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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
PHONES Trial 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.Check my eligibility
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.See study design
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.
PHONES Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 80 years old.
Select...
I have muscle weakness or shrinkage.
PHONES Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Grip Strength at 1 year.
Secondary outcome measures
2-point discrimination
Electromyography (EMG)
Grip Strength
+8 morePHONES 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.
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Who is running the clinical trial?
Congressionally Directed Medical Research ProgramsFED
48 Previous Clinical Trials
6,676 Total Patients Enrolled
1 Trials studying Nerve Injury
60 Patients Enrolled for Nerve Injury
Checkpoint Surgical Inc.Lead Sponsor
1 Previous Clinical Trials
60 Total Patients Enrolled
1 Trials studying Nerve Injury
60 Patients Enrolled for Nerve Injury
Amy M Moore, MDPrincipal InvestigatorThe Ohio State Univeristy Department of Plastic and Reconstructive Surgery
1 Previous Clinical Trials
60 Total Patients Enrolled
1 Trials studying Nerve Injury
60 Patients Enrolled for Nerve Injury
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am younger than 18 or older than 80.I experience numbness or pain in my hands.I am between 18 and 80 years old.I am eligible for surgery.My unaffected hand's grip strength is under 12kg.I have muscle weakness or shrinkage.I have a serious health condition like heart failure that prevents me from having surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Standard of Care
- Group 2: Brief Electrical Stimulation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the enrollment for this clinical trial open at present?
"Affirmative. According to clinicaltrials.gov, the trial which began on September 1st 2021 is presently recruiting participants. A total of 100 individuals are needed from 3 different sites."
Answered by AI
How many participants are taking part in this trial?
"The trial sponsor, Checkpoint Surgical Inc., is seeking 100 compliant patients to complete the study. These patients will be observed at The Ohio State University's Department of Plastic and Reconstructive Surgery in Columbus, Ohio as well as Medical College of Wisconsin's Hand Center in Milwaukee, Wisconsin."
Answered by AI
Is eligibility for this clinical trial limited to adults?
"This research project is enrolling adults aged 18 years or older but younger than 80."
Answered by AI
What demographic is best suited for recruitment in this trial?
"Candidates aged between 18 and 80 years old with a diagnosis of ulnar neuritis may be eligible to join this clinical trial, which is in need of approximately one hundred participants."
Answered by AI
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