Migraine Treatment and
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Frequently Asked Questions
CEFALY is the first FDA-cleared device of its kind for the treatment of migraine headaches. It is a comfortable, drug-free, approach to help relieve pain and decrease the number of migraine days. In technical terms, it is an external trigeminal nerve stimulator, which is a non-invasive device placed on the head to stimulate and desensitize the Trigeminal nerve.
Research identifies the Trigeminal nerve as a center for migraine pain and can be accessed under the skin of your forehead. The CEFALY device has been specifically designed to make contact with the nerve endings of this branch via an electrode positioned on the forehead between the eyebrows. Once an electrode has been placed, the device magnetically secures a connection and begins to send tiny electrical impulses through the top branch into the Trigeminal nerve.
A session with the ACUTE setting lasts one hour and is used during a migraine attack. The session can be repeated for another 60-minute session if necessary or if another migraine attack occurs. A session with the PREVENT setting lasts 20 minutes. It must be used daily and may be done at any time throughout the day, though an evening session is preferred.
The CEFALY device should not hurt and is safe. However, the sensations experienced while using the CEFALY device are novel to most people and can take some adjustment. To make treatment more enjoyable, we recommend you increase intensity in small increments of time, over the course of a few weeks. If you feel the intensity is too strong for you, simply press the button to stabilize the session.
If 10 seconds after you’ve selected your session, you wish to increase the intensity, you can press and hold the button to quickly ramp up the intensity to your desired strength. When you release the button, the intensity will stabilize and remain constant. Should you press and hold the button again, the intensity will increase again. The maximum intensity is reached after pressing and holding the button for 30 consecutive seconds.
Indications, Contraindications, Precautions & Warnings
CEFALY is FDA-cleared for
- The acute treatment of migraine with or without aura in patients 18 years of age or older.
- The prophylactic treatment of episodic migraine in patients 18 years of age or older.
Do Not Use CEFALY if
- You have an implanted metallic or electronic device in the head.
- You are suffering from pain of unknown origin.
- You have a cardiac pacemaker or implanted or wearable defibrillator.
Check with your doctor before using the CEFALY DUAL device if
- You are pregnant or may become pregnant.
- You suspect or know that you have heart problems.
- You have ever suffered a seizure.
- You have had a recent head injury.
CEFALY device and electrode are designed and intended for use on the forehead only.
- Do not apply to the neck.
- Do not apply to the chest.
Only apply stimulation to normal, intact, clean skin.
- Do not apply over open wounds.
- Do not apply over swollen, infected or inflamed areas.
- Do not apply over skin eruptions.
- Do not apply over, or close to, cancerous lesions or skin abnormalities that could be cancerous.
- Do not use in the presence of electronic monitoring equipment (e.g., cardiac monitors, electrocardiogram (ECG) alarms).
- Do not use with water. Such as, in the bath or shower.
- Do not use while sleeping.
- Do not use while driving, operating machinery or any activity that can put you at risk of injury.
- Some individuals may experience a minor allergic skin reaction to excipients in the electrode adhesives. Contact Cefaly if you experience any reactions.
- Migraines may indicate that you have a serious medical condition. Have any persistent pain checked by a qualified healthcare professional.