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NCT Number: NCT05884125

Promoting Healing of Injured Nerves With Electrical Stimulation Therapy

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.

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Key information

Conditions

Nerve Injury Nerve Palsy Nervous System Diseases Neuromuscular Diseases Peripheral Nerve Injuries Peripheral Nerve Injury Upper Limb Peripheral Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Ohio State Univeristy - Department of Plastic and Reconstructive Surgery

Columbus, Ohio, 43212, United States

Location status: Recruiting

Location contact

Amy M Moore, MD

PRINCIPAL_INVESTIGATOR

Research Coordinator

CONTACT

[email protected]

614-293-8566

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Checkpoint BEST System

Device

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 names: Brief Electrical Stimulation (BES) Therapy

Primary outcomes

  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 outcomes

  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.

Study contacts

Contact information is provided by the study sponsor or research team.

Eric Walker, PhD

CONTACT

[email protected]

216-370-9107 ext. 101

Sponsors and collaborators

Lead sponsor

Checkpoint Surgical Inc.

Industry

Collaborators

  • Congressionally Directed Medical Research Programs

Registry information

Acronym: PHINEST

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jun 1, 2023
Registry last updated
Aug 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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