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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 24, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 25, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 10, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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