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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
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
Stanford University
Stanford, California, United States
Northwestern Feinberg School of Medicine - Department of Orthopaedic Surgery
Chicago, Illinois, United States
Washington University in St. Louis
St Louis, Missouri, United States
The Ohio State Univeristy - Department of Plastic and Reconstructive Surgery
Columbus, Ohio, United States
Change in Grip Strength at 1 year.
Change in grip strength at 1 year from baseline (pre-operative) assessment.
Time frame: 1 year
Grip Strength
Maximum grip strength
Time frame: Pre-surgery, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year
Lateral Pinch Strength
Maximum lateral pinch strength
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Pre-surgery, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year
Maximal finger spread measurement.
Measurement of maximal finger spread.
Time frame: Pre-surgery, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year
Patient Reported Outcome Measurement System (PROMIS) Upper Extremity Function
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Medical College of Wisconsin - Hand Center
Milwaukee, Wisconsin, United States
Questionnaire providing patient reported estimate of upper extremity function on a 0-100 scale with \>50 representing greater normal function.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Pre-surgery, 3 months, and 7 months
Electromyography (EMG)
Measurement of the electrical activity in a muscle.
Time frame: Pre-surgery, 3 months, and 7 months