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The Journal of Headache and Pain logoLink to The Journal of Headache and Pain
. 2009 Nov 21;11(1):23–31. doi: 10.1007/s10194-009-0169-4

Safety and efficacy of deep brain stimulation in refractory cluster headache: a randomized placebo-controlled double-blind trial followed by a 1-year open extension

Denys Fontaine 1, Yves Lazorthes 2, Patrick Mertens 3, Serge Blond 4, Gilles Géraud 5, Nelly Fabre 5, Malou Navez 6, Christian Lucas 7, Francois Dubois 8, Sebastien Gonfrier 9, Philippe Paquis 1, Michel Lantéri-Minet 10,11,✉
PMCID: PMC3452182  PMID: 19936616

Abstract

Chronic cluster headache (CCH) is a disabling primary headache, considering the severity and frequency of pain attacks. Deep brain stimulation (DBS) has been used to treat severe refractory CCH, but assessment of its efficacy has been limited to open studies. We performed a prospective crossover, double-blind, multicenter study assessing the efficacy and safety of unilateral hypothalamic DBS in 11 patients with severe refractory CCH. The randomized phase compared active and sham stimulation during 1-month periods, and was followed by a 1-year open phase. The severity of CCH was assessed by the weekly attacks frequency (primary outcome), pain intensity, sumatriptan injections, emotional impact (HAD) and quality of life (SF12). Tolerance was assessed by active surveillance of behavior, homeostatic and hormonal functions. During the randomized phase, no significant change in primary and secondary outcome measures was observed between active and sham stimulation. At the end of the open phase, 6/11 responded to the chronic stimulation (weekly frequency of attacks decrease >50%), including three pain-free patients. There were three serious adverse events, including subcutaneous infection, transient loss of consciousness and micturition syncopes. No significant change in hormonal functions or electrolytic balance was observed. Randomized phase findings of this study did not support the efficacy of DBS in refractory CCH, but open phase findings suggested long-term efficacy in more than 50% patients, confirming previous data, without high morbidity. Discrepancy between these findings justifies additional controlled studies (clinicaltrials.gov number NCT00662935).

Keywords: Cluster headache, Deep brain stimulation, Hypothalamus, Headache, Pain modulation, Randomized trial

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Acknowledgments

We thank Sophie Tezenas du Montcel who kindly reviewed the statistical analysis. Study supported by grant from the Programme Hospitalier de Recherche Clinique and promoted by the Centre Hospitalier Universitaire de Nice. Stimulators have been purchased from Medtronic, which had no role in the study, but provided funds for the meetings of the investigators.

Contributor Information

Denys Fontaine, Email: fontaine.d@chu-nice.fr.

Michel Lantéri-Minet, Phone: +33-492037946, FAX: +33-492038469, Email: lanteri-minet.m@chu-nice.fr.

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