Promoting Healing of Nerves Through Electrical Stimulation
- Conditions
- Nerve InjuryUlnar NeuropathiesCubital Tunnel SyndromeNerve Compression
- Interventions
- Device: Checkpoint BEST System
- Registration Number
- NCT04662320
- Lead Sponsor
- 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 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
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Brief Electrical Stimulation Checkpoint BEST System Single, 10 minute dose of electrical stimulation delivered to the ulnar nerve during surgical intervention for cubital tunnel decompression.
- Primary Outcome Measures
Name Time Method Change in Grip Strength at 1 year. 1 year Change in grip strength at 1 year from baseline (pre-operative) assessment.
- Secondary Outcome Measures
Name Time Method Medical Research Council (MRC) motor grading. 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.
Patient Reported Outcome Measurement System (PROMIS) Upper Extremity Function 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.
Michigan Hand Questionnaire (MHQ) 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.
Lateral Pinch Strength Pre-surgery, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year Maximum lateral pinch strength
2-point discrimination Pre-surgery, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year Evaluation of sensory function, measuring tactile discrimination.
Patient Reported Outcome Measurement System (PROMIS) Pain Interference 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.
Electromyography (EMG) Pre-surgery, 3 months, and 7 months Measurement of the electrical activity in a muscle.
Grip Strength Pre-surgery, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year Maximum grip strength
Semmes-Weinstein Monofilament Testing Pre-surgery, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year Evaluation of sensory function, measuring pressure detection threshold.
Maximal finger spread measurement. Pre-surgery, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year Measurement of maximal finger spread.
Nerve Conduction Velocity (NCV) Pre-surgery, 3 months, and 7 months Measurement of how quickly an electrical impulse moves along the nerve.
Trial Locations
- Locations (5)
Stanford University
🇺🇸Stanford, California, United States
Northwestern Feinberg School of Medicine - Department of Orthopaedic Surgery
🇺🇸Chicago, Illinois, United States
Washington University in St. Louis
🇺🇸Saint Louis, Missouri, United States
The Ohio State Univeristy - Department of Plastic and Reconstructive Surgery
🇺🇸Columbus, Ohio, United States
Medical College of Wisconsin - Hand Center
🇺🇸Milwaukee, Wisconsin, United States