Promoting Healing Of Nerves Through Electrical Stimulation (PHONES)

• ClinicalTrials.gov Identifier: NCT04662320
• Recruitment Status: Recruiting
• First Posted: December 10, 2020
• Last Update Posted: March 22, 2023
• Sponsor: Checkpoint Surgical Inc.
• Collaborator: Congressionally Directed Medical Research Programs
• Information provided by (Responsible Party): Checkpoint Surgical Inc.

Tracking Information

• First Submitted Date: November 24, 2020
• First Posted Date: December 10, 2020
• Last Update Posted Date: March 22, 2023
• Actual Study Start Date: September 1, 2021
• Estimated Primary Completion Date: December 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 4, 2020)

Change in Grip Strength at 1 year. [ Time Frame: 1 year ]

Change in grip strength at 1 year from baseline (pre-operative) assessment.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: December 4, 2020)

• Grip Strength [ Time Frame: Pre-surgery, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year ]
  Maximum grip strength
• Lateral Pinch Strength [ Time Frame: Pre-surgery, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year ]
  Maximum lateral pinch strength
• 2-point discrimination [ Time Frame: Pre-surgery, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year ]
  Evaluation of sensory function, measuring tactile discrimination.
• Semmes-Weinstein Monofilament Testing [ Time Frame: Pre-surgery, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year ]
  Evaluation of sensory function, measuring pressure detection threshold.
• Medical Research Council (MRC) motor grading. [ Time Frame: 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.
• Maximal finger spread measurement. [ Time Frame: Pre-surgery, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year ]
  Measurement of maximal finger spread.
• Patient Reported Outcome Measurement System (PROMIS) Upper Extremity Function [ Time Frame: 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.
• Patient Reported Outcome Measurement System (PROMIS) Pain Interference [ Time Frame: 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.
• Michigan Hand Questionnaire (MHQ) [ Time Frame: 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.
• Nerve Conduction Velocity (NCV) [ Time Frame: Pre-surgery, 3 months, and 7 months ]
  Measurement of how quickly an electrical impulse moves along the nerve.
• Electromyography (EMG) [ Time Frame: Pre-surgery, 3 months, and 7 months ]
  Measurement of the electrical activity in a muscle.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Promoting Healing Of Nerves Through Electrical Stimulation
• Official Title: Promoting Healing Of Nerves Through Electrical Stimulation
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Outcomes Assessor); Primary Purpose: Treatment

Condition

• 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

Other Name: Brief Electrical Stimulation (BES) Therapy

Study Arms

• Experimental: Brief Electrical Stimulation
  Single, 10 minute dose of electrical stimulation delivered to the ulnar nerve during surgical intervention for cubital tunnel decompression.
  Intervention: Device: Checkpoint BEST System
• No Intervention: Standard of Care
  Surgical intervention for cubital tunnel decompression.

Publications *

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: December 4, 2020): 100
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2025
• Estimated Primary Completion Date: December 2025 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Eric Walker, PhD; 216-378-9107 ext 101; ewalker@checkpointsurgical.com

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04662320
• Other Study ID Numbers: 0153-CSP-001; W81XWH1920065 ( Other Grant/Funding Number: Department of Defense USAMRAA )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Checkpoint Surgical Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Checkpoint Surgical Inc.
• Original Study Sponsor: Same as current
• Collaborators: Congressionally Directed Medical Research Programs

Investigators

• Principal Investigator: Amy M Moore, MD; The Ohio State Univeristy Department of Plastic and Reconstructive Surgery

• PRS Account: Checkpoint Surgical Inc.
• Verification Date: March 2023