Short-Duration, Pulsatile, Electrical Stimulation Therapy Accelerates Axon Regeneration and Recovery following Tibial Nerve Injury and Repair in Rats.
Joseph Roh, Lauren Schellhardt, Grace C Keane...
https://pubmed.ncbi.nlm.nih.gov/35139047Actively Recruiting
Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID06867185
Function And Speed of Transection Recovery After Therapeutic Electrostimulation of Nerves
Led by Checkpoint Surgical Inc. · Updated on 2026-01-09
60
Participants Needed
5
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether delivering a short period of electrical stimulation during surgical repair can speed up nerve healing in people with digital nerve injuries. The study focuses on patients requiring surgical intervention to repair nerve damage in their fingers and aims to assess the recovery of nerve function after treatment. Participants will receive standard surgical repair of their digital nerve injury as determined by their surgeon. During the surgery, one group will receive an additional 10-minute dose of therapeutic electrical stimulation to the repaired nerve. The study compares outcomes between those who receive standard care alone and those who receive the extra electrical stimulation during surgery. Throughout the study, participants will be assessed over a period from 2 weeks up to 9 months after surgery. Researchers will use tests such as Two Point Discrimination, Semmes-Weinstein Monofilament Test, Visual Analog Scale (VAS), quick Disabilities of Arm, Hand, and Shoulder (quickDASH), and the Michigan Hand Outcomes Questionnaire (MHQ) to measure nerve function, sensation, pain, and hand disability. Participants will be monitored closely to evaluate the speed and quality of nerve recovery.
CONDITIONS
Brief Title
Evaluating Therapeutic Electrical Stimulation to Improve Nerve Healing After Surgical Repair of Digital Nerve Injuries
Who Can Participate
Age: 18Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- 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 64 10mm
- Able to complete tension-free end-to-end direct repair, or repair with a conduit, autograft, or allograft with a length 64 15mm
- Signed and dated informed consent form
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - 1 day
Participants undergo surgical repair of the digital nerve injury. During surgery, some participants receive a 10-minute dose of therapeutic electrical stimulation to the repaired nerve.
1 surgical visit
Post-operative Follow-up
Duration - 2 weeks to 9 months
Participants are monitored and assessed for nerve healing and functional recovery following surgery.
Regular follow-up visits for assessments over 9 months
Trial Site Locations
Total: 5 locations
1
Indiana Hand to Shoulder Center
Indianapolis, Indiana, United States, 46260
Actively Recruiting
2
University of Missouri Department of Orthopaedic Surgery
Columbia, Missouri, United States, 65212
Actively Recruiting
3
Washington University in St Louis, Department of Orthopedic Surgery
St Louis, Missouri, United States, 63110
Actively Recruiting
4
The Ohio State Univeristy - Department of Plastic and Reconstructive Surgery
Columbus, Ohio, United States, 43212
Actively Recruiting
5
Harborview Medical Center - University of Washington
Seattle, Washington, United States, 98104
Actively Recruiting
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Research Team
D
Director of Clincal Reseach
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Brief Electrical Stimulation Accelerates Axon Regeneration and Promotes Recovery Following Nerve Transection and Repair in Mice.
Junichi Sayanagi, Jesús A Acevedo-Cintrón, Deng Pan...
https://pubmed.ncbi.nlm.nih.gov/34668879Brief Intraoperative Electrical Stimulation to Enhance Nerve Regeneration.
Tiam M Saffari, Eric R Walker, Mitchell A Pet...
https://pubmed.ncbi.nlm.nih.gov/38600968Electrical stimulation enhances sensory recovery: a randomized controlled trial.
Joshua N Wong, Jaret L Olson, Michael J Morhart...
https://pubmed.ncbi.nlm.nih.gov/25727139