Belgium-based Cefaly Technologies already secured FDA approval for its headband-like device that stimulates the trigeminal nerve to reduce the frequency and intensity of migraines in March 2014. But now it has revealed positron emission tomography (PET) scan data showing that its Cefaly device can aid areas of the brain in returning to their normal metabolic rate in migraine patients.

The European study looked at 28 patients who reported having at least four migraines per month. These patients were monitored over three months as they used Cefaly once a day for 20 minutes.

The idea was to better understand the short- and medium-term metabolic changes in the areas of the brain involved in migraine: the orbitofrontal cortex and the rostral cingulate, which are involved in decision-making and emotional behavior. In migraine patients, those areas of the brain tend to be sub-metabolic compared to people without migraines.

Researchers found via the PET imaging that use of the Cefaly device normalized the metabolic activity of the orbitofrontal cortex and rostral cingulate. These results were presented last month at the Euro Head Pain conference in Valencia, Spain.

“This is a major breakthrough in understanding the mechanism of action of the device on the central nervous system,” said Cefaly CEO Dr. Pierre Rigaux in a statement. “It will help us take developments in this non-invasive, drug-free, technology even further.”

He added, “The modifications observed through the PET scan reinforce the strong clinical data on safety and efficacy that led to the FDA approval.”

The FDA approval was based upon randomized, double-blind clinical data from five university clinics in Belgium and a patient satisfaction study of more than 2,300 Cefaly users in France.


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