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Electrical Stimulation

Electrical Stimulation for Cubital Tunnel Syndrome (PHONES Trial)

N/A
Recruiting
Led By Amy M Moore, MD
Research Sponsored by Checkpoint Surgical Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18-80 years
Evidence of motor involvement such as intrinsic muscle atrophy or weakness
Must not have
Age less than 18 or greater than 80 years
Global peripheral neuropathy affecting the hands
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new electrical stimulation therapy to help nerves heal and improve function after surgery for nerve compression. The stimulation is given during surgery for ulnar nerve compression at the elbow.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include discomfort at the stimulation site, temporary increased nerve pain or tingling sensations post-surgery due to electrical stimulation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 80 years old.
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I have muscle weakness or shrinkage.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am younger than 18 or older than 80.
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I experience numbness or pain in my hands.
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My unaffected hand's grip strength is under 12kg.
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I have a serious health condition like heart failure that prevents me from having surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Grip Strength at 1 year.
Secondary study objectives
2-point discrimination
Electromyography (EMG)
Grip Strength
+8 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Brief Electrical StimulationExperimental Treatment1 Intervention
Single, 10 minute dose of electrical stimulation delivered to the ulnar nerve during surgical intervention for cubital tunnel decompression.
Group II: Standard of CareActive Control1 Intervention
Surgical intervention for cubital tunnel decompression.

Find a Location

Who is running the clinical trial?

Congressionally Directed Medical Research ProgramsFED
56 Previous Clinical Trials
10,229 Total Patients Enrolled
Checkpoint Surgical Inc.Lead Sponsor
1 Previous Clinical Trials
60 Total Patients Enrolled
Amy M Moore, MDPrincipal InvestigatorThe Ohio State Univeristy Department of Plastic and Reconstructive Surgery
1 Previous Clinical Trials
60 Total Patients Enrolled

Media Library

Checkpoint BEST System (Electrical Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT04662320 — N/A
Ulnar Neuropathy Research Study Groups: Standard of Care, Brief Electrical Stimulation
Ulnar Neuropathy Clinical Trial 2023: Checkpoint BEST System Highlights & Side Effects. Trial Name: NCT04662320 — N/A
Checkpoint BEST System (Electrical Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04662320 — N/A
~24 spots leftby Dec 2025
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