Promoting Healing of Injured Nerves With Electrical Stimulation Therapy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Promoting Healing of Injured Nerves With Electrical Stimulation Therapy

Conditions
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Nerve Injury, Peripheral Nerve Injuries, Peripheral Nerve Injury Upper Limb, Nerve Palsy

Intervention / Treatment
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* Device: Checkpoint BEST System


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brief Electrical Stimulation Therapy<br>Single, 10 minute dose of electrical stimulation delivered to the injured nerve during surgical intervention. | Device: Checkpoint BEST System<br>* 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<br>* Other names: Brief Electrical Stimulation (BES) Therapy;|
| No Intervention: Standard of Care<br>Surgical intervention for repair of peripheral nerve injury. | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Grip Strength | Maximum grip strength. | Pre-surgery, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months | 
| Lateral Pinch Strength | Maximum lateral pinch. | Pre-surgery, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months | 
| 2-point discrimination | Evaluation of sensory function, measuring tactile discrimination. | Pre-surgery, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months | 
| Semmes-Weinstein Monofilament Testing | Evaluation of sensory function, measuring pressure detection threshold. | Pre-surgery, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months | 
| Patient Reported Outcome Measurement System (PROMIS) Upper Extremity Function | Questionnaire providing patient reported estimate of upper extremity function on a 0-100 scale with >50 representing greater normal function. | Pre-surgery, 10 days, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months | 
| Patient Reported Outcome Measurement System (PROMIS) Pain Interference | 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, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months | 
| quick Disabilities of thee Arm, Shoulder, and Hand (DASH) questionnaire | Questionnaire providing patient reported estimate upper extremity function. The score ranges from 0 (no disability) to 100 (most severe disability). | Pre-surgery, 10 days, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months | 
| Electromyography (EMG) | Measurement of the electrical activity in a muscle. | 4 months, 6 months, and 8 months | 
| Motor Unit Number Estimation (MUNE) | Estimate of the number of motor units within the muscle based on recorded electrical activity. | 4 months, 6 months, and 8 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Therapeutic Electrical Stimulation, Brief Electrical Stimulation, Nerve Regeneration, Nerve Injury, Nerve Healing, Nerve Repair