Comparing electrical stimulation and tacrolimus (FK506) to enhance treating nerve injuries.
Sally Jo, Deng Pan, Alexandra E Halevi...
https://pubmed.ncbi.nlm.nih.gov/31397919Actively Recruiting
Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID05884125
Promoting Healing of Injured Nerves With Electrical Stimulation Therapy
Led by Checkpoint Surgical Inc. · Updated on 2024-08-21
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
C
Checkpoint Surgical Inc.
Lead Sponsor
C
Congressionally Directed Medical Research Programs
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate the use of a new electrical stimulation therapy to help heal nerve injuries in the arm after surgery. The study focuses on people with peripheral nerve injuries who are undergoing surgical repair, including nerve transfer, primary repair, or nerve grafting. Researchers want to see if a brief electrical stimulation during surgery can improve nerve healing and functional recovery compared to standard care alone. Participants will be randomly assigned to one of two groups. One group will receive the usual surgical treatment for their nerve injury, while the other group will receive the same surgery plus a single 10-minute dose of electrical stimulation to the injured nerve during the procedure. The electrical stimulation is delivered using a single-use medical device called the Checkpoint BEST System. During the study, participants will have assessments before surgery and at multiple times afterward, up to 18 months. These include tests of motor recovery, grip strength, pinch strength, sensation, pain interference, and arm function questionnaires. Electromyography and motor unit number estimation tests will also be done at several points. The research team will monitor recovery over time to understand how the electrical stimulation may affect healing and function after nerve surgery.
CONDITIONS
Brief Title
Promoting Healing of Injured Nerves With Electrical Stimulation Therapy
Who Can Participate
Age: 18Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- Upper extremity mixed or motor nerve injury from the brachial plexus to the wrist crease.
- Candidate for surgical intervention.
- Indicated for surgical repair by nerve transfer, primary repair, or nerve grafting.
- Age between 18 and 80 years.
- Signed and dated informed consent form.
You will not qualify if you...
- Severe comorbid condition, such as arrhythmia or congestive heart failure, preventing surgery.
- Primary repair requiring graft greater than 6 cm.
- Nerve reconstruction occurring more than 12 months after injury.
- Age less than 18 or greater than 80 years.
- Any contraindications to required surgical procedure, including language or mental status barriers, inability to consent, and pregnancy or lactation.
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 - Day of surgery
Participants undergo surgical intervention to repair peripheral nerve injury. During surgery, a single 10-minute dose of electrical stimulation therapy is delivered to the injured nerve for those in the experimental group.
1 visit (in-person)
Post-operative Follow-up
Duration - Up to 18 months
Participants attend follow-up visits to monitor nerve healing and functional recovery through physical assessments and patient-reported outcomes.
Visits at 10 days, 2, 4, 6, 8, 10, 12, 15, and 18 months post-surgery
Trial Site Locations
Total: 1 location
1
The Ohio State Univeristy - Department of Plastic and Reconstructive Surgery
Columbus, Ohio, United States, 43212
Actively Recruiting
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Research Team
E
Eric Walker, PhD
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/34668879Short-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/35139047Electrical stimulation enhances sensory recovery: a randomized controlled trial.
Joshua N Wong, Jaret L Olson, Michael J Morhart...
https://pubmed.ncbi.nlm.nih.gov/25727139The Effect of Electrical Stimulation on Nerve Regeneration Following Peripheral Nerve Injury.
Luke Juckett, Tiam Mana Saffari, Benjamin Ormseth...
https://pubmed.ncbi.nlm.nih.gov/36551285The Effects of Intraoperative Electrical Stimulation on Regeneration and Recovery After Nerve Isograft Repair in a Rat Model.
Grace C Keane, Deng Pan, Joseph Roh...
https://pubmed.ncbi.nlm.nih.gov/32666827