Clinical trial NCT04662320: Promoting Healing of Nerves Through Electrical Stimulation
Official title: Promoting Healing of Nerves Through Electrical Stimulation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cubital Tunnel Syndrome
Nerve Compression
Nerve Injury
Ulnar Neuropathies
Keywords: Therapeutic Electrical Stimulation
Nerve Regeneration
Nerve Healing
Nerve Injury
Cubital Tunnel
Ulnar Nerve
Lead sponsor: Checkpoint Surgical Inc.
Sponsor class: INDUSTRY
Collaborators: name: Congressionally Directed Medical Research Programs
First posted: 2020-12-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Grip Strength at 1 year.
timeFrame: 1 year
Secondary outcomes:
measure: Grip Strength
timeFrame: Pre-surgery, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year
measure: Lateral Pinch Strength
timeFrame: Pre-surgery, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year
measure: 2-point discrimination
timeFrame: Pre-surgery, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year
measure: Semmes-Weinstein Monofilament Testing
timeFrame: Pre-surgery, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year
measure: Medical Research Council (MRC) motor grading.
timeFrame: Pre-surgery, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year
measure: Maximal finger spread measurement.
timeFrame: Pre-surgery, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year
measure: Patient Reported Outcome Measurement System (PROMIS) Upper Extremity Function
timeFrame: Pre-surgery, 10 days, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year
measure: Patient Reported Outcome Measurement System (PROMIS) Pain Interference
timeFrame: Pre-surgery, 10 days, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year
measure: Michigan Hand Questionnaire (MHQ)
timeFrame: Pre-surgery, 10 days, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year
measure: Nerve Conduction Velocity (NCV)
timeFrame: Pre-surgery, 3 months, and 7 months
measure: Electromyography (EMG)
timeFrame: Pre-surgery, 3 months, and 7 months
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
city: Chicago
country: United States
facility: Northwestern Feinberg School of Medicine - Department of Orthopaedic Surgery
state: Illinois
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
city: Columbus
country: United States
facility: The Ohio State Univeristy - Department of Plastic and Reconstructive Surgery
state: Ohio
city: Milwaukee
country: United States
facility: Medical College of Wisconsin - Hand Center
state: Wisconsin
Study officials:
affiliation: The Ohio State Univeristy Department of Plastic and Reconstructive Surgery
name: Amy M Moore, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Saffari TM, Walker ER, Pet MA, Moore AM. Brief Intraoperative Electrical Stimulation to Enhance Nerve Regeneration. Plast Reconstr Surg Glob Open. 2024 Apr 10;12(4):e5730. doi: 10.1097/GOX.0000000000005730. eCollection 2024 Apr. No abstract available.
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.
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.
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.
citation: 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). 2023 Mar;18(2):203-213. doi: 10.1177/1558944721998022. Epub 2021 Apr 2.
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.
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.