Safety and efficacy of sphenopalatine ganglion stimulation for chronic cluster headache: a double-blind, randomised controlled trial

Goadsby, 1997, A review of paroxysmal hemicranias, SUNCT syndrome and other short-lasting headaches with autonomic features, including new cases, Brain, 120, 193, 10.1093/brain/120.1.193 2013, The International classification of headache disorders, 3rd edn (beta version), Cephalalgia, 33, 629, 10.1177/0333102413485658 Nesbitt, 2012, Cluster Headache, BMJ, 344, 10.1136/bmj.e2407 May, 2005, Cluster headache: pathogenesis, diagnosis, and management, Lancet, 366, 843, 10.1016/S0140-6736(05)67217-0 Barloese, 2015, Sleep and chronobiology in cluster headache, Cephalalgia, 35, 969, 10.1177/0333102414564892 Schor, 2017, Cluster headache: Investigating severity of pain, suicidality, personal burden, access to effective treatment, and demographics among a large International survey sample, Cephalalgia, 37, 172 Cohen, 2009, High flow oxygen for treatment of cluster headache. A randomized trial, JAMA, 302, 2451, 10.1001/jama.2009.1855 Dodick, 2004, Consensus statement: cardiovascular safety profile of triptans (5-HT1B/1D Agonists) in the acute treatment of migraine, Headache, 44, 414, 10.1111/j.1526-4610.2004.04078.x Cohen, 2007, Electrocardiographic abnormalities in patients with cluster headache on verapamil therapy, Neurology, 69, 668, 10.1212/01.wnl.0000267319.18123.d3 Silberstein, 2016, Non-invasive vagus nerve stimulation for the acute treatment of cluster headache: findings from the randomized, double-blind, sham-controlled ACT1 study, Headache, 56, 1317, 10.1111/head.12896 Goadsby, 2018, Non-invasive vagus nerve stimulation for the acute treatment of episodic and chronic cluster headache: a randomized, double-blind, sham-controlled ACT2 study, Cephalalgia, 38, 959, 10.1177/0333102417744362 Burns, 2007, Treatment of medically intractable cluster headache by occipital nerve stimulation: long-term follow-up of eight patients, Lancet, 369, 1099, 10.1016/S0140-6736(07)60328-6 Magis, 2007, Occipital nerve stimulation for drug-resistant chronic cluster headache: a prospective pilot study, Lancet Neurol, 6, 314, 10.1016/S1474-4422(07)70058-3 Leone, 2001, Stereotatic stimulation of the posterior hypothalamic gray matter in a patient with intractable cluster headache, N Engl J Med, 345, 1428, 10.1056/NEJM200111083451915 Schoenen, 2005, Hypothalamic stimulation in chronic cluster headache: a pilot study of efficacy and mode of action, Brain, 128, 940, 10.1093/brain/awh411 May, 1999, The trigeminovascular system in humans: pathophysiological implications for primary headache syndromes of the neural influences on the cerebral circulation, J Cereb Blood Flow Metab, 19, 115, 10.1097/00004647-199902000-00001 Goadsby, 1984, The peripheral pathway for extracranial vasodilatation in the cat, J Auton Nerv Syst, 10, 145, 10.1016/0165-1838(84)90053-5 Gray, 1918 Sluder, 1908, The role of the sphenopalatine (or Meckle's) ganglion in nasal headaches, NY Med J, 87, 989 Narouze, 2009, Sphenopalatine ganglion radiofrequency ablation for the management of chronic cluster headache, Headache, 49, 571, 10.1111/j.1526-4610.2008.01226.x Ansarinia, 2010, Electrical stimulation of sphenopalatine ganglion for acute treatment of cluster headaches, Headache, 50, 1164, 10.1111/j.1526-4610.2010.01661.x Schoenen, 2013, Stimulation of the sphenopalatine ganglion (SPG) for cluster headache treatment—Pathway CH-1: a randomized, sham-controlled study, Cephalalgia, 33, 816, 10.1177/0333102412473667 Asano, 2013, How do we fashion better trials for neurostimulator studies in migraine?, Neurology, 80, 694, 10.1212/WNL.0b013e3182825174 Goadsby, 2013, Analysis of occipital nerve stimulation in studies of chronic migraine and broader implications of social media in clinical trials, Cephalalgia, 33, 214, 10.1177/0333102412468680 James, 1996, An index for assessing blindness in a multi-centre clinical trial: disulfiram for alcohol cessation—a VA cooperative study, Stat Med, 15, 1421, 10.1002/(SICI)1097-0258(19960715)15:13<1421::AID-SIM266>3.0.CO;2-H Assaf, 2016, Technical and surgical aspects of the sphenopalatine ganglion (SPG) microstimulator insertion procedure, Int J Oral Maxillofac Surg, 45, 245, 10.1016/j.ijom.2015.09.023 Lipton, 1995, Guidelines for controlled trials of drugs in cluster headache, Cephalalgia, 15, 452, 10.1046/j.1468-29821995.1506452.x Gonzalez, 1975, Vasodilator system for the face, J Neurosurg, 42, 696, 10.3171/jns.1975.42.6.0696 Drummond, 1983, Facial flushing after thermocoagulation of the gasserian ganglion, J Neurol Neurosurg Psychiatry, 46, 611, 10.1136/jnnp.46.7.611 Lambert, 1984, Decreased carotid arterial resistance in cats in response to trigeminal stimulation, J Neurosurg, 61, 307, 10.3171/jns.1984.61.2.0307 May, 2001, MR-angiography in facial and other pain: neurovascular mechanisms of trigeminal sensation, J Cereb Blood Flow Metab, 21, 1171, 10.1097/00004647-200110000-00005 Knight, 2005, Patterns of fos expression in the rostral medulla and caudal pons evoked by noxious craniovascular stimulation and periaqueductal gray stimulation in the cat, Brain Res, 1045, 1, 10.1016/j.brainres.2005.01.091 Spencer, 1990, CNS projections to the pterygopalatine parasympathetic preganglionic neurons in the rat: a retrograde transneuronal viral cell body labeling study, Brain Res, 534, 149, 10.1016/0006-8993(90)90125-U Eccles, 1973, The parasympathetic secretory nerves of the nose of the cat, J Physiol, 230, 213, 10.1113/jphysiol.1973.sp010184 Goadsby, 1990, High frequency stimulation of the facial nerve results in local cortical release of vasoactive intestinal polypeptide in the anesthetised cat, Neurosci Lett, 112, 282, 10.1016/0304-3940(90)90217-W Uddman, 1993, PACAP, a VIP-like peptide, immunohistochemical localization and effect upon cat pial arteries and cerebral blood flow, J Cereb Blood Flow Metab, 13, 291, 10.1038/jcbfm.1993.36 Uddman, 1999, Helospectin-like peptides: immunochemical localization, and effects on isolated cerebral arteries and on local cerebral blood flow in the cat, J Cereb Blood Flow Metab, 19, 61, 10.1097/00004647-199901000-00007 Akerman, 2012, A translational in vivo model of trigeminal autonomic cephalalgias: therapeutic characterization, Brain, 135, 3664, 10.1093/brain/aws249 Drummond, 1988, Autonomic disturbance in cluster headache, Brain, 111, 1199, 10.1093/brain/111.5.1199 Meyer, 1970, Sphenopalatine ganglionectomy for cluster headache, Arch Otolaryngology, 92, 475, 10.1001/archotol.1970.04310050057009 Kano, 2011, Stereotactic radiosurgery for intractable cluster headache: an initial report from the North American Gamma Knife Consortium, J Neurosurg, 114, 1736, 10.3171/2010.3.JNS091843 Bratbak, 2016, Pilot study of sphenopalatine injection of onabotulinumtoxinA for the treatment of intractable chronic cluster headache, Cephalalgia, 36, 503, 10.1177/0333102415597891 Pipolo, 2010, Sphenopalatine endoscopic ganglion block in cluster headache: a reevaluation of the procedure after 5 years, Neurol Sci, 31, S197, 10.1007/s10072-010-0325-2 Jurgens, 2017, Long-term effectiveness of sphenopalatine ganglion stimulation for cluster headache, Cephalalgia, 37, 423, 10.1177/0333102416649092 Schytz, 2013, Experimental activation of the sphenopalatine ganglion provokes cluster-like attacks in humans, Cephalalgia, 33, 831, 10.1177/0333102413476370 Goadsby, 1991, Characteristics of facial nerve elicited cerebral vasodilatation determined with laser Doppler flowmetry, Am J Physiol, 260, R255 Pietzsch, 2018, Changes in medication cost observed in chronic cluster headache patients treated with sphenopalatine ganglion (SPG) stimulation: analysis based on 1-year data from the Pathway R-1 registry, Cephalalgia, 38, 1455, 10.1177/0333102418784689 Pietzsch, 2015, Cost-effectiveness of stimulation of the sphenopalatine ganglion (SPG) for the treatment of chronic cluster headache: a model-based analysis based on the Pathway CH-1 study, J Headache Pain, 16, 530, 10.1186/s10194-015-0530-8 de Coo, 2017, Non-invasive vagus nerve stimulation for acute treatment of episodic and chronic cluster headache: pooled analysis of data from two randomised, double-blind, sham-controlled clinical trials, Cephalalgia, 37, 175 Leone, 2006, Hypothalamic stimulation for intractable cluster headache: long-term experience, Neurology, 67, 150, 10.1212/01.wnl.0000223319.56699.8a