Clinical trial NCT05884125: Promoting Healing of Injured Nerves With Electrical Stimulation Therapy
Official title: Promoting Healing of Injured Nerves With Electrical Stimulation Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nerve Injury
Peripheral Nerve Injuries
Peripheral Nerve Injury Upper Limb
Nerve Palsy
Keywords: Therapeutic Electrical Stimulation
Brief Electrical Stimulation
Nerve Regeneration
Nerve Injury
Nerve Healing
Nerve Repair
Lead sponsor: Checkpoint Surgical Inc.
Sponsor class: INDUSTRY
Collaborators: name: Congressionally Directed Medical Research Programs
First posted: 2023-06-01
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: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in Motor Recovery assessed using the Medical Research Council (MRC) motor grading
timeFrame: Pre-surgery, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months
Secondary outcomes:
measure: Grip Strength
timeFrame: Pre-surgery, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months
measure: Lateral Pinch Strength
timeFrame: Pre-surgery, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months
measure: 2-point discrimination
timeFrame: Pre-surgery, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months
measure: Semmes-Weinstein Monofilament Testing
timeFrame: Pre-surgery, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months
measure: Patient Reported Outcome Measurement System (PROMIS) Upper Extremity Function
timeFrame: Pre-surgery, 10 days, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months
measure: Patient Reported Outcome Measurement System (PROMIS) Pain Interference
timeFrame: Pre-surgery, 10 days, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months
measure: quick Disabilities of thee Arm, Shoulder, and Hand (DASH) questionnaire
timeFrame: Pre-surgery, 10 days, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months
measure: Electromyography (EMG)
timeFrame: 4 months, 6 months, and 8 months
measure: Motor Unit Number Estimation (MUNE)
timeFrame: 4 months, 6 months, and 8 months
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State Univeristy - Department of Plastic and Reconstructive Surgery
state: Ohio
Study officials:
affiliation: Ohio State University
name: Amy M Moore, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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: 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: 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.
citation: 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.
citation: 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.