title: Long-term effectiveness of sphenopalatine ganglion stimulation for cluster headache.
abstract: Objectives The sphenopalatine ganglion (SPG) plays a pivotal role in cluster headache (CH) pathophysiology as the major efferent parasympathetic relay. We evaluated the long-term effectiveness of SPG stimulation in medically refractory, chronic CH patients. Methods Thirty-three patients were enrolled in an open-label follow-up study of the original Pathway CH-1 study, and participated through 24 months post-insertion of a microstimulator. Response to therapy was defined as acute effectiveness in ≥ 50% of attacks or a ≥ 50% reduction in attack frequency versus baseline. Results In total, 5956 attacks (180.5 ± 344.8, range 2-1581 per patient) were evaluated. At 24 months, 45% ( n = 15) of patients were acute responders. Among acute responders, a total of 4340 attacks had been treated, and in 78% of these, effective therapy was achieved using only SPG stimulation (relief from moderate or greater pain or freedom from mild pain or greater). A frequency response was observed in 33% ( n = 11) of patients with a mean reduction of attack frequency of 83% versus baseline. In total, 61% (20/33) of all patients were either acute or frequency responders or both. The majority maintained their therapeutic response through the 24-month evaluation. Conclusions In the population of disabled, medically refractory chronic CH patients treated in this study, SPG stimulation is an effective acute therapy in 45% of patients, offering sustained effectiveness over 24 months of observation. In addition, a maintained, clinically relevant reduction of attack frequency was observed in a third of patients. These long-term data provide support for the use of SPG stimulation for disabled patients and should be considered after medical treatments fail, are not tolerated or are inconvenient for the patients.
authors.affiliation: 1 Department of Systems Neuroscience, Universitäts-Klinikum Hamburg-Eppendorf, Hamburg, Germany.|2 Department of Neurology, University Medical Center Rostock, Rostock, Germany.
authors.forename: Tim P
authors.initials: TP
authors.lastname: Jürgens
authors.affiliation: 3 Department of Clinical Physiology, Nuclear Medicine and Pet, Rigshospitalet-Glostrup, Copenhagen, Denmark.
authors.forename: Mads
authors.initials: M
authors.lastname: Barloese
authors.affiliation: 1 Department of Systems Neuroscience, Universitäts-Klinikum Hamburg-Eppendorf, Hamburg, Germany.
authors.forename: Arne
authors.initials: A
authors.lastname: May
authors.affiliation: 4 Department of Neurology, Hospital Clinico Universitario, Universidad Católica de Valencia, Valencia, Spain.
authors.forename: Jose Miguel
authors.initials: JM
authors.lastname: Láinez
authors.affiliation: 5 Headache Research Unit, Department of Neurology - CHR Citadelle, Liège University, Liège, Belgium.
authors.forename: Jean
authors.initials: J
authors.lastname: Schoenen
authors.affiliation: 6 Migraine and Headache Clinic Königstein, Königstein, Germany.
authors.forename: Charly
authors.initials: C
authors.lastname: Gaul
authors.affiliation: 7 Clinical Research, Autonomic Technologies, Inc., Redwood City, CA, USA.
authors.forename: Amy M
authors.initials: AM
authors.lastname: Goodman
authors.affiliation: 7 Clinical Research, Autonomic Technologies, Inc., Redwood City, CA, USA.
authors.forename: Anthony
authors.initials: A
authors.lastname: Caparso
authors.affiliation: 8 Danish Headache Centre, Department of Neurology, Rigshospitalet-Glostrup, University of Copenhagen, Copenhagen, Denmark.
authors.forename: Rigmor Højland
authors.initials: RH
authors.lastname: Jensen
mesh_terms: D000328:Adult; D000368:Aged; D003027:Cluster Headache / Q000175:diagnosis* / Q000503:physiopathology / Q000628:therapy*; D015331:Cohort Studies; D004599:Electric Stimulation Therapy / Q000295:instrumentation / Q000639:trends*; D005260:Female; D005500:Follow-Up Studies; D005726:Ganglia, Parasympathetic / Q000502:physiology*; D006801:Humans; D058542:Implantable Neurostimulators / Q000639:trends*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D013997:Time Factors; D016896:Treatment Outcome
keywords: Cluster headache; long-term effectiveness; neuromodulation; neurostimulation; sphenopalatine ganglion