation therapy or standard care without the device.
1 visit (in-person)
Duration - Up to 1.5 years
Participants are followed to monitor recovery and evaluate outcomes after surgery and therapy.
Follow-up visits as scheduled
Trial Site Locations
Total: 2 locations
1
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2
Actively Recruiting
2
McMaster University Medical Centre
Hamilton, Ontario, Canada, L8N 3Z5
Actively Recruiting
Research Team
K
Katelyn So, MHSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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