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Promoting Healing Of Nerves Through Electrical Stimulation (PHONES)

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ClinicalTrials.gov Identifier: NCT04662320
Recruitment Status : Recruiting
First Posted : December 10, 2020
Last Update Posted : March 22, 2023
Sponsor:
Collaborator:
Congressionally Directed Medical Research Programs
Information provided by (Responsible Party):
Checkpoint Surgical Inc.

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cubital Tunnel Syndrome Nerve Compression Nerve Injury Ulnar Neuropathies Device: Checkpoint BEST System Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Promoting Healing Of Nerves Through Electrical Stimulation
Actual Study Start Date : September 1, 2021
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: Brief Electrical Stimulation (BES) Therapy
No Intervention: Standard of Care
Surgical intervention for cubital tunnel decompression.


Outcome Measures
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Primary Outcome Measures :
  1. Change in Grip Strength at 1 year. [ Time Frame: 1 year ]
    Change in grip strength at 1 year from baseline (pre-operative) assessment.


Secondary Outcome Measures :
  1. Grip Strength [ Time Frame: Pre-surgery, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year ]
    Maximum grip strength

  2. Lateral Pinch Strength [ Time Frame: Pre-surgery, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year ]
    Maximum lateral pinch strength

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. Nerve Conduction Velocity (NCV) [ Time Frame: Pre-surgery, 3 months, and 7 months ]
    Measurement of how quickly an electrical impulse moves along the nerve.

  11. Electromyography (EMG) [ Time Frame: Pre-surgery, 3 months, and 7 months ]
    Measurement of the electrical activity in a muscle.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04662320


Contacts
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Contact: Eric Walker, PhD 216-378-9107 ext 101 ewalker@checkpointsurgical.com

Locations
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United States, Illinois
Northwestern Feinberg School of Medicine - Department of Orthopaedic Surgery Recruiting
Chicago, Illinois, United States, 60611
Contact: Clinical Research Coordinator    312-695-4463    orthosurveys@nm.org   
Principal Investigator: Jason Ko, MD         
United States, Missouri
Washington University in St. Louis Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Clinical Reseach Coordinator    314-454-5967      
Principal Investigator: David Brogan, MD         
Sub-Investigator: Christopher Dy, MD         
United States, Ohio
The Ohio State Univeristy - Department of Plastic and Reconstructive Surgery Recruiting
Columbus, Ohio, United States, 43212
Contact: Research Coordinator    614-293-8566    nervenerds@osumc.edu   
Principal Investigator: Amy M Moore, MD         
Sub-Investigator: Hisham Awan, MD         
Sub-Investigator: Sonu Jain, MD         
Sub-Investigator: Kanu Goyal, MD         
Sub-Investigator: Ryan Schmucker, MD         
Sub-Investigator: Amy Speeckaert, MD         
Sub-Investigator: Ronald Brown, MD         
Sub-Investigator: Jill Putnam, MD         
United States, Wisconsin
Medical College of Wisconsin - Hand Center Recruiting
Milwaukee, Wisconsin, United States, 53226
Principal Investigator: Gwendolyn Hoben, MD, PhD         
Sponsors and Collaborators
Checkpoint Surgical Inc.
Congressionally Directed Medical Research Programs
Investigators
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Principal Investigator: Amy M Moore, MD The Ohio State Univeristy Department of Plastic and Reconstructive Surgery
More Information
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Publications:

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Responsible Party: Checkpoint Surgical Inc.
ClinicalTrials.gov Identifier: NCT04662320    
Other Study ID Numbers: 0153-CSP-001
W81XWH1920065 ( Other Grant/Funding Number: Department of Defense USAMRAA )
First Posted: December 10, 2020    Key Record Dates
Last Update Posted: March 22, 2023
Last Verified: March 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Checkpoint Surgical Inc.:
Therapeutic Electrical Stimulation
Nerve Regeneration
Nerve Healing
 Nerve Injury
Cubital Tunnel
Ulnar Nerve
Additional relevant MeSH terms:
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Cubital Tunnel Syndrome
Ulnar Neuropathies
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
 Ulnar Nerve Compression Syndromes
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries