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The Cefaly device is indicated for the prophylactic treatment of episodic migraine in patients 18 years of age or older.

The Cefaly device is a transcutaneous electrical nerve stimulator (TENS) that is applied to the forehead (Fig. 1A) using a self-adhesive electrode positioned over the upper branches of the trigeminal nerve bilaterally (Fig. 1B). It is intended to stimulate the upper branches of the trigeminal nerve in order to reduce the frequency of migraine attacks. The Cefaly device consists of two distinct components: an electrical pulse generator (EPG) and a self-adhesive electrode (Fig. 1). The Cefaly EPG (Fig. 1A) is made of ABS plastic and consists of electrical circuits controlled by firmware and powered by two 1.5V batteries. The front of the Cefaly EPG has a single button that is used to turn the device on/off and also to adjust the intensity of the electrical stimulus during a treatment session. Visual and auditory indicators inform the user when the device is on vs. off and help them troubleshoot if it is not working properly (e.g., device indicates if batteries need replacing and if electrical connection between device and skin is unacceptable). The back of the Cefaly EPG has two metal blades that serve to electrically connect it to the Cefaly electrode. The Cefaly electrode (Fig. 1B) consists of a patient-contacting layer of gel, a layer of silvercoated carbon, and a layer of cotton. An ABS plastic pin in the middle of the electrode fits securely inside a receptacle in the back of the Cefaly EPG in order to maintain a secure electrical connection during a treatment session. The Cefaly electrode is meant to be used only with the Cefaly EPG, and vice versa. It can be reused a maximum of 20 times. A treatment session begins by attaching the Cefaly electrode to the middle of the forehead and attaching the Cefaly EPG to the electrode. When the on/off button is depressed, a pulsatile electrical stimulus is applied for 20 minutes. During the first 14 minutes, the intensity of the stimulus gradually increases until it reaches a maximum. At any time while the stimulus intensity is increasing, the user can press the button on the front of the device to select an intensity that is lower than the maximum, and it will remain constant at this lower value for the remainder of the treatment session. The device turns the stimulus off automatically after 20 minutes, or alternatively, the user can stop a treatment session by pressing the button twice or simply removing the device from their forehead.