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/34668879/Actively Recruiting
Led by Checkpoint Surgical Inc. · Updated on 2024-08-21
60
Participants Needed
1
Research Sites
N/A
Total Duration
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
Promoting Healing of Injured Nerves With Electrical Stimulation Therapy
E
Eric Walker, PhD
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Checkpoint Surgical Inc.
Lead Sponsor
Congressionally Directed Medical Research Programs
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Brief Electrical Stimulation | Standard of Care |
|---|---|---|
| What it is | A single-use medical device system delivering a 10-minute dose of brief electrical stimulation directly to the injured nerve during surgical repair. | Surgical nerve repair performed according to current clinical standards, without additional electrical stimulation. |
| Role in trial | Investigational arm testing whether intraoperative electrical stimulation improves nerve healing after surgery. | Comparison arm representing standard surgical treatment without device intervention. |
| Primary use | Intended to accelerate nerve regeneration and potentially enhance motor and sensory recovery when added to surgical nerve repair. | Aims to restore nerve continuity and function through established surgical techniques, without adjunct stimulation. |
| How it is given or performed | During surgery, the device delivers brief stimulation directly to the repaired nerve for one 10-minute session using an intraoperative lead. | Surgical repair performed following routine microsurgical techniques; no device applied and no stimulation delivered. |
| Evidence status | Preclinical and early clinical studies support accelerated nerve regeneration and improved outcomes with brief electrical stimulation after nerve injury, but high-quality evidence in humans remains limited and larger trials are needed for confirmation. | Established by long-term clinical use as the current surgical approach for restoring nerve continuity and function after injury, but may offer only partial and sometimes slow functional recovery. |
| Important limitations | Potential benefits in humans require further validation in larger and broader patient populations; optimal timing and patient selection are not fully established. | Standard surgery can be limited by delayed or incomplete nerve regeneration and functional recovery; outcomes may depend on injury severity, timing, and individual healing. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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)
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
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/35139047/Checkpoint Surgical Inc.
Lead Sponsor
Congressionally Directed Medical Research Programs
Collaborating Sponsor