Deep brain stimulation (DBS) has been used to treat severe refractory CCH (srCCH), 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 srCCH. The randomized phase compared active and sham stimulation during 1-month periods, and was followed by a 1-year open phase.
Evaluation included the weekly attacks frequency (primary outcome), pain intensity, sumatriptan injections, emotional impact and quality of life. Tolerance was assessed by active surveillance of behaviour, homeostatic and hormonal functions. No significant change was observed between active and shame stimulation during the randomized phase. At the end of the open phase, 6/11 responded to the chronic stimulation (weekly frequency of attacks decreases >50%) including 3 pain-free patients. There were 3 serious adverse events including subcutaneous infection, transient loss of consciousness and micturition syncopes. No significant change in hypothalamic functions was observed. Randomized phase findings of this study do not support the efficacy of DBS in srCCH but open phase findings confirm previous data obtained in non-controlled conditions, without high morbidity. Discrepancy between these findings justifies additional controlled studies. The Prize has been delivered during the XXV National Congress of SISC (Riccione 8th October 2011) to Michel Lantéri-Minet (Département d’Evaluation et Traitement de la Douleur Pole Neuroscience Cliniques du CHU de Nice – France).
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