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
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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RECRUITING
NA
60 participants
INTERVENTIONAL
2025-04-24
2027-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
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.
Digital Nerve Repair
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.
Brief Electrical Stimulation Therapy
10-minutes of electrical stimulation to repaired nerve
Digital Nerve Repair
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
Digital Nerve Repair
Standard of care surgical repair of digital nerve injury as determined by health care provider.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Checkpoint Surgical Inc.
INDUSTRY
Responsible Party
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Locations
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Indiana Hand to Shoulder Center
Indianapolis, Indiana, United States
University of Missouri Department of Orthopaedic Surgery
Columbia, Missouri, United States
Washington University in St Louis, Department of Orthopedic Surgery
St Louis, Missouri, United States
The Ohio State Univeristy - Department of Plastic and Reconstructive Surgery
Columbus, Ohio, United States
Harborview Medical Center - University of Washington
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Clinical Reseach 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.
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.
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.
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.
Other Identifiers
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0153-CSP-300
Identifier Type: -
Identifier Source: org_study_id
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