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/35139047/Actively Recruiting
Led by Checkpoint Surgical Inc. · Updated on 2026-01-09
60
Participants Needed
5
Research Sites
8 weeks
Total Duration
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
Evaluating Therapeutic Electrical Stimulation to Improve Nerve Healing After Surgical Repair of Digital Nerve Injuries
D
Director of Clincal Reseach
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Checkpoint Surgical Inc.
Lead 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 | Nerve Repair with 10-Minute Electrical Stimulation | Standard Digital Nerve Repair Alone |
|---|---|---|
| What it is | Standard microsurgical digital nerve repair with an added 10-minute session of brief electrical stimulation delivered immediately after the repair during the surgical procedure. | Standard of care digital nerve repair using direct suture, conduit, autograft, or allograft as appropriate, without additional electrical stimulation. |
| Role in the trial | Investigational arm testing whether a brief electrical stimulation immediately following repair improves nerve healing and sensory recovery. | Active control arm representing the current standard surgical approach for digital nerve injuries. |
| Primary use | Evaluated as an adjunct to standard repair to speed recovery and improve sensory function following digital nerve reconstruction. | Re-establishes nerve continuity, aiming to restore sensation in the affected digit after injury. |
| How it is given or performed | After primary nerve repair is completed during surgery, a device delivers electrical stimulation to the repaired nerve for 10 minutes, following specific protocols for stimulation parameters. | Microsurgical nerve repair is performed according to routine clinical practice under general anesthesia, with no added electrical stimulation. |
| Evidence status | Preliminary studies show improved axon regeneration and sensory recovery in animal models. A published randomized trial indicates that short-duration perioperative electrical stimulation may enhance sensory outcomes in mixed human upper limb nerve injury, but evidence is limited and not specific to digital nerves. | Standard surgical repair restores nerve integrity and enables varying degrees of functional recovery, but incomplete or delayed sensory return remains common, especially for longer nerve gaps or complex injuries. |
| Important limitations | Limited published evidence in humans with digital nerve injury; most supporting data come from animal models or heterogeneous patient populations. The optimal stimulation parameters and patient selection are not yet fully established. | Recovery of sensation after digital nerve repair is often incomplete, and some patients experience persistent numbness or sensory deficits even after successful surgical repair. |
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.
You may qualify if you...
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Lead Sponsor