Explore CEFALY’s Clinical Studies

• What is CEFALY
• Our clinical studies
• Understanding CEFALY: Q&A

Learn more about CEFALY and delve into our clinical studies. Dive in with us as we unpack the results and answer frequently asked questions.

 

What is CEFALY?

CEFALY is a non-invasive migraine treatment that targets the primary pathway for migraine pain, the trigeminal nerve. 

CEFALY is ideal for people who:

• Find pharmaceutical treatments ineffective or hard to tolerate.
• Have limited access to outpatient treatment procedures.
• Prefer drug-free treatment alternatives.
• Have other medical conditions that interfere with pharmaceutical treatments.

The device has two modalities:

• ACUTE treatment: A 60-minute treatment you can use to relieve pain during a migraine attack.
• PREVENT treatment: This daily, 20-minute preventive program desensitizes the trigeminal nerve for long-term migraine reduction.

Try CEFALY Today

 

Our clinical studies

Multiple clinical studies have confirmed that CEFALY is a safe and effective alternative to medication. Clinical research has examined CEFALY’s effectiveness as both an acute migraine treatment for pain relief and a preventative migraine treatment to reduce the frequency of attacks. Here’s what a few of these studies have found. 

The Migraine Prevention with a Supraorbital Transcutaneous Stimulator (PREMICE) study

This study tested the effectiveness of the PREVENT treatment. Patients had a 20-minute preventive session every day for 90 days. We tracked the changes in their migraine days. In the end, we saw an average 30% reduction in their migraine days over that period. Patients who responded to treatment with CEFALY also decreased their acute medication intake by 74.6%. This study suggests that CEFALY is a viable alternative to pharmaceuticals.

The Acute Migraine Therapy with External Trigeminal Neurostimulation (ACME) study

In the ACME study, patients tried the treatment in a clinical setting. After an hour of ACUTE treatment, patients saw an average 59% reduction in migraine pain. Again, we noticed a significant decrease in the use of pain medication. 79% of CEFALY users experienced pain relief following an hour of treatment.

The TEAM (Trial of e-TNS for the Acute treatment of Migraine) study

Our largest clinical study to date involved patients using the CEFALY device at home, which proved they could use it safely without a doctor or clinician. Fully 26% of participants experienced complete pain freedom after using CEFALY’s ACUTE treatment for two hours. 56.4% experienced the resolution of their most bothersome symptom (MBS), and 42.5% of users reported resolution of all migraine symptoms.

 

Understanding CEFALY: Q&A

It’s natural to have questions when trying out a new migraine treatment. Here, we answer some questions from current and potential CEFALY users. Read through them for more information on CEFALY and how the device works:

Can I use PREVENT treatment even if I used ACUTE treatment on the same day?

Yes, you can. It’s best to keep up with your preventive treatments even if you need to use the acute option.

What ages can use CEFALY?

CEFALY is indicated for individuals aged 18-65. Please discuss the treatment with your doctor if you are under 18 or over 65.

What are the side effects?

While you may experience some side effects when using CEFALY, they have all shown to be reversible within 24 hours. The most common side effect our patients report is that the treatment has a sedative effect. When you use CEFALY, you may feel tired. Many people see this as a bonus, as it helps you relax while you have treatment. Avoid driving, operating heavy machinery or using the device in the shower. Try to lie down and relax for the duration of your treatment.

Other reported side effects include headache after a session and nausea. A small percentage of users report skin redness on the forehead. This is normal, and results from CEFALY activating the skin’s blood circulation. The redness usually goes away within 15 minutes.

If a rash develops, on the other hand, that may mean you have an allergy to the electrode gel. Stop using your CEFALY until the rash heals (an anti-inflammatory cream may help). Consider trying the hypoallergenic electrode to see if that helps.

What if I have sensitive skin?

If you’re worried about a skin reaction, we offer hypoallergenic electrodes for people with sensitive skin. We also have a special deal for anyone subscribing to our automatic delivery service. You can set it up for 30-, 60- or 90-day deliveries and receive 5% off and free shipping. This way you don’t have to remember to get new electrodes — we’ll take care of it and deliver whenever is most convenient. Start your subscription today.

Is CEFALY for every type of migraine?

CEFALY is indicated to be used for:

1. The acute treatment of migraine with or without aura in patients 18 years of age or older.
2. The preventative treatment of migraine in patients 18 years of age or older.

CEFALY’s effectiveness for treating specific types of migraine, such as hemiplegic or vestibular migraine, has not been studied. If you have a specialized type of migraine and want to use CEFALY, talk to your healthcare provider. 

What if CEFALY doesn’t work for me?

We offer a 90-day money-back guarantee. The PREVENT treatment is more effective the longer and more consistently you use it, so take some time to see if it works for you. If you don’t get the expected results, you can return CEFALY within 90 days of your delivery date, no questions asked.

What is CeCe?

The CeCe Migraine Management app is a simple and intuitive way to track your migraine. You can use it as a migraine diary and get insight into your personal trends and triggers. Pair CeCe with CEFALY Connected to select, control, and track your treatment sessions in real time; adjust your stimulation intensity; and log treatments and migraine attacks. Then, download your migraine reports to share with your doctor. 

Is it important to reach the highest electrical impulse level for effective treatment?

No, you don’t have to reach the highest intensity for the device to be effective. Start slow and start low. Stabilize the stimulation intensity at a level that’s noticeable but still comfortable. The treatment should never be painful. When you connect to CeCe, you can see your precise stimulation intensity and discover the best level for you.

Can I use CEFALY if I have Botox?

There is no contraindication for Botox. If you’re considering CEFALY and Botox, we recommend discussing it with your healthcare provider first. Those who use Botox injections for chronic migraine should wait 48-72 hours after injections. You can restart your CEFALY treatments after that period.

Where does CEFALY ship?

We ship in the U.S., Canada and Europe.

What if I feel uncomfortable using the device?

If you need guidance using CEFALY the first few times, book a free CEFALY Coach call. One of our expert coaches will answer your questions and help you get started.

Buy CEFALY today and experience these results firsthand

CEFALY is a clinically proven alternative to pharmaceutical migraine treatments. The clinical studies speak for themselves, delivering life-changing results to many with migraine. Try it yourself, risk-free. Shop online and improve your migraine journey today!