Electrical Stimulation for Cubital Tunnel Syndrome

(PHONES Trial)

Recruiting in Palo Alto (17 mi)

+4 other locations

Overseen by Amy M Moore, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Checkpoint Surgical Inc.

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This study is evaluating a new therapeutic use of electrical stimulation to promote nerve healing and improve functional recovery following surgical intervention for nerve compression. A single dose of the therapeutic stimulation is delivered as part of the surgical intervention to address compression of the ulnar nerve at the elbow.

Eligibility Criteria

This trial is for adults aged 18-80 with ulnar nerve compression at the elbow who are scheduled for surgery. They must have signs of muscle weakness or wasting and confirmed ulnar neuropathy through tests. People with severe heart conditions, other nerve injuries in the arm, overall nerve disorders affecting hands, or very weak grip strength cannot join.

Inclusion Criteria

Signed and dated informed consent form

I am between 18 and 80 years old.

I am eligible for surgery.

Exclusion Criteria

I am younger than 18 or older than 80.

I experience numbness or pain in my hands.

Previous history or current transection of ulnar nerve, or concomitant upper extremity nerve injury

Participant Groups

The study is testing a new use of electrical stimulation called Checkpoint BEST System to help heal nerves and improve hand function after surgery for ulnar nerve compression at the elbow. The treatment involves a single dose of stimulation during the surgical procedure.

Group I: Brief Electrical Stimulation Experimental Treatment 1 Intervention

Single, 10 minute dose of electrical stimulation delivered to the ulnar nerve during surgical intervention for cubital tunnel decompression.

Group II: Standard of Care Active Control 1 Intervention

Surgical intervention for cubital tunnel decompression.

Checkpoint BEST System is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Checkpoint BEST System for:

• Pain management
• Neuropathic pain
• Chronic low back pain
• Diabetic neuropathy

🇪🇺 Approved in European Union as Electrical Stimulation Therapy for:

• Pain management
• Neuropathic pain
• Muscle rehabilitation

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Stanford University Stanford, CA

Northwestern Feinberg School of Medicine - Department of Orthopaedic Surgery Chicago, IL

Washington University in St. Louis Saint Louis, MO

The Ohio State Univeristy - Department of Plastic and Reconstructive Surgery Columbus, OH

More Trial Locations

Who Is Running the Clinical Trial?

Checkpoint Surgical Inc. Lead Sponsor

Congressionally Directed Medical Research Programs Collaborator

References