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Nerve InjuryPHINESTNCT05884125

Promoting Healing of Injured Nerves With Electrical Stimulation Therapy

A study testing Checkpoint BEST System in people with Nerve Injury and Peripheral Nerve Injuries, run by Checkpoint Surgical Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Checkpoint BEST System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
1 siteUnited States
Study dates
12 Jun 2023to 13 May 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

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

    Columbus, Ohio, 43212

Other trials in United States

About this study

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.

Being tested
Checkpoint BEST System
Keywords
Therapeutic Electrical Stimulation, Brief Electrical Stimulation, Nerve Regeneration, Nerve Injury, Nerve Healing, Nerve Repair
Medical subject headings
Peripheral Nerve Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Checkpoint BEST SystemDevice

    Also called Brief Electrical Stimulation (BES) Therapy

    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

Study groups in NCT05884125
Study groupRoleWhat they receive
Brief Electrical Stimulation TherapyExperimentalSingle, 10 minute dose of electrical stimulation delivered to the injured nerve during surgical intervention.
Receives: Device: Checkpoint BEST System
Standard of CareNo interventionSurgical intervention for repair of peripheral nerve injury.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (9)

  1. Grip Strength

    Maximum grip strength.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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).

    Measured: 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.

    Measured: 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.

    Measured: 4 months, 6 months, and 8 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2023
  2. Study start12 Jun 2023
  3. Primary completion13 May 2026
  4. Study completion13 May 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05884125
Sponsor's protocol ID
0153-CSP-002
Other IDs
W81XWH1920065
Acronym
PHINEST
Status last verified
Aug 2026
First submitted
19 May 2023
Last updated
28 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

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

Questions about this trial

What is this clinical trial studying?

A study testing Checkpoint BEST System in people with Nerve Injury and Peripheral Nerve Injuries, run by Checkpoint Surgical Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05884125, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.

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