Evaluating Therapeutic Electrical Stimulation to Improve Nerve Healing After Surgical Repair of Digital Nerve Injuries

NCT ID: NCT06867185

Last Updated: 2026-01-09

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

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-24

Study Completion Date

2027-03-31

Brief Summary

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The goal of this clinical study is to evaluate if a period of electrical stimulation delivered during the surgical repair procedure can speed up nerve healing.

Detailed Description

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Conditions

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Digital Nerve Injury Nerve Injury Nerve Reconstruction Nerve Trauma Digital Nerve Lesion

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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Standard of Care Repair

Individuals will receive standard of care surgical repair of their digital nerve injury as determined by their surgeon.

Group Type ACTIVE_COMPARATOR

Digital Nerve Repair

Intervention Type PROCEDURE

Standard of care surgical repair of digital nerve injury as determined by health care provider.

Repair + Therapy

During the surgical repair for digital nerve injury (standard of care), a 10 minute dose of therapeutic electrical stimulation will be delivered during surgery.

Group Type EXPERIMENTAL

Brief Electrical Stimulation Therapy

Intervention Type DEVICE

10-minutes of electrical stimulation to repaired nerve

Digital Nerve Repair

Intervention Type PROCEDURE

Standard of care surgical repair of digital nerve injury as determined by health care provider.

Interventions

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Brief Electrical Stimulation Therapy

10-minutes of electrical stimulation to repaired nerve

Intervention Type DEVICE

Digital Nerve Repair

Standard of care surgical repair of digital nerve injury as determined by health care provider.

Intervention Type PROCEDURE

Other Intervention Names

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BES Therapeutic Electrical Stimulation Electrical Stimulation Nerve Repair

Eligibility Criteria

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Inclusion Criteria

* Age 18-80 years
* Candidate for surgical intervention under general anesthesia.
* Require primary nerve injury repair in at least 1 digital nerve.
* Following resection, have a resulting nerve gap of ≤ 10mm.
* Able to complete tension-free end-to-end direct repair, or repair with a conduit, autograft, or allograft with a length ≤15mm
* Signed and dated informed consent form.

Exclusion Criteria

* Severe comorbid conditions, such as arrhythmia or congestive heart failure, preventing surgery under general anesthesia.
* Nerve repair occurring \>1 month post-injury.
* Incomplete nerve transection.
* Injury requiring replantation of target digit
* Injury distal to the distal interphalangeal joint.
* Injury proximal to branching into the proper or common digital nerves.
* Injuries to both digital arteries of an affected digit.
* History of neuropathy, diabetic neuropathy, or any other known neuropathy
* History of chronic ischemic condition of the upper extremity
* Cognitive impairment preventing the ability to provide consent, follow post-operative instructions, or complete clinical assessments.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Checkpoint Surgical Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Indiana Hand to Shoulder Center

Indianapolis, Indiana, United States

Site Status RECRUITING

University of Missouri Department of Orthopaedic Surgery

Columbia, Missouri, United States

Site Status RECRUITING

Washington University in St Louis, Department of Orthopedic Surgery

St Louis, Missouri, United States

Site Status RECRUITING

The Ohio State Univeristy - Department of Plastic and Reconstructive Surgery

Columbus, Ohio, United States

Site Status RECRUITING

Harborview Medical Center - University of Washington

Seattle, Washington, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Director of Clincal Reseach

Role: CONTACT

877-478-9106

Facility Contacts

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Melanie Glover

Role: primary

Research Coordinator

Role: primary

Clinical Reseach Coordinator

Role: primary

(314) 454-5967

Research Coordinator

Role: primary

(614)-293-8566

Research Coordinator

Role: primary

References

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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)

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)

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)

Wong JN, Olson JL, Morhart MJ, Chan KM. Electrical stimulation enhances sensory recovery: a randomized controlled trial. Ann Neurol. 2015 Jun;77(6):996-1006. doi: 10.1002/ana.24397. Epub 2015 May 4.

Reference Type BACKGROUND
PMID: 25727139 (View on PubMed)

Other Identifiers

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0153-CSP-300

Identifier Type: -

Identifier Source: org_study_id

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