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

• Published in: Journal of headache and pain Vol. 11; no. 1; pp. 23 - 31
• Main Authors: Fontaine, Denys, Lazorthes, Yves, Mertens, Patrick, Blond, Serge, Géraud, Gilles, Fabre, Nelly, Navez, Malou, Lucas, Christian, Dubois, Francois, Gonfrier, Sebastien, Paquis, Philippe, Lantéri-Minet, Michel
• Format: Journal Article
• Language: English
• Published: Milan Springer Milan 01.02.2010; Springer; Springer Nature B.V
• Subjects: Adult; Biological and medical sciences; Brain surgery; Clinical trials; Cluster Headache - psychology; Cluster Headache - therapy; Cross-Over Studies; Deep Brain Stimulation - methods; Double-Blind Method; Electrodes, Implanted - adverse effects; Female; Follow-Up Studies; Functional Laterality - physiology; Headaches; Humans; Hypothalamus - physiology; Immunomodulators; Internal Medicine; Male; Medical sciences; Medicine; Medicine & Public Health; Middle Aged; Neurology; Original; Pain management; Pain Measurement - methods; Pain Medicine; Pharmacology. Drug treatments; Quality of Life; Time Factors; Transplants & implants; Treatment Outcome; Vascular diseases and vascular malformations of the nervous system; Headache; Cluster headache; Pain modulation; Randomized trial; Hypothalamus; Deep brain stimulation; Nervous system diseases; Pain modulations; Central nervous system; Cardiovascular disease; Encephalon; Cerebral disorder; Vascular disease; Refractory; Pain; Modulation; Central nervous system disease; Placebo; Safety; Cerebrovascular disease
• ISSN: 1129-2369; 1129-2377
• DOI: 10.1007/s10194-009-0169-4

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).