Occipital Chronic Migraine Treatment Shows Promise
Medtronic says new migraine treatment Occipital nerve stimulation shows promise and will present the data at American Headache Society Meeting.
Medtronic, Inc. (NYSE: MDT) today announced that data from a multi-center, prospective, randomized, single-blinded, controlled investigational study using its neurostimulation system to stimulate the occipital nerves as a potential approach to treating medically refractory chronic migraines will be presented during a late-breaking session at the annual scientific meeting of the American Headache Society (AHS) tomorrow in Boston. This study, called Occipital Nerve Stimulation for the Treatment of Intractable Migraine (ONSTIM), included patients who have regularly experienced 15 or more headache days per month that were not responsive to conventional medical therapies.
The ONSTIM study, sponsored by Medtronic and conducted under an investigational device exemption (IDE), collected electronic diary data from 66 patients from nine centers who were followed for three months. The data to be reported at the AHS meeting include the average change in the number of headache days per month, overall pain intensity and the responder rate based on at least a 50 percent reduction in headache days per month or at least a three-point reduction in overall pain intensity.
"The ONSTIM results suggest that occipital nerve stimulation, or ONS, may be a promising therapy option for individuals who have not had success in treating their chronic migraine and as a result are living with the painful and often debilitating symptoms," said Dr. Joel R. Saper, M.D., founder and director of the Michigan Head Pain and Neurological Institute, Ann Arbor, Mich., and principal investigator for the ONSTIM study. "While ONS for chronic migraine requires additional clinical evaluation, our early experience in this study is encouraging and indicates that ONS could possibly help some chronic migraine patients who have exhausted other treatment options."
In the study, thin lead wires were placed under the skin near the occipital nerves, which arise from the spinal cord and branch out across the back of the head carrying sensory signals from that region to the brain. The leads were connected to an implanted Medtronic neurostimulator that delivered controlled electrical pulses to the occipital nerves. Patients were randomized to three groups to receive: either a neurostimulator and have the ability to control the level of stimulation; or a neurostimulator as part of a device control group; or only standard medical management instead of an ONS implant.