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Help Might Be on the Horizon for People who Suffer from Chronic Migraine

SRLast month, the private company StimRelieve, LLC, received approval from the United States Food & Drug Administration (FDA) to conduct a clinical trial of a stimulation device to treat chronic migraine. Called the StimRelieve Halo Migraine System, it is implanted under the skin and uses wireless neurostimulators to treat chronic migraine—migraine 15 or more days per month—that has not responded to other treatment.

Commenting on this news, NHF board member Mark Green, MD, a professor of neurology at the Icahn School of Medicine at Mount Sinai, New York, noted that currently the only FDA-approved treatment for chronic migraine is onabotulinumtoxinA (Botox) and that trials of multiple drugs used for migraine have resulted in mixed results in chronic migraine studies.

Additionally, Dr. Green said, many headache specialists have used occipital or supraorbital nerve stimulation, or combine both regions, for chronic migraine treatment, but this approach involves surgical implantation of the electrodes and the device. StimRelieve is different in that it is smaller than most other devices, is implanted through an injection, and the stimulation is wireless. The battery pack is worn on the ear rather than under the skin.

A company press release indicated the goal of the study is to achieve a 30% reduction in headaches with no increase in medication at 3 months.

“The results of these studies are awaited with interest, as a novel and relatively simple treatment not involving medication for chronic migraine would be a welcome addition to the current limited armamentarium of existing therapies,” Dr. Green said.

For more information about the StimRelieve clinical trials, visit

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