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Promoting Healing of Nerves Through Electrical Stimulation

NCT ID: NCT04662320

Last Updated: 2024-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Cubital Tunnel Syndrome Nerve Compression Nerve Injury Ulnar Neuropathies

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Brief Electrical Stimulation

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

Group Type EXPERIMENTAL

Checkpoint BEST System

Intervention Type 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

Standard of Care

Surgical intervention for cubital tunnel decompression.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type DEVICE

Other Intervention Names

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Brief Electrical Stimulation (BES) Therapy

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Congressionally Directed Medical Research Programs

FED

Sponsor Role collaborator

Checkpoint Surgical Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Amy M Moore, MD

Role: PRINCIPAL_INVESTIGATOR

The Ohio State Univeristy Department of Plastic and Reconstructive Surgery

Locations

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Stanford University

Stanford, California, United States

Site Status

Northwestern Feinberg School of Medicine - Department of Orthopaedic Surgery

Chicago, Illinois, United States

Site Status

Washington University in St. Louis

St Louis, Missouri, United States

Site Status

The Ohio State Univeristy - Department of Plastic and Reconstructive Surgery

Columbus, Ohio, United States

Site Status

Medical College of Wisconsin - Hand Center

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 38600968 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31432080 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19800329 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31397919 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33794683 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34668879 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35139047 (View on PubMed)

Other Identifiers

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W81XWH1920065

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

0153-CSP-001

Identifier Type: -

Identifier Source: org_study_id