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RecruitingNCT06867185FASTR-TENUpdated Jan 9, 2026

Evaluating Therapeutic Electrical Stimulation to Improve Nerve Healing After Surgical Repair of Digital Nerve Injuries

An interventional study of Brief Electrical Stimulation Therapy and Digital Nerve Repair in Digital Nerve Injury, Nerve Injury and Nerve Reconstruction, sponsored by Checkpoint Surgical Inc.. Recruiting at 5 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-01-09.

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

From the registry’s dates

  • Started Apr 2025; still recruiting 1 year 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

The goal of this clinical study is to evaluate if a period of electrical stimulation delivered during the surgical repair procedure can speed up nerve healing.

02

Conditions studied

  • Digital Nerve Injury
  • Nerve Injury
  • Nerve Reconstruction
  • Nerve Trauma
  • Digital Nerve Lesion

Keywords

  • Nerve Repair
  • Therapeutic Electrical Stimulation
  • BES
  • Brief Electrical Stimulation
03

In context

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

  • Age 18-80 years
  • Candidate for surgical intervention under general anesthesia.
  • Require primary nerve injury repair in at least 1 digital nerve.
  • Following resection, have a resulting nerve gap of ≤ 10mm.
  • Able to complete tension-free end-to-end direct repair, or repair with a conduit, autograft, or allograft with a length ≤15mm
  • Signed and dated informed consent form.

Exclusion criteria

Exclusion Criteria:

  • Severe comorbid conditions, such as arrhythmia or congestive heart failure, preventing surgery under general anesthesia.
  • Nerve repair occurring >1 month post-injury.
  • Incomplete nerve transection.
  • Injury requiring replantation of target digit
  • Injury distal to the distal interphalangeal joint.
  • Injury proximal to branching into the proper or common digital nerves.
  • Injuries to both digital arteries of an affected digit.
  • History of neuropathy, diabetic neuropathy, or any other known neuropathy
  • History of chronic ischemic condition of the upper extremity
  • Cognitive impairment preventing the ability to provide consent, follow post-operative instructions, or complete clinical assessments.
05

Study design

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

Study arms

  • Active comparator
    Standard of Care Repair

    Individuals will receive standard of care surgical repair of their digital nerve injury as determined by their surgeon.

    Procedure: Digital Nerve Repair

  • Experimental
    Repair + Therapy

    During the surgical repair for digital nerve injury (standard of care), a 10 minute dose of therapeutic electrical stimulation will be delivered during surgery.

    Device: Brief Electrical Stimulation Therapy · Procedure: Digital Nerve Repair

Interventions

  • DeviceBrief Electrical Stimulation Therapy

    10-minutes of electrical stimulation to repaired nerve

    Also known as: BES, Therapeutic Electrical Stimulation, Electrical Stimulation

  • ProcedureDigital Nerve Repair

    Standard of care surgical repair of digital nerve injury as determined by health care provider.

    Also known as: Nerve Repair

06

What researchers measure

Primary outcomes

  1. Two Point Discrimination

    Evaluation of sensory function based on ability to discern two point of contact for different distances between the contacts (2-15mm). Evaluated at each follow-up visit.

    Time frame: 2 weeks - 9 months

Secondary outcomes

  1. Semmes-Weinstein Monofilament Test

    Evaluation of sensory function, measuring pressure detection threshold. Evaluated at each follow-up visit.

    Time frame: 2 weeks - 9 months

  2. Visual Analog Scale (VAS)

    Self reported rating of pain marked on a 100mm visual analog scale. Evaluated at each follow-up visit.

    Time frame: 2 weeks - 9 months

  3. quick Disabilities of Arm, Hand, and Shoulder (quickDASH)

    Questionnaire providing patient reported estimate upper extremity function following injuries or disorders to the arm, hand, or shoulder. Responses to 11 questions answered on a 1-5 scale are used to calculate a scorescore ranging from 0 (no disability) to 100 (most severe disability). Evaluated at each follow-up visit.

    Time frame: 2 weeks - 9 months

  4. Michigan Hand Outcomes Questionnaire (MHQ)

    A patient reported questionnaire consisting of 37 questions answered on a 1-5 scale used to calculate an estimate of hand function on a 0-100 scale with a higher number indication greater hand function. Evaluated at each follow-up visit.

    Time frame: 2 weeks - 9 months

07

Study locations

5 of 5 sites recruiting
  • Indiana Hand to Shoulder Center
    Indianapolis, Indiana 46260, United States
    • Melanie Glover · Contact · mglover@orthoindy.com
    • Brandon S Smetana, MD, FAAOS · Principal investigator
    • Ian Chow, MD · Sub investigator
    • Nicholas E Crosby, MD · Sub investigator
    • Jeffrey A Greenberg, MD, MS · Sub investigator
    • F. Thomas D Kaplan, MD, FAAOS · Sub investigator
    • Gregory A Merrell, MD · Sub investigator
    • Kathryn M Peck, MD · Sub investigator
    • Sameer K Puri, MD · Sub investigator
    Recruiting
  • University of Missouri Department of Orthopaedic Surgery
    Columbia, Missouri 65212, United States
    • Research Coordinator · Contact · UMHSorthoenroll@health.missouri.edu
    • Daniel London, MD · Principal investigator
    • Julia Nuelle, MD · Sub investigator
    • Sebastien Lalonde, MD · Sub investigator
    Recruiting
  • Washington University in St Louis, Department of Orthopedic Surgery
    St Louis, Missouri 63110, United States
    • Clinical Reseach Coordinator · Contact · (314) 454-5967
    • Christopher Dy, MD, MPH · Principal investigator
    • David Brogan, MD, MSc · Sub investigator
    Recruiting
  • The Ohio State Univeristy - Department of Plastic and Reconstructive Surgery
    Columbus, Ohio 43212, United States
    • Research Coordinator · Contact · nervenerds@osumc.edu · (614)-293-8566
    • Amy M Moore, MD · Principal investigator
    • Andrew O'Brien, MD · Sub investigator
    • Jill Putnam, MD · Sub investigator
    • Ryan Schmucker, MD · Sub investigator
    Recruiting
  • Harborview Medical Center - University of Washington
    Seattle, Washington 98104, United States
    • Research Coordinator · Contact · traumaresearch@uw.edu
    • Yusha Katie Liu, MD, PhD · Principal investigator
    • Chelsea Boe, MD · Sub investigator
    • Christopher Crowe, MD · Sub investigator
    • Jeffrey Friedrich, MD, MC, FACS · Sub investigator
    • Stephen Kennedy, MD, FRCSC · Sub investigator
    • Erin Miller, MD, MS · Sub investigator
    Recruiting
08

References and documents

Publications

  • 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 ↗
  • 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 ↗
  • Saffari TM, Walker ER, Pet MA, Moore AM. Brief Intraoperative Electrical Stimulation to Enhance Nerve Regeneration. Plast Reconstr Surg Glob Open. 2024 Apr 10;12(4):e5730. doi: 10.1097/GOX.0000000000005730. eCollection 2024 Apr. No abstract available. PubMed 38600968 ↗
  • 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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06867185
Lead sponsor
Checkpoint Surgical Inc.
Responsible party
Sponsor
First posted
Mar 10, 2025
Start date
Apr 24, 2025
Primary completion
Jan 2027 (estimated)
Completion
Mar 2027 (estimated)
Last update
Jan 9, 2026

Study contacts

Director of Clincal Reseach
Contact
clinical@checkpointsurgical.com
877-478-9106

Oversight

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

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