Promoting Healing of Nerves Through Electrical Stimulation

NCT04662320 | Active Not Recruiting FDA Device

• 2 other identifiers: 0153-CSP-001W81XWH1920065
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 5

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.

Conditions

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

Keywords

Therapeutic Electrical Stimulation; Nerve Regeneration; Nerve Healing; Nerve Injury; Cubital Tunnel; Ulnar Nerve

Outcome Measures

Primary Outcomes (1)

• Change in Grip Strength at 1 year.

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

  1 year

Secondary Outcomes (11)

• Grip Strength

  Pre-surgery, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year

• Lateral Pinch Strength

  Pre-surgery, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year

• 2-point discrimination

  Pre-surgery, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year

• Semmes-Weinstein Monofilament Testing

  Pre-surgery, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year

• Medical Research Council (MRC) motor grading.

  Pre-surgery, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year

Study Arms (2)

Brief Electrical Stimulation

EXPERIMENTAL

Single, 10 minute dose of electrical stimulation delivered to the ulnar nerve during surgical intervention for cubital tunnel decompression.

Device: Checkpoint BEST System

Standard of Care

NO INTERVENTION

Surgical intervention for cubital tunnel decompression.

Interventions

Checkpoint BEST System DEVICE

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

Also known as: Brief Electrical Stimulation (BES) Therapy

Brief Electrical Stimulation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Checkpoint Surgical Inc.: lead
• Congressionally Directed Medical Research Programs: collaborator

Study Sites (5)

Stanford University

Stanford, California, 94304, United States

Location

Northwestern Feinberg School of Medicine - Department of Orthopaedic Surgery

Chicago, Illinois, 60611, United States

Location

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

The Ohio State Univeristy - Department of Plastic and Reconstructive Surgery

Columbus, Ohio, 43212, United States

Location

Medical College of Wisconsin - Hand Center

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (7)

• 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.

  PMID: 38600968 BACKGROUND

• 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.

  PMID: 31432080 BACKGROUND

• 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.

  PMID: 19800329 BACKGROUND

• 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.

  PMID: 31397919 BACKGROUND

• 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.

  PMID: 33794683 BACKGROUND

• 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.

  PMID: 34668879 BACKGROUND

• 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.

  PMID: 35139047 BACKGROUND

MeSH Terms

Conditions

Cubital Tunnel Syndrome; Neuroma; Ulnar Neuropathies

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Ulnar Nerve Compression Syndromes; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Amy M Moore, MD

  The Ohio State Univeristy Department of Plastic and Reconstructive Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2020
• First Posted: December 10, 2020
• Study Start: September 1, 2021
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 5, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)