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NCT Number: NCT06867185

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

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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indiana Hand to Shoulder Center, Indianapolis, Indiana, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Brief Electrical Stimulation Therapy

Device

10-minutes of electrical stimulation to repaired nerve

Other names: BES, Therapeutic Electrical Stimulation, Electrical Stimulation

Digital Nerve Repair

Procedure

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

Other names: Nerve Repair

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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. 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.

  3. 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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Director of Clincal Reseach

CONTACT

[email protected]

877-478-9106

Sponsors and collaborators

Lead sponsor

Checkpoint Surgical Inc.

Industry

Registry information

Official study title

Function And Speed of Transection Recovery After Therapeutic Electrostimulation of Nerves

Acronym: FASTR-TEN

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 10, 2025
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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