Evaluating Therapeutic Electrical Stimulation to Improve Nerve Healing After Surgical Repair of Digital Nerve Injuries (FASTR-TEN)

January 8, 2026 updated by: Checkpoint Surgical Inc.

Function And Speed of Transection Recovery After Therapeutic Electrostimulation of Nerves

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

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 Contact

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Recruiting
        • Indiana Hand to Shoulder Center
        • Contact:
        • Principal Investigator:
          • Brandon S Smetana, MD, FAAOS
        • Sub-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
    • Missouri
      • Columbia, Missouri, United States, 65212
        • Recruiting
        • University of Missouri Department of Orthopaedic Surgery
        • Contact:
        • Principal Investigator:
          • Daniel London, MD
        • Sub-Investigator:
          • Julia Nuelle, MD
        • Sub-Investigator:
          • Sebastien Lalonde, MD
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University in St Louis, Department of Orthopedic Surgery
        • Contact:
          • Clinical Reseach Coordinator
          • Phone Number: (314) 454-5967
        • Principal Investigator:
          • Christopher Dy, MD, MPH
        • Sub-Investigator:
          • David Brogan, MD, MSc
    • Ohio
      • Columbus, Ohio, United States, 43212
        • Recruiting
        • The Ohio State Univeristy - Department of Plastic and Reconstructive Surgery
        • Principal Investigator:
          • Amy M Moore, MD
        • Sub-Investigator:
          • Ryan Schmucker, MD
        • Sub-Investigator:
          • Jill Putnam, MD
        • Contact:
        • Sub-Investigator:
          • Andrew O'Brien, MD
    • Washington
      • Seattle, Washington, United States, 98104
        • Recruiting
        • Harborview Medical Center - University of Washington
        • Contact:
        • Principal Investigator:
          • Yusha Katie Liu, MD, PhD
        • Sub-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

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:

  • 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:

  • 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.

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
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
Standard of care surgical repair of digital nerve injury as determined by health care provider.
Other Names:
  • 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.
Procedure: Digital Nerve Repair
Standard of care surgical repair of digital nerve injury as determined by health care provider.
Other Names:
  • Nerve Repair
Device: Brief Electrical Stimulation Therapy
10-minutes of electrical stimulation to repaired nerve
Other Names:
  • Electrical Stimulation
  • BES
  • Therapeutic Electrical Stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Two Point Discrimination
Time Frame: 2 weeks - 9 months
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.
2 weeks - 9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Semmes-Weinstein Monofilament Test
Time Frame: 2 weeks - 9 months
Evaluation of sensory function, measuring pressure detection threshold. Evaluated at each follow-up visit.
2 weeks - 9 months
Visual Analog Scale (VAS)
Time Frame: 2 weeks - 9 months
Self reported rating of pain marked on a 100mm visual analog scale. Evaluated at each follow-up visit.
2 weeks - 9 months
quick Disabilities of Arm, Hand, and Shoulder (quickDASH)
Time Frame: 2 weeks - 9 months
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.
2 weeks - 9 months
Michigan Hand Outcomes Questionnaire (MHQ)
Time Frame: 2 weeks - 9 months
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.
2 weeks - 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Checkpoint Surgical Inc.

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

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)

April 24, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

February 25, 2025

First Submitted That Met QC Criteria

March 4, 2025

First Posted (Actual)

March 10, 2025

Study Record Updates

Last Update Posted (Actual)

January 9, 2026

Last Update Submitted That Met QC Criteria

January 8, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0153-CSP-300

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

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.

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