But until recently, neurologists had relatively few tools to help migraine patients. The treatment landscape has changed dramatically in recent years, says Alexander Feoktistov, a neurologist at the Synergy Integrative Headache Center in Chicago. “I have been in this field of headache medicine for probably over 20 years now, and I have never been more excited to work in this field than in recent years,” he said. declared.
Most recent article from a two-part interview with Dr Feoktistov discusses both drug treatments and medical devices for migraines, which affect approximately one billion people worldwide.
How has the migraine treatment landscape changed in recent years?
Feoktistov: This is unheard of. It’s like a small revolution in headache medicine over the past three years.
So the first CGRP monoclonal antibody, which was erenumab-aooe, came out in May 2018. And since that time we have had three more CGRP monoclonal antibodies. We had two gepants as acute treatments. We had a 5-HT1F receptor agonist known as Lasmiditan. And now one of these gepants, last week, has been approved for prophylactic use.
It’s amazing, but we have never seen this type of development of new drugs specifically developed for the treatment of migraine.
If you think about it, migraine is a pretty old condition. Hippocrates described migraines in his papers in great detail.
We’re talking about thousands of years of migraine history, but 2018 was the first year we had a drug specifically developed for migraines. Before the first CGRP monoclonal antibody, everything we used to treat migraine had been developed to treat something else, whether it was a seizure disorder, high blood pressure, or depression. We kind of borrowed these drugs from other areas. But CGRP is the first class of drugs dedicated to migraine alone.
The landscape changes.
What about the migraine device landscape?
Feoktistov: We also have this relatively new area of headache medicine called non-invasive neuromodulation which has also evolved quite intensely over the past few years.
We now have four devices approved by the FDA for the treatment of migraine acutely or prophylactically. These are the non-invasive nerve stimulators that use different mechanisms of action. They all work very differently showing promising results in that they provide our patients with non-pharmacological / non-medicinal options for treating headaches.
The most commonly used treatment now is called Cefaly, which is a brand name. It is a supraorbital / supratrochlear nerve stimulator. It is a relatively small device that a patient puts on their forehead between their eyebrows. Patients place a sticky electrode on the skin and then attach the device to it. After pressing a button, it electrically stimulates the supraorbital and supratrochlear nerves that innervate the forehead. These are the main sensory nerves of the trigeminal nerve, the main sensory nerve in the head and face. It is the nerve that is actively involved and activated during the migraine attack. The patients therefore apply the stimulation. And depending on the type of stimulation and the duration, it could be used prophylactically or acutely. Thus, acutely, a patient would apply stimulation for an hour with the onset of migraine. As a prophylactic, a patient would apply 20 minutes of stimulation each day, whether or not they had a headache.
This stimulation can cause the sensation of pins and needles in the forehead. This is something that patients will have to get used to. But it was cleared by the FDA many years ago, and in November 2020 it went over the counter. It no longer requires a prescription.
The second device that we use extensively with a lot of research behind it is a non-invasive vagus nerve stimulation device. The brand name is GammaCore Sapphire. This device is a portable device that patients hold in their hands. They apply stimulation to the side of their neck just below the jawbone. They apply exclusive stimulation to the vagus nerve fibers located next to the carotid artery.
Once the patient finds the vagus nerve, they apply this device to that area. They continue stimulation for only a few minutes with the onset of migraines or cluster headaches.
Patients can then use the stimulation regularly as well as for prophylactic purposes for migraines or cluster headaches. It has been approved by the FDA for use in the treatment of migraine and cluster headaches – both acutely and prophylactically.
In February of this year, he received an extended indication to also treat migraine in adolescents. And its mechanism of action is sophisticated. Several human clinical trials have been conducted, placebo controlled and randomized. They found GammaCore to be very effective and very well tolerated by patients. Its mechanism of action is unique. It changes certain levels of neurotransmitters. It has an impact on what is called cortically-spreading depression, which is a neurophysiological phenomenon involved in the development of the migraine aura. It is not painful stimulation. Patients feel a little tingling.
Finally, the other device with which we have had great success is called Nerivio. This device is made in Israel. This is an example of remote or conditioned pain modulation. It’s almost like a cuff applied above the elbow and below the shoulder. This device is wirelessly connected to a smartphone, then patients turn on the device using the smartphone app to start stimulation. By continuing the stimulation for approximately 45 minutes, patients can regulate the intensity, which should be quite intense. It shouldn’t be painful, but it should be very noticeable. Patients use it for about 45 minutes. This device is approved only as an acute treatment. Patients use it at the onset of a migraine attack. It’s supposed to abort the migraine attack. Studies have examined overall patient satisfaction when patients use Nerivio stimulation instead of standard oral drug therapy for migraine. Patients were frequently more satisfied with electronic stimulation than oral tablets.
There are a few reports from neurologists having a high prevalence of migraine headaches. A 2018 study in Brain behavior reported that between 27.6% and 48.6% of neurologists suffer from migraines. What is your opinion on this?
Feoktistov: If a neurologist is familiar with migraines, it is very difficult to misdiagnose. They would literally feel it and know what is going on. Sometimes patients cannot verbalize or describe some of their symptoms. Certainly, if a neurologist has a migraine attack and knows what a migraine attack looks like, it’s probably much easier to diagnose.
How often do you see patients whose migraines do not respond to treatment?
Feoktistov: It’s a common theme, unfortunately. Migraine may present differently in some patients. They sometimes present with different clinical symptoms. In some patients, nausea is very common. And in other patients, nausea is minimal or nonexistent. In some patients, migraine develops very quickly. It takes several hours for the migraine to start from zero and progress to a more severe stage in other patients. It can take half the day for some patients.
All of these factors, along with the patient’s susceptibility and tolerance to drugs, influence the overall effectiveness of treatment. Maybe 50% of the time you have to go back and see the patient again and adjust the medication or change it to something else. I wouldn’t say that we expect this, but it is something that we come across very frequently.
In addition, migraine is a very multifactorial disease. There are many different factors and even pathophysiological mechanisms that might be involved in some patients and, therefore, their responses might be different.
We know that this chemical called calcitonin gene-linked peptide (CGRP) has been studied and aggressively investigated for about 20 years. We now have several drugs targeting CGRP. But as important as it is, it may not be as important in all patients with migraine. There could be other mechanisms involved in some patients. It may require different treatment or re-treatment. So, yes, we frequently see patients needing to adjust their medications or even try something completely different, just looking at different regimens.