Sep 182011
 

Migraine is a highly prevalent neurological disorder, affecting more than 10% of people (6% of men and 18% of women) worldwide. It is not surprising, therefore, that all three of the major neurotech device manufacturers, Medtronic, St. Jude Medical, and Boston Scientific, have evaluated their implantable stimulators for treatment of his chronic condition. Multiple areas have been targeted for treating migraine; with most common ones being the occipital nerves and the cerebral cortex. The latter approach is usually accomplished non-invasively with the transcranial magnetic stimulation and is most helpful for patients whose migraines begin with an aura, a condition characterized by flashing lights or other visual (or sometimes sensory, motor or verbal) disturbance. The occipital nerve stimulation is more generally applicable to migraine sufferers, and involves a chronic implantation of the stimulating device. The clinical trials have been performed to see whether any of the devices could clear at least one of two FDA-mandated thresholds: a 50% reduction in migraine severity or a 50% reduction in migraine frequency. Boston Scientific’s pivotal trial PRISM was completed in 2009, showing no significant improvements. Medronic’s pivotal trial ONSTIM was completed in 2010, indicating that 39% of patients achieved 50% reduction in migraine frequency. St. Jude Medical’s pivotal trial ended in June 2011 and was, perhaps, the most successful of the three: they reported an overall 28% reduction in migraine frequency and 42% reduction in migraine severity. Although these results are insufficient for the FDA clearance, the St. Jude Medical’s Genesis device was able to receive the European CE mark approval  in September 2011. This gives the first-mover advantage to St. Jude Medical in Europe, but the battle for the lucrative US migraine market is still waging on.

  4 Responses to “Occipital nerve stimulation for migraine”

  1. [...] Cortical and spinal neural implants are among the most invasive and, therefore, always require a PMA approval. In comparison, the “Cranial Electrotherapy Stimulator” (CES) devices, are implanted under the scalp and pose fewer surgical risks. Until recently, they required only a 510(k) clearance, and such relaxed approval process resulted in their multiple applications for neurological and psychiatric disorders, such as anxiety, depression, insomnia, chronic pain, and migraine. [...]

  2. From where can I get this device………How much it cost…..Can be used at home…….Do you have any Video of how to use it……..Is it safe??????

    Regards,
    Bassam Iseed.

  3. My girlfriend has resently had a nerve stimulator put in for leg pain ,and lower back pain. Since the operation she has had the worst head ache in the back of her head. Her surgen seems to be unconcerned by any of her post opp. problems. do you think this could be a side affect ??? She has other problems ,but this one is the worst .the head aches bring tears to her eyes.. Please respond with any thoughts you have.

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