New Study Finds CEFALY Has Very High Efficacy for Migraine Prevention

Results from a new clinical trial confirm the FDA-approved device has 81% efficacy among migraine sufferers

Aug 26, 2015, 09:00 ET from CEFALY Technology

NEW YORK, Aug. 26, 2015 /PRNewswire/ -- A new study finds that Cefaly, the first FDA-approved transcutaneous electrical nerve stimulation device specifically authorized for use prior to the onset of migraine pain, provides relief for 81% of migraine sufferers who use it.

The results of the clinical trial, published in The Journal of Headache and Pain, an international, peer-reviewed publication, found 24 migraine sufferers who frequently suffered episodic migraines without aura, experienced a very high efficacy when using the headband-like device, for 20-minutes per day, at least two-thirds of the required 60-day consecutive treatment period. The entire study was conducted from January 2013 to October 2014. The test group matched the category of patients in a 2,313 person study used to gain the approval of the Food and Drug Administration in March 2014. Those results were also published in The Journal of Headache and Pain, in December 2013.

"This is great confirmation on what we thought about the high efficacy of Cefaly," said Dr. Pierre Rigaux, chief executive officer of CEFALY Technology, the maker of the device. "We knew Cefaly to be very safe and with minimal side effects, but now we learn that it's not just the frequency of migraine days that's reduced for every four out of five patients, but the intensity of pain during a migraine attack is reduced as well."

The new study is the first to reveal the intensity of headache pain during a migraine attack is significantly reduced using the Cefaly device. Previous studies only focused on migraine prevention.

Dr. Antonio Russo and Professor Alessandro Tessitore, with the Headache Center, Department of Medical, Surgical, Neurological, Metabolic and Aging Sciences at the Second University of Naples, two of the authors that conducted the study, concluded that the technology used in Cefaly is "a first choice therapy in selected migraine populations due to the high level of efficacy and safety." They also find Cefaly to be an efficient option for the preventative treatment of migraine attacks -- particularly in patients who cannot, or choose not, to take daily medications.

While Cefaly does require a prescription, it is not a drug. It's the only device of its kind approved by the FDA and it uses tiny electrical impulses to stimulate the trigeminal nerve and reduce the frequency and intensity of migraines.

About CEFALY Technology 
CEFALY Technology is a Belgium-based company, with US offices based in Darien, Connecticut, specializing in electronics for medical applications. It has developed external cranial stimulation technology for applications in the field of neurology; in particular for treating migraines. For more information, visit Follow Cefaly on Twitter: @Cefaly and on Facebook:

Media Contact: Maria Coder