International Journal of Oral and Maxillofacial Surgery
Clinical PaperOral MedicineTechnical and surgical aspects of the sphenopalatine ganglion (SPG) microstimulator insertion procedure
Section snippets
Materials and methods
Ninety-nine patients diagnosed with cluster headache (International Classification of Headache Disorders 2nd edition criteria (ICHD-2)) by a physician specializing in headache care (headache neurologist, pain specialist, and general neurologist), who presented for insertion of an SPG microstimulator through May 2014, were analyzed. These 99 patients included 32 Pathway CH-1 study patients who were part of a previously reported cohort,19 11 continued access Pathway CH-1 patients, and 56 patients
Results
Ninety-nine cluster headache patients who presented for insertion of an SPG microstimulator as a part of either the Pathway CH-1 study or the Pathway R-1 registry were analyzed. Baseline patient characteristics are provided in Table 1.
The average duration of the initial insertion procedure was 80 min (range 25–175 min). Ninety-six of the 99 patients had a microstimulator placed within the PPF during their initial procedure.
Follow-up procedures occurred for a variety of reasons, including
Discussion
The Pulsante Microstimulator insertion procedure is a novel procedure designed to place the stimulating electrodes near the SPG. The microstimulator is designed to fit the curvature of the maxilla and to allow placement of the integral lead proximate to the SPG. The remote powering avoids the need for a battery replacement procedure. To date, follow-up procedures have only been needed for cases of initial misplacement or removal; no late lead migrations or breakages have been observed.
The
Funding
The Pathway CH-1 and Pathway R-1 studies were supported by Autonomic Technologies, Inc.
Competing interests
Anthony Caparso is an employee of Autonomic Technologies, Inc. All other authors of this article have no conflicts of interest. There are no financial or personal relationships with other people or organizations that could inappropriately have influenced (biased) their actions.
Ethical approval
Ethical approval was given for the Pathway CH-1 and Pathway R-1 studies: Ethik-Kommission der Medizinischen Fakultät der Universität Duisburg-Essen; De Videnskabsetiske Komiteer for Region Hovedstaden Regionsgarden (H-2-2010-092); Ethik-Kommission der Ärztekammer Hamburg (PVMP 3675); Comité d’Ethique CHR de la Citadelle (1112); Comité de Protection des Personnes Sud Mediterranée V (2010-A00896-33); Fundación de Investigación del Hospital Clínico Universitario de Valencia; Ethik-Kommission
Patient consent
Not required.
Acknowledgements
The authors would like to acknowledge the additional surgeons who have implanted the Pulsante Microstimulator System: Denys Fontaine, Thomas Hoffmann, Martin Kahn, Götz Lehnerdt, Lars Lemcke, Mariano Marqués Mateo, Sandrine Machiels, Oliver Müller, Heidi Olze, Kai Wermker, and Alain Wilmont. The authors would also like to acknowledge the neurologists who have participated in the Pathway CH-1 and Pathway R-1 studies. Finally, the authors would like to acknowledge Olivia Bigazzi, Amy Goodman, and
References (29)
Pathophysiology of cluster headache: a trigeminal autonomic cephalgia
Lancet Neurol
(2002)- et al.
Neurobiology of migraine
Neuroscience
(2009) - et al.
Value of intra- and post-operative cone beam computed tomography (CBCT) for positioning control of a sphenopalatine ganglion neurostimulator in patients with chronic cluster headache
J Craniomaxillofac Surg
(2015) - et al.
Recovery of neurosensory function following orthognathic surgery
J Oral Maxillofac Surg
(1990) The International Classification of Headache Disorders: 2nd edition
Cephalalgia
(2004)- et al.
The incidence and prevalence of cluster headache: a meta-analysis of population-based studies
Cephalalgia
(2008) Clinical anatomy of the masticatory apparatus and peripharyngeal spaces
(1995)Netter's head and neck anatomy for dentistry
(2006)Orbital passage of pterygopalatine ganglion efferents to paranasal sinuses and nasal mucosa in man
Cells Tissues Organs
(2003)- et al.
The cerebrovascular parasympathetic innervation
Cerebrovasc Brain Metab Rev
(1993)
Migraine—current understanding and treatment
N Engl J Med
Unitary hypothesis for multiple triggers of the pain and strain of migraine
J Comp Neurol
The trigeminovascular system in humans: pathophysiologic implications for primary headache syndromes of the neural influences on the cerebral circulation
J Cereb Blood Flow Metab
The role of the sphenopalatine (or Meckle's) ganglion in nasal headaches
New York Medical Journal
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