FDA Approves First Device that Can Relieve Migraine Headaches
By Julie S | Dec 15, 2013 11:37 AM EST
The U.S Food and Drug Administration (FDA) approved on Friday the first device that can help relieve migraine headaches. The Cerena Transcranial Magnetic Stimulator (TMS) device is good news for patients who are looking for more options on this painful condition.
Migraine is a disorder characterized by series of severe headaches. People who experience this often complain of a throbbing pain on one side of the head. Sometimes, aside from the headaches, they also experience nausea, vomiting, and extreme sensitivity to light and sound. The condition usually last for hours or days. It is not yet determined what really triggers migraine but earlier studies suggest it can be the body’s reaction to emotional stress, food and chemical allergy, hunger or dehydration, poor sleep, hormonal changes, and more.
There are two types of migraine: with aura and no aura. Migraine with aura is a warning sign characterized with visual disturbances prior the attack. Some reports seeing zigzag lines or blind spots before the migraine.
“Millions of people suffer from migraines and this new device represents a new treatment option for some patients,” said Christy Foreman, director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health.
TMS, manufactured by eNeura Therapeutics, is designed for those who have migraine with aura to prevent the migraine attack or lessen its pain. The user just needs to hold the device against the back of the head and press the button that will activate the magnetic energy which will be sent to the brain.
The researchers tested the device on 201 patients who had moderate to strong migraine headaches. About 56 percent of the participants were able to use the device at least one during the study.
About 38 percent of the participants reported that they didn’t feel any pain for two hours after using TMS while 34 percent did not feel any pain for 24 hours.
The study clarified that the device was not designed to treat other symptoms of migraine and focuses more on those with migraine with aura. There were also side effects reported such as sinusitis, aphasia, vertigo, and dizziness.