Two interesting studies are being reported at the ongoing annual scientific meeting of the American Headache Society (AHS) in Boston. The first study, dubbed Occipital Nerve Stimulation for the Treatment of Intractable Migraine (ONSTIM), has evaluated Medtronic‘s Synergy® neurostimulation device.
Medtronic, predictably, is quite excited about the possibility that occipital nerve stimulation one day might become a treatment option for migraine sufferers who are resistant to all other 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. A positive response was defined as at least a 50 percent reduction in the number of headache days in a month, or a reduction in the pain intensity of at least three points on a standard 0-10 pain scale. In addition to evaluating the efficacy of ONS therapy, the ONSTIM trial was designed to follow patients out to three years related to safety.
In other news from the headache front, investigators from the Ohio State University Medical Center are continuing to test a noninvasive portable transcranial magnetic stimulator (TMS) from Sunnyvale, CA based Neuralieve Inc., as a potential treatment for migraines. First reported by us back in June 2006, the device seems to be effective in not only reducing the symptomatology of migraines, but actually in treating them.
The press release from Ohio State explains:
Results of the study, to be presented Friday (6/27) at the annual American Headache Society meeting in Boston, found that the experimental device is safe and effective in eliminating headaches when administered during the onset of the migraine…
Of the 164 patients involved in the multi-center, randomized clinical trial receiving TMS treatment, 39 percent were pain free at the two-hour post-treatment point, compared to 22 percent in the group receiving “sham” pulses. There were no differences reported related to adverse reactions between the two groups.
Medtronic press release: Medtronic Announces First Clinical Data on Occipital Nerve Stimulation for Chronic Migraine to be Presented at American Headache Society Meeting …
Ohio State University Medical Center press release: Portable Device Effective in Zapping Away Migraine Pain …
Neuralieve press release: New Technology Provides Drug-Free Approach to Treat Migraine…
Medgadget archives: TMS
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