A novel miniature, wireless neurostimulator in the management of chronic craniofacial pain: Preliminary results from a prospective pilot study

Abstract

Objective: To report a novel wireless neuromodulation system for treatment of refractory craniofacial pain.

Background: Previous studies utilizing peripheral nerve stimulation (PNS) of the occipital and trigeminal nerves reported positive outcomes for alleviating neuropathic pain localized to the craniofacial and occipital areas. However several technological limitations and cosmetic concerns inhibited a more widespread acceptance and use of neuromodulation. Also, a relatively high incidence of adverse events like electrode erosions, dislocation, wire fracture and/or infection at the surgical site mandates a change in our approach to neuromodulation technology and implant techniques in the craniofacial region.

Methods: We report a novel approach for the management of craniofacial pain with a wirelessly powered, minimally invasive PNS system. The system is percutaneously implanted and placed subcutaneously adjacent to affected facial nerves via visual guidance by the clinician. In this feasibility study, pilot evidence was gathered in a cohort of ten subjects suffering from a combination of chronic headaches, facial pain for at least 15 days per month and for at least 4h/day.

Results: At four weeks post-implant follow up, all patients reported sustained pain relief of the primary pain area. Electrode location and total number of electrodes used per subject varied across the cohort. The average pain reduction using the visual analog scale was ≥82%. The procedure had no adverse events or side effects.

Conclusion: Percutaneous placement of a wireless neurostimulation device directly adjacent to affected craniofacial nerve(s) is a minimally invasive and reversible method of pain control in patients with craniofacial pain refractory to conventional medical managements. Preliminary results are encouraging and further larger scale studies are required for improved applications.

Keywords: Chronic facial pain; Cranial nerve; Neurostimulator; Peripheral nerve stimulation; Trigeminal neuralgia; Wireless implant.