Clinical trial NCT06867185: Evaluating Therapeutic Electrical Stimulation to Improve Nerve Healing After Surgical Repair of Digital Nerve Injuries
Official title: Function And Speed of Transection Recovery After Therapeutic Electrostimulation of Nerves
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Digital Nerve Injury
Nerve Injury
Nerve Reconstruction
Nerve Trauma
Digital Nerve Lesion
Keywords: Nerve Repair
Therapeutic Electrical Stimulation
BES
Brief Electrical Stimulation
Lead sponsor: Checkpoint Surgical Inc.
Sponsor class: INDUSTRY
First posted: 2025-03-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Two Point Discrimination
timeFrame: 2 weeks - 9 months
Secondary outcomes:
measure: Semmes-Weinstein Monofilament Test
timeFrame: 2 weeks - 9 months
measure: Visual Analog Scale (VAS)
timeFrame: 2 weeks - 9 months
measure: quick Disabilities of Arm, Hand, and Shoulder (quickDASH)
timeFrame: 2 weeks - 9 months
measure: Michigan Hand Outcomes Questionnaire (MHQ)
timeFrame: 2 weeks - 9 months
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri Department of Orthopaedic Surgery
state: Missouri
city: St. Louis
country: United States
facility: Washington University in St Louis, Department of Orthopedic Surgery
state: Missouri
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.