Boston Scientific Launches Trial To Evaluate Neurostimulation For Treatment Of Chronic Migraine

First Patient Treated in OPTIMISE Clinical Trial Evaluating Safety, Efficacy of Occipital Nerve Stimulation Using Precision™ System Boston Scientific Corporation (NYSE: BSX) has launched a clinical trial to determine whether occipital nerve stimulation (ONS) using the Precision™ System can safely and effectively treat chronic migraine when used in conjunction with anti-migraine medications. The OPTIMISE trial -- a multi-center, randomized, placebo-controlled study -- is expected to be used to support various regulatory approvals of this novel therapy for chronic migraine.

The first patient to undergo this procedure was treated at Mercy Hospital in Springfield, Mo., by Benjamin Lampert, M.D., using the Boston Scientific Precision System, which features multiple independent current control (MICC) technology. With ONS, a small programmable implanted device sends electrical impulses to the greater occipital nerve, which runs from the top of the spinal cord to the base of the scalp. Initial studies suggest that by stimulating the occipital nerve, it may be possible to mask the pain associated with chronic migraine1-3.

"By directly targeting the occipital nerve with neurostimulation, we are potentially able to offer patients an effective and relatively low-risk therapy," said Richard Lipton, M.D., professor of neurology and director of the Montefiore Headache Center at Albert Einstein College of Medicine in New York and principal investigator for the study. "I am excited to further evaluate the clinical utility of the Boston Scientific Precision System with MICC technology as a treatment for chronic migraine."

Migraine is a neurological disorder affecting one in 10 adults worldwide. Sufferers have headaches that last more than four hours a day with some adults experiencing headaches 15 or more days per month. Migraine is considered by the World Health Organization (WHO) to be one of the top disabling conditions worldwide. Despite the available treatment options, many migraine patients are unable to find relief.

The Precision System for chronic migraine is investigational. It is currently available as an approved treatment in the U.S., Canada, Europe and Australia as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome and intractable low back pain and leg pain.

"We believe that the Boston Scientific neurostimulation therapy for migraine has enormous potential to help migraine sufferers worldwide," said Maulik Nanavaty, president, Neuromodulation, Boston Scientific. "Launching this study highlights our continued commitment to bringing innovations in pain management to market to ensure we are meeting the needs of clinicians and patients alike."

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1Saper, J.R., Dodick, D. W., Silberstein, S. D., McCarville, S., Sun, M., Goadsby, P. J., and O. Investigators, Occipital nerve stimulation for the treatment of intractable chronic migraine headache: ONSTIM feasibility study. Cephalalgia, 2011. 31(3): p. 271-285.
2Bennett, D., Webster, Lynn, Lampert, Benjamin A., Lubenow, Timothy R., Sharan, Ashwini, Whiten, Darren, Jaax, Kristen N., Occipital nerve stimulation: surgical technique and outcomes from the PRISM study of ONS for drug-refractory migraine, in 13th North American Neuromodulation Society Annual Meeting. 2009: Las Vegas, NV.
3Silberstein, S., Dodick, D., Saper, J., Huh, B., Reed, K., Narouze, S., Bacon, D., Mogilner, A., Banks, J., Cady, R., Black, S., Slavin, K., Goldstein, J. Markley, H. Deer, T., Levy, R., Mekhail, N., The safety and efficacy of occipital nerve stimulation for the management of chronic migraine, in 15th Congress of the International Headache Society. 2011: Berlin, Germany.
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