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Electrical Stimulation for Peripheral Neuropathy (SELECT Trial)
N/A
Recruiting
Research Sponsored by Epineuron Technologies Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1.5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial will test an electrical stimulation system to help treat elbow-related nerve problems.
Who is the study for?
This trial is for individuals with ulnar neuropathy at the elbow, which is a condition affecting the nerve on the inner side of the elbow. It's not suitable for people who have an active implanted device or peripheral neuropathy that affects nerves other than the one of interest.
What is being tested?
The study is testing a new temporary nerve stimulation system designed to be used after surgery for cubital tunnel syndrome. The goal is to see if this electrical stimulation can help improve recovery outcomes.
What are the potential side effects?
Potential side effects may include discomfort at the site of stimulation, skin irritation, and possible muscle twitching during use. Since it's a novel system, part of the study will monitor for any unexpected reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1.5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Eligibility Rate
Recruitment Rate
Retention Rate
Other study objectives
Electromyography (EMG) Denervation Absence/Presence
Grip strength
Nerve Conduction Study (NCS)
+4 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: ControlActive Control1 Intervention
Standard of care only.
Group II: Experimental InterventionActive Control1 Intervention
Standard of care plus therapy, which consists of a single, 1 hour dose of electrical stimulation.
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Who is running the clinical trial?
Federal Economic Development Agency for Southern Ontario (FedDev Ontario)OTHER
3 Previous Clinical Trials
562 Total Patients Enrolled
Epineuron Technologies Inc.Lead Sponsor
2 Previous Clinical Trials
135 Total Patients Enrolled