On December 13, 2013, the U.S. Food and Drug Administration (FDA) announced the approval of a new acute migraine therapy using magnetic stimulation. The procedure is known as "Cerena transcranial magnetic stimulation (TMS)." This is the first approval of a medical device specifically authorized for the treatment of migraine headaches, particularly migraine with aura.

Migraine auras are neurological symptoms that occur before the headache phase and typically develop gradually over 30 to 60 minutes. The most common symptoms are visual disturbances such as zigzag lines, flickering lights, and visual field defects. However, complex auras also exist. These can include sensory disturbances or paralysis of one side of the body, or even drowsiness leading to unconsciousness. Many neuropsychological disturbances, such as difficulty concentrating, memory loss, word-finding difficulties, or emotional changes, can also be symptoms of a migraine aura.

“Millions of people suffer from migraines and the new device represents a new treatment option for a subset of patients,” said Christy Foreman, director of the FDA’s Division of Medical Device Evaluation, in a statement from the agency .

The device is currently only approved for the treatment of migraine headaches with aura. It is prescribed by a doctor. The device is used by positioning it on the back of the head. A magnetic pulse is then released by pressing a button. This pulse stimulates the cerebral cortex in the occipital region. The procedure is based on the idea that the magnetic pulse counteracts the electrical changes in the cerebral cortex and thus blocks the aura.

The approval is based on a study of 201 patients suffering from moderate to severe migraine with aura. Of those using the magnetic stimulator, 38% reported a significant reduction in pain after two hours. In a control group without stimulation, only 17% of patients reported improvement. 34% of users reported being pain-free after 24 hours. However, it remains unclear whether this sustained pain relief could also be due to a placebo effect.

The FDA noted that dizziness can occur as a side effect. However, overall, side effects are very mild and their occurrence is highly unlikely. There are only a few reports of side effects such as sinusitis, speech difficulties, and vertigo. The FDA recommends that the device not be used more than once every 24 hours. It is only approved for use by individuals over 18 years of age. The device should not be used by patients who have metallic objects in their head or upper body, including pacemakers or brain stimulators. Patients with a history of epilepsy or implants should also not use the device.

To our knowledge, the device is not yet approved in Germany. Based on the available data, its effectiveness appears to be limited.