Promoting Healing of Injured Nerves With Electrical Stimulation Therapy (PHINEST)
August 26, 2026 updated by: Checkpoint Surgical Inc.
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.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
13
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43212
- The Ohio State Univeristy - Department of Plastic and Reconstructive Surgery
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Brief Electrical Stimulation Therapy
Single, 10 minute dose of electrical stimulation delivered to the injured nerve during surgical intervention.
|
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
Other Names:
|
|
No Intervention: Standard of Care
Surgical intervention for repair of peripheral nerve injury.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Motor Recovery assessed using the Medical Research Council (MRC) motor grading
Time Frame: Pre-surgery, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months
|
Grading of muscle strength on 0 to 5 scale, with higher score representing greater function.
|
Pre-surgery, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Grip Strength
Time Frame: Pre-surgery, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months
|
Maximum grip strength.
|
Pre-surgery, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months
|
|
Lateral Pinch Strength
Time Frame: Pre-surgery, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months
|
Maximum lateral pinch.
|
Pre-surgery, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months
|
|
2-point discrimination
Time Frame: Pre-surgery, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months
|
Evaluation of sensory function, measuring tactile discrimination.
|
Pre-surgery, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months
|
|
Semmes-Weinstein Monofilament Testing
Time Frame: Pre-surgery, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months
|
Evaluation of sensory function, measuring pressure detection threshold.
|
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
Time Frame: Pre-surgery, 10 days, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months
|
Questionnaire providing patient reported estimate of upper extremity function on a 0-100 scale with >50 representing greater normal function.
|
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
Time Frame: Pre-surgery, 10 days, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months
|
Questionnaire providing patient reported estimate of interference of pain on daily activities on a 0-100 scale with >50 representing greater than normal pain interference on daily activities.
|
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
Time Frame: Pre-surgery, 10 days, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months
|
Questionnaire providing patient reported estimate upper extremity function.
The score ranges from 0 (no disability) to 100 (most severe disability).
|
Pre-surgery, 10 days, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months
|
|
Electromyography (EMG)
Time Frame: 4 months, 6 months, and 8 months
|
Measurement of the electrical activity in a muscle.
|
4 months, 6 months, and 8 months
|
|
Motor Unit Number Estimation (MUNE)
Time Frame: 4 months, 6 months, and 8 months
|
Estimate of the number of motor units within the muscle based on recorded electrical activity.
|
4 months, 6 months, and 8 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Amy M Moore, MD, Ohio State University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 12, 2023
Primary Completion (Actual)
May 13, 2026
Study Completion (Actual)
May 13, 2026
Study Registration Dates
First Submitted
May 19, 2023
First Submitted That Met QC Criteria
May 30, 2023
First Posted (Actual)
June 1, 2023
Study Record Updates
Last Update Posted (Actual)
August 28, 2026
Last Update Submitted That Met QC Criteria
August 26, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0153-CSP-002
- W81XWH1920065 (Other Grant/Funding Number: Department of Defense USAMRAA)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.