Promoting Healing of Nerves Through Electrical Stimulation (PHONES)

December 3, 2024 updated by: Checkpoint Surgical Inc.
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Preliminary research has shown that delivering a brief period of electrical stimulation following nerve repair promotes nerve healing and functional recovery. This study is investigating the use of a single dose of therapeutic electrical stimulation to promote nerve healing. The therapy is delivered as part of the surgical intervention to address compression of the ulnar nerve at the elbow, commonly referred to as Cubital Tunnel Syndrome.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94304
        • Stanford University
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Feinberg School of Medicine - Department of Orthopaedic Surgery
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University in St. Louis
    • Ohio
      • Columbus, Ohio, United States, 43212
        • The Ohio State Univeristy - Department of Plastic and Reconstructive Surgery
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin - Hand Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Electrodiagnostic evidence of ulnar neuropathy at the elbow.
  • Are candidates for surgical intervention.
  • Evidence of motor involvement such as intrinsic muscle atrophy or weakness.
  • Are age 18-80 years.
  • Signed and dated informed consent form.

Exclusion Criteria:

  • Severe comorbid condition, such as arrythmia or congestive heart failure, preventing surgery
  • Previous history or current transection of ulnar nerve, or concomitant upper extremity nerve injury
  • Global peripheral neuropathy affecting the hands
  • Age less than 18 or greater than 80 years
  • Un-affected hand maximum grip strength <12kg

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Brief Electrical Stimulation
Single, 10 minute dose of electrical stimulation delivered to the ulnar nerve during surgical intervention for cubital tunnel decompression.
Device: Checkpoint BEST System

Single use medical device, consisting of electric stimulator and intraoperative lead. Therapy consists of single, 10 minute dose delivered proximal to site of decompression/repair.

Other Name: Checkpoint BEST System

Other Names:
  • Brief Electrical Stimulation (BES) Therapy
No Intervention: Standard of Care
Surgical intervention for cubital tunnel decompression.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Grip Strength at 1 year.
Time Frame: 1 year
Change in grip strength at 1 year from baseline (pre-operative) assessment.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Grip Strength
Time Frame: Pre-surgery, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year
Maximum grip strength
Pre-surgery, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year
Lateral Pinch Strength
Time Frame: Pre-surgery, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year
Maximum lateral pinch strength
Pre-surgery, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year
2-point discrimination
Time Frame: Pre-surgery, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year
Evaluation of sensory function, measuring tactile discrimination.
Pre-surgery, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year
Semmes-Weinstein Monofilament Testing
Time Frame: Pre-surgery, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year
Evaluation of sensory function, measuring pressure detection threshold.
Pre-surgery, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year
Medical Research Council (MRC) motor grading.
Time Frame: Pre-surgery, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year
Grading of muscle strength on 0 to 5 scale, with higher score representing greater function.
Pre-surgery, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year
Maximal finger spread measurement.
Time Frame: Pre-surgery, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year
Measurement of maximal finger spread.
Pre-surgery, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year
Patient Reported Outcome Measurement System (PROMIS) Upper Extremity Function
Time Frame: Pre-surgery, 10 days, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year
Questionnaire providing patient reported estimate of upper extremity function on a 0-100 scale with >50 representing greater normal function.
Pre-surgery, 10 days, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year
Patient Reported Outcome Measurement System (PROMIS) Pain Interference
Time Frame: Pre-surgery, 10 days, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year
Questionnaire providing patient reported estimate of interference of pain on daily activities on a 0-100 scale with >50 representing greater than normal pain interference on daily activities.
Pre-surgery, 10 days, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year
Michigan Hand Questionnaire (MHQ)
Time Frame: Pre-surgery, 10 days, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year
MHQ is a patient reported estimate of hand function on a 0-100 scale with a higher number indication greater hand function.
Pre-surgery, 10 days, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year
Nerve Conduction Velocity (NCV)
Time Frame: Pre-surgery, 3 months, and 7 months
Measurement of how quickly an electrical impulse moves along the nerve.
Pre-surgery, 3 months, and 7 months
Electromyography (EMG)
Time Frame: Pre-surgery, 3 months, and 7 months
Measurement of the electrical activity in a muscle.
Pre-surgery, 3 months, and 7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Checkpoint Surgical Inc.

Collaborators

Congressionally Directed Medical Research Programs

Investigators

  • Principal Investigator: Amy M Moore, MD, The Ohio State Univeristy Department of Plastic and Reconstructive Surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

November 24, 2020

First Submitted That Met QC Criteria

December 4, 2020

First Posted (Actual)

December 10, 2020

Study Record Updates

Last Update Posted (Actual)

December 5, 2024

Last Update Submitted That Met QC Criteria

December 3, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0153-CSP-001
  • W81XWH1920065 (Other Grant/Funding Number: Department of Defense USAMRAA)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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