The US FDA has provided its initial acceptance for the marketing of a device for protecting against migraine headaches. The government agency states that the product, it is a kind of headband that offers a nerve-stimulating very low electrical current may provide relief to sufferers who are unable to tolerate present migraine medicines.
“This is also the initial transcutaneous electrical nerve stimulation gadget particularly approved for use before the onset of pain,” they informed the media.
The Cefaly device is a little, battery-powered plastic headband that is put on around the forehead. The product provides a lower electric current via the skin and may lead to a massaging feeling. The current influences the trigeminal nerve, which has been connected with migraine headaches.
The gadget, which is produced by STX-Med and accessible on prescription for individuals who are 18 and over, As per FDA this devise should be used daily once for 20 minutes.
With respect to the NIH, migraine headaches impact around 10 percent of individuals globally and are more frequent in females than males. The unbearable pain, which can continue from 4 up to 72 hrs, is experienced as intense throbbing in one portion of the head and is frequently associated by nausea, vomiting and sensitivity to light and sound.
FDA’s director of the Office of Device Evaluation, Christy Foreman states that:
“Cefaly offers a choice to drugs for migraine protection. This may assist sufferers who are unable to tolerate present migraine drugs for protecting against migraines or dealing with attacks.”
The FDA analyzed the research performed in Belgium, including 67 individuals of who were getting a minimum of two migraine problems a month and who stopped taking migraine drugs for the 3 months leading up to the begin of the trial.
The outcomes revealed that in comparison with sufferers using a dummy device, all those using Cefaly reported considerably less days per month with migraine and using fewer drugs. However, this device did not entirely avoid migraine strikes and did not decrease their intensity when they took place.
The US FDA also analyzed a sufferer fulfilment survey of 2,313 Cefaly people in France and Belgium that identified 53% were happy with the therapy and would buy it for even more use.
No severe undesirable effects were claimed by people in both studies. The very general problems that occurred in the user survey involved not liking the feeling of the therapy, not seeking to keep on using it, and feeling sleepy while in therapy and having a headache later on.