CClinicalTrials.gg
CompletedNCT05884125PHINESTUpdated Aug 28, 2026

Promoting Healing of Injured Nerves With Electrical Stimulation Therapy

An interventional study of Checkpoint BEST System in Nerve Injury, Peripheral Nerve Injuries and Peripheral Nerve Injury Upper Limb, sponsored by Checkpoint Surgical Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-28.

Sponsored by Checkpoint Surgical Inc. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
13
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • 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
03

In context

Peripheral Nerve Injuries

87 studies on the registry are indexed under Peripheral Nerve Injuries; 20 are open to participants now.

This study's enrollment of 13 is below the median of 44 across 58 interventional studies indexed under Peripheral Nerve Injuries.

Browse Peripheral Nerve Injuries studies →

Lead sponsor

Checkpoint Surgical Inc. is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
13 participants (actual)

Study arms

  • Experimental
    Brief Electrical Stimulation Therapy

    Single, 10 minute dose of electrical stimulation delivered to the injured nerve during surgical intervention.

    Device: Checkpoint BEST System

  • No intervention
    Standard of Care

    Surgical intervention for repair of peripheral nerve injury.

Interventions

  • DeviceCheckpoint 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

    Also known as: Brief Electrical Stimulation (BES) Therapy

06

What researchers measure

Primary outcomes

  1. Change in Motor Recovery assessed using the Medical Research Council (MRC) motor grading

    Grading of muscle strength on 0 to 5 scale, with higher score representing greater function.

    Time frame: Pre-surgery, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months

Secondary outcomes

  1. Grip Strength

    Maximum grip strength.

    Time frame: Pre-surgery, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months

  2. Lateral Pinch Strength

    Maximum lateral pinch.

    Time frame: Pre-surgery, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months

  3. 2-point discrimination

    Evaluation of sensory function, measuring tactile discrimination.

    Time frame: Pre-surgery, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months

  4. Semmes-Weinstein Monofilament Testing

    Evaluation of sensory function, measuring pressure detection threshold.

    Time frame: Pre-surgery, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months

  5. Patient Reported Outcome Measurement System (PROMIS) Upper Extremity Function

    Questionnaire providing patient reported estimate of upper extremity function on a 0-100 scale with \>50 representing greater normal function.

    Time frame: Pre-surgery, 10 days, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months

  6. Patient Reported Outcome Measurement System (PROMIS) Pain Interference

    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.

    Time frame: Pre-surgery, 10 days, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months

  7. quick Disabilities of thee Arm, Shoulder, and Hand (DASH) questionnaire

    Questionnaire providing patient reported estimate upper extremity function. The score ranges from 0 (no disability) to 100 (most severe disability).

    Time frame: Pre-surgery, 10 days, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months

  8. Electromyography (EMG)

    Measurement of the electrical activity in a muscle.

    Time frame: 4 months, 6 months, and 8 months

  9. Motor Unit Number Estimation (MUNE)

    Estimate of the number of motor units within the muscle based on recorded electrical activity.

    Time frame: 4 months, 6 months, and 8 months

07

Study locations

1 site
  • The Ohio State Univeristy - Department of Plastic and Reconstructive Surgery
    Columbus, Ohio 43212, United States
08

References and documents

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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 32666827 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05884125
Lead sponsor
Checkpoint Surgical Inc.
Collaborators
Congressionally Directed Medical Research Programs
Responsible party
Sponsor
First posted
Jun 1, 2023
Start date
Jun 12, 2023
Primary completion
May 13, 2026
Completion
May 13, 2026
Last update
Aug 28, 2026

Study contacts

Amy M Moore, MD
principal investigator · Ohio State University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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