NCT05884125

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
13mo left

Started Jun 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress73%
Jun 2023Jun 2027

First Submitted

Initial submission to the registry

May 19, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 1, 2023

Completed
11 days until next milestone

Study Start

First participant enrolled

June 12, 2023

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

August 21, 2024

Status Verified

August 1, 2024

Enrollment Period

4 years

First QC Date

May 19, 2023

Last Update Submit

August 20, 2024

Conditions

Nerve InjuryPeripheral Nerve InjuriesPeripheral Nerve Injury Upper LimbNerve Palsy

Keywords

Therapeutic Electrical StimulationBrief Electrical StimulationNerve RegenerationNerve InjuryNerve HealingNerve Repair

Outcome Measures

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.

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

Secondary Outcomes (9)

  • Grip Strength

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

  • Lateral Pinch Strength

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

  • 2-point discrimination

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

  • Semmes-Weinstein Monofilament Testing

    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

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

  • +4 more secondary outcomes

Study Arms (2)

Brief Electrical Stimulation Therapy

EXPERIMENTAL

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

Device: Checkpoint BEST System

Standard of Care

NO INTERVENTION

Surgical intervention for repair of peripheral nerve injury.

Interventions

Checkpoint BEST SystemDEVICE

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
Brief Electrical Stimulation Therapy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State Univeristy - Department of Plastic and Reconstructive Surgery

Columbus, Ohio, 43212, United States

RECRUITING

Related Publications (6)

  • 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: 31397919BACKGROUND

  • 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: 34668879BACKGROUND

  • 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: 35139047BACKGROUND

  • 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: 25727139BACKGROUND

  • 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: 36551285BACKGROUND

  • 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: 32666827BACKGROUND

MeSH Terms

Conditions

Peripheral Nerve Injuries

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Amy M Moore, MD

    Ohio State University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric Walker, PhD

CONTACT

216-370-9107ewalker@checkpointsurgical.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2023

First Posted

June 1, 2023

Study Start

June 12, 2023

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

August 21, 2024

Record last verified: 2024-08

Locations

US(1)