By: Davidta Brown, Senior Staff Editor
A new therapeutic device has seemingly leapt from the pages of a science fiction novel and into the hands of migraine sufferers around the world. Worn over the forehead and sending electromagnetic stimulation directly into the supraorbital trigeminal nerves, the cranial nerve stimulator offered by Belgian biotechnology company Cefaly Technology is, clearly, turning heads.1 The nerve stimulator, referred to as Cefaly®, attaches to an adhesive electrode placed on the forehead of the headache sufferer.2 Through the electrode, the device generates micro-impulses that target the superior nerve endings of the trigeminal nerve.2,3 Cefaly® is a battery-operated device which, with the recommended 20 minutes of daily use, purports to reduce the frequency and intensity of migraine attacks at the minor expense of a mild tingling sensation.2,4
For Cefaly Technology, this particular cranial nerve stimulator is one of several devices under development. The company launched its Cefaly® project in 2005, with the first device of its kind presented in Bologna, Italy in 2006.5 The Cefaly® device was introduced to the French market in 2012, and received approval from the United States FDA in 2014.5 The model of the device approved in the US is somewhat less complex than the European model – the US model has one “standard program” of electromagnetic impulses, while the European model has three, is programmable, and has fully adjustable session duration and intensity.1 The European model of Cefaly® allows patients to increase the intensity of the impulses over time, which, in theory, should provide increasingly more effective and lasting relief from symptoms.2
There have been a few clinical studies evaluating the safety, efficacy, and adverse effects of Cefaly®, and, in general, all of the results have been similar. One trial tested the safety and efficacy of trigeminal neurostimulation with the transcutaneous stimulator in a double-blind, sham-controlled study.6 Sixty-seven patients, each of whom experienced at least two migraine attacks per month, were randomly assigned either a functional device or a “sham”, placebo device.6 Patients used Cefaly® as directed in at least one 20 minute session a day for three months, and the effects were evaluated as a reduction in the number of migraine days per month.6 The mean number of migraine days decreased significantly among individuals who received treatment, from 6.94 to 4.88 (p=0.023), but not among patients who had the placebo device; those patients experienced a reduction from 6.54 to 6.22 monthly migraine days (p=0.608).6 No adverse events were reported in either group during the course of this study, and the monthly intake of anti-migraine drugs also decreased significantly among the patients in the experimental group.6
Another larger safety study was conducted with 2,313 participants, in the hopes of screening for adverse effects in a larger population.7 In this study, participant selection was limited to individuals who were taking triptan drugs for migraine relief and who rented the Cefaly® device for a 40 day trial.7 After a testing period that lasted an average of 58.2 days, participants were assessed via phone interview to determine their satisfaction or lack of satisfaction with the device, as well as the presence of any side effects or technical difficulties.7 “Satisfied” study participants were those who wished to continue treatment with Cefaly® and were willing to purchase the device.7 Data collected at the end of the study showed that 54.4% of participants were satisfied with the results of the treatment. 4.3% of the individuals under study experienced one or more adverse events, but all of these were minor and fully reversible, such as local pain or irritation, sleepiness during treatment, or headache after using the device.7
The devices that were rented out to study participants each included software that monitored usage, and this data was collected and analyzed by researchers after the observation period.7 The data showed that of the 46.6% who were not satisfied with the effects of Cefaly®, 48.6% had not used the device for the recommended period of time, and 4.46% had never even turned it on.7 Taken together, all of these results led researchers to pronounce the transcutaneous neurostimulation provided by Cefaly® a “safe and well-tolerated treatment for migraine headaches”. 7 Furthermore, the results of these safety studies have piqued curiosity about the device’s possible use as a treatment for other disorders, including insomnia.4 In the end, time in the hands of the public will be the most important test of the device’s value, and will answer the question of whether Cefaly® is the solution that millions of migraine sufferers have been hoping for.
- Products. Cefaly Technology. http://www.cefalytechnology.com/en/products. Accessed June 11, 2014.
- How does it work? Cefaly. http://www.cefaly.us/en/how-it-works. Accessed June 11, 2014.
- Questions. Cefaly. http://www.cefaly.us/en/questions. Accessed June 11, 2014.
- Piquet M, Balestra C, Sava S, Schoenen J. Supraorbital transcutaneous neurostimulation has sedative effects in healthy subjects. BMC Neurol. 2011;11:135.
- Company. Cefaly Technology. http://www.cefalytechnology.com/en/company. Accessed June 11, 2014.
- Schoenen J, Vandersmissen B, Jeangette S, et al. Migraine prevention with a supraorbital transcutaneous stimulator [Abstract]. Neurology. 2013;80(8):697-704.
- Magis D, Sava S, Sasso d’Elia T, BaschiR, Schoenen J. Safety and patients’ satisfaction of transcutaneous Supraorbital Neurostimulation (tSNS) with the Cefaly® device in headache treatment: a survey of 2,313 headache sufferers in the general population. J Headache Pain. 2013;14:95.
[pubmed_related keyword1=”cefaly” keyword2=”migraine” keyword3=”device”]