Promoting Healing Of Nerves Through Electrical Stimulation

Nerve Injury Clinical Trial

— PHONES  

Official title:

Promoting Healing Of Nerves Through Electrical Stimulation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04662320
• Other study ID #: 0153-CSP-001
• Secondary ID: W81XWH1920065
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: December 2025

Study information

• Verified date: March 2023
• Source: Checkpoint Surgical Inc.
• Contact: Eric Walker, PhD
• Phone: 216-378-9107
• Email: ewalker[@]checkpointsurgical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• 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

Related Conditions & MeSH terms

• Cubital Tunnel Syndrome
• Nerve Compression
• Nerve Injury
• Ulnar Neuropathies

Intervention

Device:
• Checkpoint BEST System
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

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Checkpoint Surgical Inc.	Congressionally Directed Medical Research Programs

Country where clinical trial is conducted

United States, 

References & Publications (6)

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

Outcome

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