Interview with Cefaly’s Global Medical Director

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I had the incredible opportunity to interview Dr. Mark Harman, the Global Medical Director at CEFALY.
Cefaly is a migraine treatment that treats and prevents migraine attacks with virtually no side effects. Crazy, right? To some, this may sound too good to be true, or a type of placebo treatment. However, Cefaly’s technology has been around for years, and its efficacy has been proven in several clinical trials. To learn more about their device, and if it’s an option for you, read the interview below with Dr. Mark Harman, the Global Medical Director at Cefaly. He works to ensure that the information Cefaly shares with the world are scientifically and medically sound.

 

What’s your role at CEFALY Technology?

My role at CEFALY Technology is the Global Medical Director. As such, I touch everything from Marketing to Research to information requests to customer service in the United States, Canada, Europe, Southeast Asia, Russia, and other countries around the world. I ensure that all the information we release and analyze is scientifically and medically sound.

What is the CEFALY DUAL device?

The CEFALY DUAL is a very novel migraine treatment known as neuromodulation. Traditionally treatments for migraines have all consisted of pharmaceuticals such as triptans, ibuprofen, or topiramate. When you take a pill, it must pass through your entire body, giving an increased chance of possible side effects. Neuromodulation, however, creates a targeted therapy to treat the area research has identified as the cause of a migraine, without the need to ingest medication.

Who is the CEFALY DUAL device recommended for?

CEFALY DUAL is indicated for the acute treatment of migraine with or without aura in individuals over the age of 18. It is also indicated for the preventative treatment of episodic migraines in persons over the age of 18. Our studies have shown CEFALY is effective and safe in these populations.

Is there anyone that should not use CEFALY?

There are three circumstances we do not recommend using a CEFALY device: If you have a metallic or electronic device implanted in your head, a pacemaker or implanted defibrillator, or if you have a pain of unknown origin. Aside from these three contexts, we believe CEFALY DUAL is a great, non-pharmacological treatment option for migraines. If you are diagnosed with migraines ask your healthcare provider if CEFALY could be a viable treatment option for you.

How do patients use the CEFALY DUAL?

First, we always recommend you wash your forehead with soap and water to remove the oil and dirt that accumulated on your face throughout the day since using the device requires applying a small electrode to the forehead. The better you wash and dry your face, the greater the adhesion and contact the electrode will have on your skin. The electrode and the CEFALY DUAL have flat-bottom areas with two wings that go out. You magnetically adhere the device onto an electrode applied to the center of your eyebrows. CEFALY DUAL then delivers a mild stimulation treatment through the electrode. You press the device button once to activate the acute treatment, and twice for the preventative treatment.

How does CEFALY work on a cellular level?

Research has found the nerve fibers targeted by the CEFALY DUAL play a strong role in migraine development and pain. We researched numerous specific frequencies and wavelengths until we found the frequency ranges for the specific nerve fibers involved in migraine attacks. CEFALY acts by modifying these nerves to behave more physiologically normal and, therefore, preventatively decrease the number of migraine attacks one has or acutely reduce active migraine pain.

To give you a very simplified analogy for how the preventative treatment setting works, imagine you were standing next to me, and I said, I am going to poke you over and over again. For the first few minutes, my pokes would be very irritating and you would definitely notice them. However, if the poking is not really painful, you would eventually stop noticing that I was poking you at all. This is because your brain stops treating the signals coming from those nerves as priority because it has other, more important stimuli to pay attention to. Therefore, those nerves become less sensitive in relaying that information. Migraine development and pain are similar to this in that the nerves responsible for telling your brain that it should feel migraine pain are extremely easy to excite at the slightest provocation. Think of them as a person with serious anger-management problems. The CEFALY device, however, targets these “sensitive” nerves and activates them enough to irritate them, but not trigger a headache. With compliant use of 20 minutes per day, these nerves eventually stop being so hypersensitive and one sees a smaller number of headaches per month.

The second treatment setting for the CEFALY DUAL is acute migraine treatment. The acute setting, which is used during migraine attacks, sends a much stronger signal that overwhelms or preoccupies the nerve fibers and reduces the number of pain signals getting to the brain’s pain centers. This stronger signal helps reduce or alleviate the headache pain one is experiencing.

We are often confused with Transcranial Magnetic Stimulation Devices. CEFALY treatments do not work on magnetism, but on neuromodulation through very mild electrical current. The magnets in the CEFALY DUAL are not strong enough to provide treatment, they are there only to allow the device to attach securely to and relay the treatment frequency through the electrode.

Are there any side effects of the CEFALY DUAL device?

There are minimal side effects of the CEFALY DUAL and those that can occur completely resolve when one stops use of the device. One side effect is not the result of CEFALY use, itself, but the electrode adhesive gel components. People with a known allergy to acrylate will experience an allergic reaction to the electrode adhesive gel. Most often this is seen as the development of a rash where the electrode is placed on the forehead. The rash should go away with care and cleaning. Cefaly also offers a hypoallergenic electrode for people known to have acrylate allergy or who possibly develop one.

Another common experience reported when using a CEFALY device is a mild sedative, zen-like feeling. Users often report feeling very relaxed when using the device and for some time after. As a result, many users report to us that they schedule their treatments before going to bed. Cefaly has not studied the effect of its use with sleep, however.

What would you tell a patient that is hesitant to use the CEFALY DUAL device?

CEFALY is a passion-driven biotech company. CEFALY’s research, development, and treatments focus on migraines only. We are not here to see how many different treatments for every disease we can market; We are here to help those suffering from migraines. Our CEO suffers from migraines and she treats them regularly with her CEFALY device. She and we know how awful and debilitating they can be. As a result, our mission is to make this treatment as accessible to as many migraine sufferers as possible.

For example, we offer multiple payment financing options including Affirm and PayPal Credit allowing you to pay over a period of months with financing as low as 0% APR. In addition, we have a 60-day money-back free trial, so you can try the product and see if it works for you, risk-free. Finally, we do not just want to sell you a device. We want to become partners with you in your journey: No matter your question or concern, the CEFALY Technology team is here to support the migraine community, always.

Could the CEFALY device be used to treat other neurological illnesses in the future?

We have found some additional applications and we’re just beginning preliminary and exploratory research around them. Unfortunately, I am not at liberty to speak about it at this time.

Success stories?

We’ve sold more than 350,000 devices worldwide and treated over 2 billion migraines. That is the difference we make, and if you’re curious to know what real users have to say, visit our Facebook page and the blog on our website.

To learn more about Cefaly visit their website: https://www.cefaly.com/

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