Recruiting

Therapeutic Electrical Stimulation

Sponsor:

Checkpoint Surgical Inc.

Code:

NCT06867185

Conditions

Digital Nerve Injury

Nerve Injury

Nerve Reconstruction

Nerve Trauma

Digital Nerve Lesion

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Brief Electrical Stimulation Therapy

Digital Nerve Repair

Study Details

Brief 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.

Conditions

Digital Nerve Injury

Nerve Injury

Nerve Reconstruction

Nerve Trauma

Digital Nerve Lesion

Study ID

NCT06867185

Start date

Apr 24, 2025

Status verified date

Jan, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

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.

Interventions

Brief Electrical Stimulation Therapy

10-minutes of electrical stimulation to repaired nerve

Digital Nerve Repair

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

Primary outcome measure

  • Two Point Discrimination [ Time Frame: 2 weeks - 9 months ]

Central Contacts and Locations

Central contacts

Director of Clincal Reseach

877-478-9106clinical@checkpointsurgical.com

Locations

Indiana Hand to Shoulder Center

Recruiting

Indianapolis, Indiana, United States, 46260

Contacts

Melanie Glover

mglover@orthoindy.com

Principal Investigator:

Brandon S Smetana, MD, FAAOS

University of Missouri Department of Orthopaedic Surgery

Recruiting

Columbia, Missouri, United States, 65212

Contacts

Research Coordinator

UMHSorthoenroll@health.missouri.edu

Principal Investigator:

Daniel London, MD

Washington University in St Louis, Department of Orthopedic Surgery

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Clinical Reseach Coordinator

(314) 454-5967

Principal Investigator:

Christopher Dy, MD, MPH

The Ohio State Univeristy - Department of Plastic and Reconstructive Surgery

Recruiting

Columbus, Ohio, United States, 43212

Contacts

Research Coordinator

(614)-293-8566nervenerds@osumc.edu

Principal Investigator:

Amy M Moore, MD

Harborview Medical Center - University of Washington

Recruiting

Seattle, Washington, United States, 98104

Contacts

Research Coordinator

traumaresearch@uw.edu

Principal Investigator:

Yusha Katie Liu, MD, PhD

More Information

Sponsor

Checkpoint Surgical Inc.

Last update posted

Jan 9, 2026

Last verified

Jan, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Checkpoint Surgical Inc. on 2026-01-09.