Perioperative Clinical Implementation and Usability of a Novel Nerve Stimulator to Enhance Nerve Regeneration
James R Bain, MD, MSc, Plastic Surgery, McMaster University, Hamilton, ON, Canada, Carolyn Levis, MD, MSc, Division of Plastic Surgery, McMaster University, Hamilton, ON, Canada, Katelyn JW Chan, MHSc, Epineuron Technologies Inc., Mississauga, ON, Canada, Michael P Willand, PhD, MASc, Division of Plastic and Reconstructive Surgery, Epineuron Technologies Inc., Mississauga, ON, Canada and Christopher J Coroneos, MD MSc, McMaster University, Hamilton, ON, Canada
Electrical stimulation (ES) of injured nerves enhances both motor and sensory axonal regeneration and functional outcomes. However, clinical implementation has not been standardized; current literature utilizes complicated and outdated equipment not approved for human use. The purpose of this multicenter study, was to demonstrate the implementation, safety, and usability of a novel single-use nerve stimulator in a generalizable population that delivers the therapeutic stimulation paradigm described in the literature. The secondary objective was to determine feasibility for larger a future trial.
Following informed consent, patients undergoing surgical intervention to repair or decompress peripheral nerves in the upper extremities were included in the study. A proprietary nerve stimulation system (Epineuron Technologies Inc.) with a shapeable nerve electrode was used to deliver therapeutic electrical stimulation (20Hz) for one hour perioperatively. Stimulation amplitudes utilized throughout the therapy were recorded. The primary outcome was patient tolerance to stimulation therapy immediately post-operatively. Secondary outcomes included safety, usability of the device, and patient pain levels (numeric rating scale 0-10) at the first scheduled post-operative visit, and feasibility characteristics (recruitment/retention, device/patient management).
From April to June 2021, 10 subjects (60% female, 40% male, 47.1±15 years of age) from two centers were enrolled. Procedures included carpal and cubital tunnel releases (n=7), proximal radial nerve Schwannoma excision (n=1), median nerve partial neuroma excision (n=1) and repair of both digital nerves of the thumb (n=1). Mean stimulation amplitudes during therapy were 2.7±0.97mA. All patients reported no discomfort during therapy and average numeric rating scale pain score during the first post-operative visit was 1.8±1.89 out of 10 (range 0 to 5). There were no reported adverse events. Surgeons reported that the device was easy to use, required under 5 minutes of operating room time to implement, and easily removable in the post-operative environment.
This study demonstrated the clinical application and versatility of a novel nerve stimulator in a generalizable sample of various upper extremity nerve procedures. We established that the device is safe to use, reliable, patients tolerate the therapy, and implementation of the device does not disrupt clinical workflow. Further, we have detailed recruitment/retention, personnel, trial management and technical stimulator characteristics to guide a large trial.
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