Positive results from study of Genesis Neurostimulator (St Jude Medical) in patients with Migraine

Results from a large-scale study of peripheral nerve stimulation (PNS) of the occipital nerves using the Genesis neurostimulation system, from St Jude Medical, in patients suffering from chronic Migraine show a significant reduction in pain, headache days and migraine-related disability. Conducted at 15 medical centers in the US, the study followed 157 participants who, on average, suffered from headache approximately 21 days per month. Participants were implanted with the Genesis neurostimulator and randomly assigned to an active or control group for 12 weeks. The active group received stimulation immediately upon implantation, while patients in the control group did not receive stimulation until after the first 12 weeks.

At 12 weeks, patients receiving PNS therapy reported an average of six fewer headache days a month. Patients also reported a 43 percent improvement in overall disability scores, as measured using the Migraine Disability Assessment questionnaire (MIDAS). Although statistical significance was demonstrated across most measures, it was not observed for the primary endpoint (defined as the difference in the percentage of patients in the active group versus control who achieved 50 percent or greater pain reduction at 12 weeks). However, patients in the active group were more likely than control patients to experience 30 percent or greater pain reduction, which is considered clinically meaningful. The study results were published online by Cephalalgia.

see "Safety and efficacy of peripheral nerve stimulation of the occipital nerves for the management of chronic migraine: Results from a randomized, multicenter, double-blinded, controlled study" Stephen D Silberstein et al. Cephalalgia 0333102412462642, October 3, 2012 doi:10.1177/0333102412462642