migraines

FDA Approves New Magnet Device to Treat Migraines

The U.S. Food and Drug Administration has approved the first device aimed at easing the pain of migraines preceded by aura — sensory disturbances that occur just before an attack.

The Cerena Transcranial Magnetic Stimulator would be obtained through prescription, the FDA said in a statement released Friday. Patients use both hands to hold the device against the back of their head and press a button so that the device can release a pulse of magnetic energy. This pulse stimulates the brain’s occipital cortex, which may stop or ease migraine pain.

“Millions of people suffer from migraines, and this new device represents a new treatment option for some patients,” Christy Foreman, director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health, said in the statement.

The agency’s approval is based on a trial involving 201 patients who had suffered moderate-to-strong migraine with aura. One hundred and thirteen of the patients tried treating their migraines while an attack was in progress, and it was the testimony of this group that led to the approval of the new device, the FDA said.

More than a third (38 percent) of people using the stimulator said they were pain-free two hours later, compared to 17 percent of patients who did not use the device. A full day after the onset of migraine, nearly 34 percent of device users said they were pain-free, compared to 10 percent of people who hadn’t used the device.

Two experts welcomed the news of the approval.

“The Cerena TMS is another tool in the battle to relieve migraines,” said Dr. Mark Green, director of Headache and Pain Management at the Mount Sinai Medical Center in New York City. “Experience with TMS over the past few years have shown that these agents have the potential to reduce the pain of an attack without the use of medications, or in addition to medical treatment.”

Dr. Noah Rosen is director of the Headache Center at North Shore-LIJ’s Cushing Neuroscience Institute, in Manhasset NY. He said that, “although only 20 percent of migraneurs suffer from an aura associated with their headaches, they suffer significantly. Although this device is unwieldy, it may be a preferred choice by those who don’t want [drug] treatment.”

Side effects from the device were rare, the FDA said, but included “single reports of sinusitis, aphasia (inability to speak or understand language) and vertigo.”

The new device is approved only for use by those aged 18 or older, and should not be used by people with suspected or diagnosed epilepsy or a family history of seizures. It should also not be used by anyone with any metal device implanted in the head, neck or upper body, or by people with “an active implanted medical device such as a pacemaker or deep brain stimulator,” the FDA said.

The stimulator, manufactured by eNeura Therapeutics of Sunnyvale, Calif., is not meant to be used more than once every 24 hours, the FDA added. It has also not been tested to see if it is effective against other symptoms of migraine such as nausea or sensitivities to light or sound.

Green called that last point “disappointing,” and added that “the other concern is whether insurance carriers will make the product available [to patients].”

Source: Web md

Obesity tied to semi-frequent migraines

everyone should be aware that obesity is associated with an increased risk of episodic migraine and not wait until a patient has chronic migraine

Overweight and obese people are at higher-than-average risk of migraines, suggests a new study.

Researchers looking at so-called episodic migraines – headaches that occur less than every other day – found they were almost twice as common among obese people as among normal-weight adults.

“This suggests patients and doctors need to be aware that obesity is associated with an increased risk of episodic migraine and not wait until a patient has chronic migraine to address healthy lifestyle choices, such as diet and exercise, and to choose medications that impact weight with care,” lead researcher Dr. Lee Peterlin, from Johns Hopkins University School of Medicine in Baltimore, told Reuters Health in an email.

However, the researchers couldn’t be sure which came first – the extra weight or the headaches. And one migraine researcher not involved in the study said he would be cautious interpreting its findings.

“If this helps of course to make people believe they should lose weight, that’s great, but does it mean that reduction in weight will reduce migraine attacks, or treat migraines? That’s a question they haven’t addressed,” Dr. Tobias Kurth, of the French national research institute INSERM and the University of Bordeaux, said.

About 10 to 15 percent of people have episodic migraines, according to Peterlin.

Previous studies have linked obesity to chronic migraines, which by definition occur at least every other day. But there’s less evidence on whether weight also plays a role in less frequent migraines, researchers said.

To try to answer that question, Peterlin and her colleagues analyzed data on 3,862 people who participated in a national U.S. survey in the early 2000s, including 188 who reported having migraines an average of three or four times each month.

About 32 percent of people with episodic migraines were obese, based on their self-reported height and weight, compared to 26 percent of non-migraine sufferers.

After accounting for other differences between people with and without migraines, such as their age and smoking rates, the researchers found that being obese was linked to an 81 percent higher chance of having episodic migraines, they reported Wednesday in Neurology.

The obesity-migraine link was stronger among women and people under 50 years old but less clear for men and older adults, who have lower migraine rates in general.

Peterlin said there are a few possible explanations for the association, including that the same systems in the body that are activated during a migraine help regulate how much people eat. Also, people who get regular migraines may be less active because of the pain or take medications that influence weight gain, she said.

Kurth, who wasn’t involved in the new study, agreed lifestyle factors may play a role in both obesity and migraines. But he cautioned against drawing a direct link between weight and episodic migraines in the absence of more research.

“I’m just very careful, because I’m missing the big picture,” he told Reuters Health.

“If obesity would cause migraine, which is the suggestion of this study, we would expect to see an increase … in the prevalence of migraine, because we have such an epidemic of obesity in the United States,” he said. “And this is just not true.”

However, Peterlin said, rates of the two conditions wouldn’t necessarily be expected to go hand and hand on a larger scale – and that some studies have suggested episodic migraines are in fact becoming more common.

Source: fox news