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Scandinavian Journal of Pain

Official Journal of the Scandinavian Association for the Study of Pain

Editor-in-Chief: Breivik, Harald


CiteScore 2017: 0.84

SCImago Journal Rank (SJR) 2017: 0.401
Source Normalized Impact per Paper (SNIP) 2017: 0.452

Online
ISSN
1877-8879
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Volume 17, Issue 1

Issues

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

Richard L. Weiner
  • Dallas Neurosurgical and Spine Associates, University of Texas Southwestern Medical School, Dallas, TX, USA
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Carlos Montes Garcia / Niek Vanquathem
Published Online: 2017-10-01 | DOI: https://doi.org/10.1016/j.sjpain.2017.09.010

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 4 h/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.

Conclusions

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

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About the article


Received: 2017-07-19

Revised: 2017-09-11

Accepted: 2017-09-12

Published Online: 2017-10-01

Published in Print: 2017-10-01


Ethical issues: Ethics committee approval was secured and 10 patients were consented and subsequently recruited for this pilot study.

Authorship statement: Dr. Weiner designed the study. All physicians treated patients at the study site. Dr. Weiner and Dr. Montes recruited patients, collected and analyzed the data. Niek Vanquathem prepared the manuscript. All authors reviewed the manuscript critically and approved the final version.

Sponsor and financial support: StimRelieve LLC, 1310 Park Central Boulevard South, Pompano Beach, FL33064, USA.

Conflict of interestConflict of interest statement: Dr. Richard L. Weiner: Consultant for StimRelieve LLC.Dr. Carlos Montes Garcia: Nothing to disclose.Mr. Vanquathem: Employee of the sponsor.


Citation Information: Scandinavian Journal of Pain, Volume 17, Issue 1, Pages 350–354, ISSN (Online) 1877-8879, ISSN (Print) 1877-8860, DOI: https://doi.org/10.1016/j.sjpain.2017.09.010.

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