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Trial record 2 of 2 for:    PHINEST

Promoting Healing of Injured Nerves With Electrical Stimulation Therapy (PHINEST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05884125
Recruitment Status : Recruiting
First Posted : June 1, 2023
Last Update Posted : June 13, 2023
Sponsor:
Collaborator:
Congressionally Directed Medical Research Programs
Information provided by (Responsible Party):
Checkpoint Surgical Inc.

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 peripheral nerve injury in arm. Participants will be randomized into one of two groups, treatment or control, with all participants receiving standard of care treatment for the nerve injury. The treatment group will also receive a single dose of the therapeutic stimulation during the surgical intervention for their nerve injury.

Condition or disease Intervention/treatment Phase
Nerve Injury Peripheral Nerve Injuries Peripheral Nerve Injury Upper Limb Nerve Palsy 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 pilot 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 peripheral nerve injury in the arm.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Promoting Healing of Injured Nerves With Electrical Stimulation Therapy
Actual Study Start Date : June 12, 2023
Estimated Primary Completion Date : June 2027
Estimated Study Completion Date : June 2027

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Brief Electrical Stimulation Therapy
Single, 10 minute dose of electrical stimulation delivered to the injured nerve during surgical intervention.
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: Brief Electrical Stimulation (BES) Therapy

No Intervention: Standard of Care
Surgical intervention for repair of peripheral nerve injury.



Primary Outcome Measures :
  1. Change in Motor Recovery assessed using the Medical Research Council (MRC) motor grading [ Time Frame: Pre-surgery, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months ]
    Grading of muscle strength on 0 to 5 scale, with higher score representing greater function.


Secondary Outcome Measures :
  1. Grip Strength [ Time Frame: Pre-surgery, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months ]
    Maximum grip strength.

  2. Lateral Pinch Strength [ Time Frame: Pre-surgery, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months ]
    Maximum lateral pinch.

  3. 2-point discrimination [ Time Frame: Pre-surgery, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months ]
    Evaluation of sensory function, measuring tactile discrimination.

  4. Semmes-Weinstein Monofilament Testing [ Time Frame: Pre-surgery, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months ]
    Evaluation of sensory function, measuring pressure detection threshold.

  5. Patient Reported Outcome Measurement System (PROMIS) Upper Extremity Function [ Time Frame: Pre-surgery, 10 days, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months ]
    Questionnaire providing patient reported estimate of upper extremity function on a 0-100 scale with >50 representing greater normal function.

  6. Patient Reported Outcome Measurement System (PROMIS) Pain Interference [ Time Frame: Pre-surgery, 10 days, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months ]
    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.

  7. quick Disabilities of thee Arm, Shoulder, and Hand (DASH) questionnaire [ Time Frame: Pre-surgery, 10 days, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months ]
    Questionnaire providing patient reported estimate upper extremity function. The score ranges from 0 (no disability) to 100 (most severe disability).

  8. Electromyography (EMG) [ Time Frame: 4 months, 6 months, and 8 months ]
    Measurement of the electrical activity in a muscle.

  9. Motor Unit Number Estimation (MUNE) [ Time Frame: 4 months, 6 months, and 8 months ]
    Estimate of the number of motor units within the muscle based on recorded electrical activity.



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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:

  • Upper extremity mixed or motor nerve injury from the brachial plexus to the wrist crease.
  • Candidate for surgical intervention.
  • Indicated for surgical repair by nerve transfer, primary repair, or nerve grafting.
  • Are age 18-80 years.
  • Signed and dated informed consent form.

Exclusion Criteria:

  • Severe comorbid condition, such as arrhythmia or congestive heart failure, preventing surgery.
  • Primary repair requiring graft >6cm.
  • Nerve reconstruction occurring >12 months post injury.
  • Age less than 18 or greater than 80 years.
  • All contraindications to included/required surgical procedure, including but not limited to language barriers, mental status barriers, inability to consent, and pregnancy/lactation.

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): NCT05884125


Contacts
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Contact: Eric Walker, PhD 216-370-9107 ext 101 ewalker@checkpointsurgical.com

Locations
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United States, Illinois
Northwestern Feinberg School of Medicine - Department of Orthopaedic Surgery Not yet recruiting
Chicago, Illinois, United States, 60611
Contact: Clinical Research Coordinator    312-695-4463    orthosurveys@nm.org   
Principal Investigator: Jason Ko, 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         
Sponsors and Collaborators
Checkpoint Surgical Inc.
Congressionally Directed Medical Research Programs
Investigators
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Principal Investigator: Amy M Moore, MD Ohio State University
Publications:

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Responsible Party: Checkpoint Surgical Inc.
ClinicalTrials.gov Identifier: NCT05884125    
Other Study ID Numbers: 0153-CSP-002
W81XWH1920065 ( Other Grant/Funding Number: Department of Defense USAMRAA )
First Posted: June 1, 2023    Key Record Dates
Last Update Posted: June 13, 2023
Last Verified: June 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
Brief Electrical Stimulation
Nerve Regeneration
Nerve Injury
Nerve Healing
Nerve Repair
Additional relevant MeSH terms:
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Peripheral Nerve Injuries
Wounds and Injuries
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Trauma, Nervous System