Type
Neurostimulation device
Developer
CEFALY Technology
Application
Acute and chronic migraine
Technology
Drug-free wearable
Development Status
Approved in the US by FDA
Please click here to read the main article for “ Tech-Enabled Migraine Relief: Wearables to the Rescue” based on extensive medical device research.
CEFALY is a drug-free migraine treatment that has been clinically proved to improve your quality of life and relieve migraine symptoms. This simple-to-use medical device, which requires no prescription, works to cure acute migraine attacks rapidly and prevent future episodes, potentially cutting your number of migraine days in half.
Cefaly is a non-drug migraine therapy option. The device adheres to a person’s brow and generates electrical impulses that reduce and prevent migraine symptoms. However, it may not be suitable for everyone, and persons who have special medical implants may need to reconsider utilizing the device.
CEFALY is indicated to be used for:
- The acute treatment of migraine with or without aura in patients 18 years of age or older
- The preventative treatment of episodic migraine with or without aura in patients 18 years of age or older.
CEFALY is ideal for people with migraine who:
- Don’t respond to pharmaceutical treatments or seek clinically proven effective alternatives to pharmaceuticals.
- Have prior medical conditions and are unable to take traditional pharmaceuticals.
- Have limited access to outpatient treatment procedures.
Do not use CEFALY if you:
- Have implanted metallic or electronic devices in the head.
- Are suffering from pain of unknown origin.
- Have a cardiac pacemaker or implanted or wearable defibrillator.
- Have recent brain or facial trauma (less than 3 months).
- Have a skin abrasion on the forehead in the area of application of the electrode.
- Have an allergy to acrylate.
- Have cutaneous hypersensitivity: +/- 5% of people present a hypersensitivity of the forehead skin and do not tolerate the sensation induced by CEFALY.
- Have trigeminal neuralgia.
- Have ophthalmic shingles.
How Does Cefaly Work?
Cefaly uses electrodes that adhere to the clean skin of the forehead. The electrodes are placed so that the narrowest part faces downward and the lower edge is located midway between the brows. Each electrode can be used between 15 and 20 times before it needs to be replaced.
The Cefaly device magnetically links to the electrodes and delivers precise micro-impulses to the upper branch of the trigeminal nerve, where migraines develop. Neurostimulation either cures headaches during an episode (Acute Setting) or helps to avoid future attacks (avoid Setting).
It is a medical device that is relaxing comfortable, and simple to use. Each session lasts 20 minutes and should be done in a relaxing, peaceful environment. Cefaly may cause drowsiness; therefore, do not drive or operate heavy machinery while taking it.
Once activated, you will feel a tingling sensation that intensifies over the course of 12 minutes. Once it reaches the maximum intensity that is comfortable for you, it will remain for the rest of the 20-minute session.
The first few times you use Cefaly, you will become accustomed to the sensation and can progress to higher intensity levels, resulting in more effective sessions. It is recommended to use Cefaly daily for the best results.
How do I Use Cefaly?
Step 1. Cleanse your skin
It is important to wash your skin before each CEFALY therapy session. This will help ensure the electrode is properly attached to your forehead.
- Wash between and above your brows with soap and water. After that, make sure to properly dry your skin.
- The use of makeup-removing products as a substitute for soap and water is NOT advised.
Step 2. Open the electrode
- Open the reusable electrode bag and peel the electrode from its plastic backing.
- To increase the life of the electrode, only handle it by the edges and with clean hands.
Step 3. Apply the electrode
- Using a mirror, position the electrode such that the curved area is between your brows and the wings are just above them.
- Run your fingertips over the electrode many times, making sure it is flat against your skin.
Step 4. Connect your device and begin treatment
- Hold the device so that the magnets on the back are exposed, then raise it up to your brow until it contacts with the electrode.
- To start the 60-minute ACUTE migraine relief program, press the button once. For the 20-minute PREVENT program, press it twice (with a little rest in between)
Frequently Asked Questions
Does Cefaly really work for migraines?
Approximately 59% of those who received the stimulation reported lower pain levels, compared to only 30% of those in the control group. In 2018, researchers investigated the efficacy of Cefaly3 and discovered that consistent use modifies the electrical pulses of the trigeminal nerve, lessening the intensity and frequency of migraines.
How much does Cefaly cost?
The device costs $299, plus $25 for a set of three reusable electrodes (each electrode is designed to be used 20 times). The device resembles a headband worn across the brow, with an electrode contacting the brow.
What is Cefaly migraine treatment?
CEFALY addresses the root issue by reducing pain impulses from the locations where migraine headaches begin. The CEFALY technology works directly on the migraine pathways to greatly alleviate pain and prevent migraines.
What are the side effects of Cefaly?
Sleepiness is a common side effect of using the Cefaly Dual, and only a small number of people reported headaches after using the preventive mode. Another uncommon adverse effect is forehead redness. Allergies to the skin.
Who should not use Cefaly?
Only for prescription use. A person who has a cardiac pacemaker or an implanted or wearable defibrillator cannot use the Cefaly device. A person who has a metallic or electrical device implanted in their head cannot utilize the Cefaly device.
Clinical Studies on Cefaly
The Trial of eTNS for the Acute Treatment of Migraine (TEAM) study found that the use of self-administered 2-hour eTNS therapy with CEFALY is a safe and effective therapeutic option, with or without the use of acute anti-migraine medications.
The TEAM study is the largest sham-controlled clinical trial examining the use of any e-TNS therapy for the treatment of migraine headaches.
26 % of CEFALY users reported pain freedom after 2 hours of treatment
57% of CEFALY users reported resolution of their most bothersome migraine symptom
43% of CEFALY users reported resolution of all migraine symptoms
Conclusion
Cefaly Dual Enhanced is a device that is worn on the forehead. It sends electrical impulses to the brain to lower the severity and frequency of migraine symptoms.
This device can be used when a migraine attack begins or every day to help prevent them. It can be purchased online on the company’s website.
If a person has a severe, sudden headache with new symptoms, they should seek fast and urgent medical attention.
References
- https://www.cefaly.com/how-it-works
- https://americanmigrainefoundation.org/resource-library/understanding-migrainecefaly-for-migraine-prevention/
- https://www.cefaly.com/product-reviews
- https://www.medicalnewstoday.com/articles/cefaly#who-is-cefaly-for
- https://www.cefaly.com/clinical-studies
