A new study finds that Cefaly, the first US Food and Drug Administration (FDA)-approved transcutaneous electrical nerve stimulation device specifically authorised 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, 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 FDA 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 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 is not just the frequency of migraine days that has 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.
Antonio Russo and Alessandro Tessitore, with the Headache Center, Department of Medical, Surgical, Neurological, Metabolic and Aging Sciences at the Second University of Naples, Italy, 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 is 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.
