Promoting Healing of Injured Nerves With Electrical Stimulation Therapy

Обзор

This study is evaluating a new therapeutic use of electrical stimulation to promote nerve healing and improve functional recovery following surgical intervention for peripheral nerve injury in arm. Participants will be randomized into one of two groups, treatment or control, with all participants receiving standard of care treatment for the nerve injury. The treatment group will also receive a single dose of the therapeutic stimulation during the surgical intervention for their nerve injury.

Подробное описание

Preliminary research has shown that delivering a brief period of electrical stimulation following nerve repair promotes nerve healing and functional recovery. This pilot 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 peripheral nerve injury in the arm.

Вмешательства

• Устройство 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

Первичные конечные точки

• Change in Motor Recovery assessed using the Medical Research Council (MRC) motor grading [Срок оценки: Pre-surgery, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months]

Вторичные конечные точки (9)

• Grip Strength [Срок оценки: Pre-surgery, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months]
• Lateral Pinch Strength [Срок оценки: Pre-surgery, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months]
• 2-point discrimination [Срок оценки: Pre-surgery, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months]
• Semmes-Weinstein Monofilament Testing [Срок оценки: Pre-surgery, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months]
• Patient Reported Outcome Measurement System (PROMIS) Upper Extremity Function [Срок оценки: Pre-surgery, 10 days, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months]
• Patient Reported Outcome Measurement System (PROMIS) Pain Interference [Срок оценки: Pre-surgery, 10 days, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months]
• quick Disabilities of thee Arm, Shoulder, and Hand (DASH) questionnaire [Срок оценки: Pre-surgery, 10 days, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months]
• Electromyography (EMG) [Срок оценки: 4 months, 6 months, and 8 months]
• Motor Unit Number Estimation (MUNE) [Срок оценки: 4 months, 6 months, and 8 months]

Критерии участия

Критерии включения

• Upper extremity mixed or motor nerve injury from the brachial plexus to the wrist crease.
• Candidate for surgical intervention.
• Indicated for surgical repair by nerve transfer, primary repair, or nerve grafting.
• Are age 18-80 years.
• Signed and dated informed consent form.

Критерии исключения

• Severe comorbid condition, such as arrhythmia or congestive heart failure, preventing surgery.
• Primary repair requiring graft >6cm.
• Nerve reconstruction occurring >12 months post injury.
• Age less than 18 or greater than 80 years.
• All contraindications to included/required surgical procedure, including but not limited to language barriers, mental status barriers, inability to consent, and pregnancy/lactation.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• The Ohio State Univeristy - Department of Plastic and Reconstructive Surgery — Columbus

Публикации

• 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
• 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
• 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
• 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. PMID 25727139
• Juckett L, Saffari TM, Ormseth B, Senger JL, Moore AM. The Effect of Electrical Stimulation on Nerve Regeneration Following Peripheral Nerve Injury. Biomolecules. 2022 Dec 12;12(12):1856. doi: 10.3390/biom12121856. PMID 36551285
• Keane GC, Pan D, Roh J, Larson EL, Schellhardt L, Hunter DA, Snyder-Warwick AK, Moore AM, Mackinnon SE, Wood MD. The Effects of Intraoperative Electrical Stimulation on Regeneration and Recovery After Nerve Isograft Repair in a Rat Model. Hand (N Y). 2022 May;17(3):540-548. doi: 10.1177/1558944720939200. Epub 2020 Jul 15. PMID 32666827

Идентификаторы

NCT: NCT05884125 · 0153-CSP-002 · W81XWH1920065

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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