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The Journal of Headache and Pain

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Open Access 01-12-2018 | Research article

Sphenopalatine ganglion stimulation for cluster headache, results from a large, open-label European registry

Authors: Mads Barloese, Anja Petersen, Philipp Stude, Tim Jürgens, Rigmor Højland Jensen, Arne May

Published in: The Journal of Headache and Pain | Issue 1/2018

Abstract

Background

Cluster headache (CH) is a disabling primary headache disorder characterized by severe periorbital pain. A subset of patients does not respond to established pharmacological therapy. This study examines outcomes of a cohort of mainly chronic CH patients treated with sphenopalatine ganglion (SPG) stimulation.

Methods

Patients were followed in an open-label prospective study for 12 months. Ninety-seven CH patients (88 chronic, 9 episodic) underwent trans-oral insertion of a microstimulator targeting the SPG. Patients recorded stimulation effect prospectively for individual attacks. Frequency, use of preventive and acute medications, headache impact (HIT-6) and quality of life measures (SF-36v2) were monitored at clinic visits. Per protocol, frequency responders experienced ≥ 50% reduction in attack frequency and acute responders treated ≥ 50% of attacks. HIT-6 responders experienced an improvement ≥ 2.3 units and SF-36 responders ≥ 4 units vs. baseline.

Results

Eighty-five patients (78 chronic, 7 episodic) remained implanted and were evaluated for effectiveness at 12 months. In total, 68% of all patients were responders, 55% of chronic patients were frequency responders and 32% of all patients were acute responders. 67% of patients using acute treatments were able to reduce the use of these by 52% and 74% of chronic patients were able to stop, reduce or remain off all preventive medications. 59% of all patients were HIT-6 responders, 67% were SF-36 responders.

Conclusions

This open-label registry corroborates that SPG stimulation is an effective therapy for CH patients providing therapeutic benefits and improvements in use of medication as well as headache impact and quality of life.

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Headache Classification Committee of the International Headache Society (IHS) (2013) The international classification of headache disorders, 3rd edition (beta version). Cephalalgia 33:629–808. https://doi.org/10.1177/0333102413485658 CrossRef

Jensen RM, Lyngberg A, Jensen RH (2007) Burden of cluster headache. Cephalalgia 27:535–541. https://doi.org/10.1111/j.1468-2982.2007.01330.x CrossRefPubMed

Gaul C, Finken J, Biermann J, Mostardt S, Diener H-C, Müller O et al (2011) Treatment costs and indirect costs of cluster headache: a health economics analysis. Cephalalgia 31:1664–1672. https://doi.org/10.1177/0333102411425866 CrossRefPubMed

Matharu MS, Goadsby PJ (2008) Trigeminal autonomic Cephalalgias: diagnosis and management. In: Silberstein SD, Lipton R, Dodick D (eds) Wolff’s headache other head pain, 8th edn. Oxford University Press, New York

Lanteri-Minet M, Silhol F, Piano V, Donnet A (2011) Cardiac safety in cluster headache patients using the very high dose of verapamil (≥ 720 mg/day). J Headache Pain 12:173–176. https://doi.org/10.1007/s10194-010-0289-x CrossRefPubMedPubMedCentral

Mitsikostas DD, Edvinsson L, Jensen RH, Katsarava Z, Lampl C, Negro A et al (2014) Refractory chronic cluster headache: a consensus statement on clinical definition from the European headache federation. J Headache Pain 15:79. https://doi.org/10.1186/1129-2377-15-79 CrossRefPubMedPubMedCentral

Pedersen JL, Barloese M, Jensen RH (2013) Neurostimulation in cluster headache: a review of current progress. Cephalalgia 33:1179–1193. https://doi.org/10.1177/0333102413489040 CrossRefPubMed

Schoenen J, Jensen RH, Lantéri-Minet M, Láinez MJ, Gaul C, Goodman AM et al (2013) Stimulation of the sphenopalatine ganglion (SPG) for cluster headache treatment. Pathway CH-1: a randomized, sham-controlled study. Cephalalgia 33:816–830. https://doi.org/10.1177/0333102412473667 CrossRefPubMedPubMedCentral

Jürgens TP, Barloese M, May A, Láinez JM, Schoenen J, Gaul C et al (2017) Long-term effectiveness of sphenopalatine ganglion stimulation for cluster headache. Cephalalgia 37:423–434. https://doi.org/10.1177/0333102416649092 CrossRefPubMed

10.

Barloese MCJ, Jürgens TP, May A, Lainez JM, Schoenen J, Gaul C et al (2016) Cluster headache attack remission with sphenopalatine ganglion stimulation: experiences in chronic cluster headache patients through 24 months. J Headache Pain 17:67. https://doi.org/10.1186/s10194-016-0658-1 CrossRefPubMedPubMedCentral

11.

Jürgens TP, Schoenen J, Rostgaard J, Hillerup S, Láinez MJ, Assaf AT et al (2014) Stimulation of the sphenopalatine ganglion in intractable cluster headache: expert consensus on patient selection and standards of care. Cephalalgia 34:1100–1110. https://doi.org/10.1177/0333102414530524 CrossRefPubMed

12.

Assaf AT, Hillerup S, Rostgaard J, Puche M, Blessmann M, Kohlmeier C et al (2016) Technical and surgical aspects of the sphenopalatine ganglion (SPG) microstimulator insertion procedure. Int J Oral Maxillofac Surg 45:245–254. https://doi.org/10.1016/j.ijom.2015.09.023 CrossRefPubMed

13.

Smelt AFH, Assendelft WJJ, Terwee CB, Ferrari MD, Blom JW (2014) What is a clinically relevant change on the HIT-6 questionnaire? An estimation in a primary-care population of migraine patients. Cephalalgia 34:29–36. https://doi.org/10.1177/0333102413497599 CrossRefPubMed

14.

Hays RD, Morales LS (2001) The RAND-36 measure of health-related quality of life. Ann Med 33:350–357CrossRefPubMed

15.

Silberstein S, Tfelt-Hansen P, Dodick DW, Limmroth V, Lipton RB, Pascual J et al (2008) Guidelines for controlled trials of prophylactic treatment of chronic migraine in adults. Cephalalgia 28:484–495. https://doi.org/10.1111/j.1468-2982.2008.01555.x CrossRefPubMed

16.

Dworkin RH, Turk DC, McDermott MP, Peirce-Sandner S, Burke LB, Cowan P et al (2009) Interpreting the clinical importance of group differences in chronic pain clinical trials: IMMPACT recommendations. Pain 146:238–244. https://doi.org/10.1016/j.pain.2009.08.019 CrossRefPubMed

17.

Barloese M, Lund N, Petersen A, Rasmussen M, Jennum P, Jensen R (2015) Sleep and chronobiology in cluster headache. Cephalalgia 35:969–978. https://doi.org/10.1177/0333102414564892 CrossRefPubMed

18.

Pietzsch JB, Garner A, Gaul C, May A (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. https://doi.org/10.1186/s10194-015-0530-8 CrossRefPubMed

Title: Sphenopalatine ganglion stimulation for cluster headache, results from a large, open-label European registry
Authors: Mads Barloese
Anja Petersen
Philipp Stude
Tim Jürgens
Rigmor Højland Jensen
Arne May
Publication date: 01-12-2018
Publisher: Springer Milan
Published in: The Journal of Headache and Pain / Issue 1/2018
Print ISSN: 1129-2369
Electronic ISSN: 1129-2377
DOI: https://doi.org/10.1186/s10194-017-0828-9

At a glance: The STEP trials

Springer Medicine

Sphenopalatine ganglion stimulation for cluster headache, results from a large, open-label European registry

Abstract

Background

Methods

Results

Conclusions

At a glance: The STEP trials

Springer Medicine

Abstract

Background

Methods

Results

Conclusions

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