(dailyRx News) US regulators recently gave the green light for the first device intended to treat pain during a migraine headache.
The US Food and Drug Administration (FDA) has approved the Cerena Transcranial Magnetic Stimulator (TMS), which releases magnetic energy to stimulate part of the brain in order to relieve pain.
The TMS is available by prescription for patients who have chronic migraines preceded by an aura, or sensations and blind spots.
Migraine headaches usually last for several hours, but sometimes can last for several days. Individuals who have migraines often experience severe pain, nausea and vomiting.
According to the FDA, about one third of people who have migraines experience an aura, or a warning sign that a migraine is about to start.
Auras can consist of flashes of light, blind spots in the vision field or other sensations.
The FDA approved marketing of this new device after examining a clinical trial of 201 patients who experienced migraines with auras.
According to that study, 38 percent of participants used the Cerena TMS while experiencing a migraine and were pain-free within two hours. Only 17 percent of patients in the control group reported the same amount of success.
About one third of Cerena TMS users were free of pain 24 hours after use, while only 10 percent of the control group was.
Three participants in the study reported a sinus infection, vertigo (dizziness and spinning) or inability to speak or understand language.
According to the FDA, patients who have magnetic metal implanted in their head, neck or upper body, or who have devices like pacemakers or deep brain stimulators, should not use this device.
It is also recommended that people with epilepsy or a history of seizures should avoid the Cerena TMS.
The device is made by eNeura Therapeutics.