The American Food and Drug Administration (the equivalent of our National Medicines Safety Agency) has just given its agreement to a small Belgian company, Cefaly technology, for the latter to launch its anti-migraine tiara on the American market. This company, which works in the field of muscle stimulation applied to sports medicine, has developed the first medical device capable of preventing migraines.
The innovative idea was to apply the principle of external stimulation, whereas neurostimulant treatments previously involved the implantation of electrodes internally, in particular in the spinal cord for the treatment of chronic pain. An idea that the Food and Drug Administration deemed sufficiently innovative to authorize the Belgian company to market its anti-migraine tiara in the United States.
Electrodes on the forehead
The principle of the device is to activate by an electrode which is placed on the forehead, the trigeminal nerve which runs under the forehead and transmits the sensation of pain to the brain.
“In the United States, a new, non-invasive and non-drug treatment is immediately perceived as positive, while in Europe, the drug, and the already proven methods, remain the benchmark” explains Pierre Rigaux, founding physician of the company.
Migraine is the most intense and painful, even disabling form of headache. This neurological disease affects 15% of the world’s population. And for one in four migraine sufferers, the severity of the attacks has a significant impact, causing pain for 48 hours in a row.
Although it does not claim to treat migraine, the electrode device can greatly reduce the consumption of pain-relieving drugs and can slow the progression of episodic migraines into chronic migraines, the most disabling. It has been marketed in Europe since 2009.
