How CEFALY Works For Patients With Frequent Migraines
CEFALY offers one of the best safety/efficacy ratios on the market for acute and preventive relief from migraine headaches.
CEFALY is a Breakthrough in Neurostimulation For Acute Migraine Relief and Prevention
What does CEFALY do?
CEFALY treats migraine pain with neurostimulation in patients with or without migraine aura. Migraine attacks involve the Trigeminal nerve, which is the largest and most complex of the cranial nerves. The Trigeminal nerve has three branches. The top branch can be accessed under the skin of the forehead.
CEFALY devices are 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.
How does CEFALY relieve pain?
CEFALY is an External Trigeminal Nerve Stimulation device (e-TNS) that sends tiny electrical impulses through the electrode to stimulate the Trigeminal nerve, reducing pain signals.
What does CEFALY feel like?
CEFALY generates tiny electrical impulses very gradually. During the first two minutes, you may feel nothing or a slight tingling sensation under the electrode. The sensation or tingling feeling increases gradually and spreads to your forehead and the front part of your head. After about 14-minutes, the intensity stabilizes and remains constant until your treatment session is over.
Clinical Studies Demonstrate Efficacy and Safety of CEFALY
Acute migraine treatment study
The CEFALY ACUTE program blocks pain and provides relief during attacks. After a one-hour ACUTE session: 59% of participants in our clinical study had a significant decrease in their migraine pain. This relief continued up to 24 hours.Read the study
Migraine prevention treatment study
Within three months of daily 20-minute PREVENT sessions with CEFALY, patients experienced a significant reduction in the number of migraine days.Read the study
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.
- If you are suffering from pain of unknown origin.
- If 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.