Promoting Healing Of Nerves Through Electrical Stimulation

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 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.

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 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.

Official Title
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Promoting Healing Of Nerves Through Electrical Stimulation

Conditions
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Cubital Tunnel Syndrome, Nerve Compression, Nerve Injury, Ulnar Neuropathies

Intervention / Treatment
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* Device: Checkpoint BEST System


Participation Criteria
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Eligibility Criteria
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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

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<br>Single, 10 minute dose of electrical stimulation delivered to the ulnar nerve during surgical intervention for cubital tunnel decompression. | 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. Other Name: Checkpoint BEST System<br>* Other names: Brief Electrical Stimulation (BES) Therapy;|
| No Intervention: Standard of Care<br>Surgical intervention for cubital tunnel decompression. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Grip Strength at 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 | Maximum grip strength | Pre-surgery, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year | 
| Lateral Pinch Strength | Maximum lateral pinch strength | Pre-surgery, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year | 
| 2-point discrimination | 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 | 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. | 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. | 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 | 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 | 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) | 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) | Measurement of how quickly an electrical impulse moves along the nerve. | Pre-surgery, 3 months, and 7 months | 
| Electromyography (EMG) | Measurement of the electrical activity in a muscle. | Pre-surgery, 3 months, and 7 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Therapeutic Electrical Stimulation, Nerve Regeneration, Nerve Healing, Nerve Injury, Cubital Tunnel, Ulnar Nerve