Using electrical stimulation to enhance nerve healing after surgery for digital nerve injuries

Function And Speed of Transection Recovery After Therapeutic Electrostimulation of Nerves

This study tests if using electrical stimulation during surgery can help people with finger nerve injuries heal faster and better.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Checkpoint Surgical Inc. (industry)
• Locations: 5 sites (Indianapolis, Indiana and 4 other locations)
• Trial ID: NCT06867185 on ClinicalTrials.gov

What this trial studies

This clinical study aims to evaluate the effectiveness of brief electrical stimulation delivered during surgical repair of digital nerve injuries to accelerate nerve healing. Participants will undergo surgical intervention for primary nerve injury repair, and the study will assess whether the addition of electrical stimulation can improve recovery outcomes. The study focuses on patients with specific criteria, including a nerve gap of 10mm or less, and will monitor healing progress post-surgery.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-80 who require surgical repair of a digital nerve injury with a nerve gap of 10mm or less.

Not a fit: Patients with severe comorbid conditions, incomplete nerve transection, or those requiring replantation of the target digit may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly enhance recovery times and functional outcomes for patients with digital nerve injuries.

How similar studies have performed: While the use of electrical stimulation in nerve repair is a promising area, this specific approach is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

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.

Where this trial is running

Indianapolis, Indiana and 4 other locations

• Indiana Hand to Shoulder Center — Indianapolis, Indiana, United States (RECRUITING)
• University of Missouri Department of Orthopaedic Surgery — Columbia, Missouri, United States (RECRUITING)
• Washington University in St Louis, Department of Orthopedic Surgery — St Louis, Missouri, United States (RECRUITING)
• The Ohio State Univeristy - Department of Plastic and Reconstructive Surgery — Columbus, Ohio, United States (RECRUITING)
• Harborview Medical Center - University of Washington — Seattle, Washington, United States (RECRUITING)

Study contacts

• Study coordinator: Director of Clincal Reseach

Conditions: Digital Nerve Injury, Nerve Injury, Nerve Reconstruction, Nerve Trauma, Digital Nerve Lesion, Nerve Repair, Therapeutic Electrical Stimulation, BES