Nerve Injury Clinical Trial
— PHONESOfficial title:
Promoting Healing Of Nerves Through Electrical Stimulation
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 2025 |
Est. primary completion date | December 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Northwestern Feinberg School of Medicine - Department of Orthopaedic Surgery | Chicago | Illinois |
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 | Washington University in St. Louis | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Checkpoint Surgical Inc. | Congressionally Directed Medical Research Programs |
United States,
Evans A, Padovano WM, Patterson JMM, Wood MD, Fongsri W, Kennedy CR, Mackinnon SE. Beyond the Cubital Tunnel: Use of Adjunctive Procedures in the Management of Cubital Tunnel Syndrome. Hand (N Y). 2021 Apr 2:1558944721998022. doi: 10.1177/1558944721998022. Online ahead of print. — View Citation
Gordon T, Amirjani N, Edwards DC, Chan KM. Brief post-surgical electrical stimulation accelerates axon regeneration and muscle reinnervation without affecting the functional measures in carpal tunnel syndrome patients. Exp Neurol. 2010 May;223(1):192-202. doi: 10.1016/j.expneurol.2009.09.020. Epub 2009 Oct 1. — View Citation
Jo S, Pan D, Halevi AE, Roh J, Schellhardt L, Hunter Ra DA, Snyder-Warwick AK, Moore AM, Mackinnon SE, Wood MD. Comparing electrical stimulation and tacrolimus (FK506) to enhance treating nerve injuries. Muscle Nerve. 2019 Nov;60(5):629-636. doi: 10.1002/mus.26659. Epub 2019 Aug 21. — View Citation
Power HA, Morhart MJ, Olson JL, Chan KM. Postsurgical Electrical Stimulation Enhances Recovery Following Surgery for Severe Cubital Tunnel Syndrome: A Double-Blind Randomized Controlled Trial. Neurosurgery. 2020 Jun 1;86(6):769-777. doi: 10.1093/neuros/nyz322. — View Citation
Roh J, Schellhardt L, Keane GC, Hunter DA, Moore AM, Snyder-Warwick AK, Mackinnon SE, Wood MD. Short-Duration, Pulsatile, Electrical Stimulation Therapy Accelerates Axon Regeneration and Recovery following Tibial Nerve Injury and Repair in Rats. Plast Reconstr Surg. 2022 Apr 1;149(4):681e-690e. doi: 10.1097/PRS.0000000000008924. — View Citation
Sayanagi J, Acevedo-Cintron JA, Pan D, Schellhardt L, Hunter DA, Snyder-Warwick AK, Mackinnon SE, Wood MD. Brief Electrical Stimulation Accelerates Axon Regeneration and Promotes Recovery Following Nerve Transection and Repair in Mice. J Bone Joint Surg Am. 2021 Oct 20;103(20):e80. doi: 10.2106/JBJS.20.01965. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Grip Strength at 1 year. | Change in grip strength at 1 year from baseline (pre-operative) assessment. | 1 year | |
Secondary | Grip Strength | Maximum grip strength | Pre-surgery, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year | |
Secondary | Lateral Pinch Strength | Maximum lateral pinch strength | Pre-surgery, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Maximal finger spread measurement. | Measurement of maximal finger spread. | Pre-surgery, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Nerve Conduction Velocity (NCV) | Measurement of how quickly an electrical impulse moves along the nerve. | Pre-surgery, 3 months, and 7 months | |
Secondary | Electromyography (EMG) | Measurement of the electrical activity in a muscle. | Pre-surgery, 3 months, and 7 months |
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