By Alec Mian, PhD, CEO, Curelator Inc. and Stephen Donoghue, PhD, VP Clinical Development, Curelator Inc.

Curelator Headache Population Map Displays Trigger & Protector Profiles for 150 Migraineurs

Curelator Headache is a transformational digital tool that allows individuals to track and discover the myriad factors that are associated with: a) increasing; b) decreasing; or, c) have no effect on their risk of migraine headaches. The Company collaborated with some of the world’s leading migraine neurologists to develop a comprehensive list of migraine triggers and symptoms, which were translated visually into a series of pictorial icons titled, Visual Migraine Language (VML). VML factors and symptoms must be tracked daily for 45 to 90 days before an individual’s maps can be generated based on the analysis of their data.

An example of an anonymous individual user’s results – delivered in the format of three sets of maps: Trigger, Protector and No Association Maps can be seen in Figure 2. Users also receive a Personal Summary Report to share with their physician. All of this information is designed to help users experiment with behavior modifications with the goal of reducing the number and severity of their migraine attacks. Migraineurs who are interested in the product for their own use can purchase it on the Curelator Headache website.

NHF/Curelator Headache Study: What do migraine triggers & protectors of 150 individuals look like?

In a recent collaboration with the NHF, Curelator Headache recruited migraineurs to test the clinical utility of its digital platform. The NHF with their commitment to furthering clinical understanding of migraine was a perfect partner to recruit migraineurs who were likely to be interested in using such a tool.

The goal was to scientifically determine some of the conditions and factors that may trigger or protect an individual from a migraine headache attack. After they entered 90 days of data, we generated personalized results for 150 individuals, including NHF members across the U.S. as well as some individuals in the UK. Surprisingly, these results illustrate that virtually every migraineur is different – as shown visually in the interactive Curelator Headache Population Trigger Map.

This discovery has immediate therapeutic implications. The foremost is that in migraine (and perhaps other chronic diseases with episodic attacks as well), one treatment may not fit all. Therefore, it may be difficult, if not impossible, to find a common therapy for everybody. This would certainly help explain the puzzle and frustration of limited effectiveness of current migraine therapeutics.

Triggers in some are protectors in others? Really?

In the study results shown in the NHF Population Trigger Map, Curelator Headache went one step further than simply looking for migraine triggers: it also looked for factors that were associated with decreasing an individual’s risk of an attack, so-called “protectors”. Doesn’t it become a singularly depressing mandate to find all the things in life we need to avoid? Why not look for positive things to embrace as well? But perhaps even more important, protectors revealed yet another level of individuality; triggers in some people appear to be protectors in others!

By looking at the individual associations of various factors we can see that many appear as triggers in some individuals and protectors in others. This is potentially a very important discovery because it leads directly to the following question. If certain factors can be triggers in some and protectors in others, could it be possible that some people are able to neutralize their triggers or possibly even turn them into protectors?

The best way to answer this question was to interview as many of the patients in the study as possible to understand the details of each individual’s condition. Fortunately we were able to interview several dozen people in the people in the study. Here is what we found.

Car Travel. In six patients, car travel was protective for their attacks and in seven it was a trigger. We interviewed several of the patients where car travel was a protector and all of these patients indicated that during car travel they were able to enjoy some solitude; in some cases the car was an opportunity to listen to their favorite music. Conversely, in people where car travel was a trigger, they seemed more aware of the traffic or the journey towards a stressful job. In other words, it didn’t seem to be the car, but the person’s state of mind in the car that was the determining factor.

Wine and Alcohol. Wine and alcohol was a less common trigger than expected and much more commonly found as a protector. In several interviews patients explained that when they drank alcohol it was usually a relaxing occasion: a glass of wine with their spouse, beer with friends. In a contrasting example, where sparkling wine was a trigger, the patient recognized that she drank sparkling wine at formal occasions such as weddings where the crowds of people became stressful. Similar to car travel, it was not the factor itself but the occasion associated with the factor that seemed critical.

Tyramine. Fully 18% of the people in the Curelator Headache NHF study had tyramine associated with their migraine attacks. More unexpected is the finding that in roughly half of these patients, tyramine turned up as a protector, not a trigger. Curiously, the appearance of tyramine as both trigger and protector in different individuals may indicate it has the potential to function in both capacities, depending on the person.

Stress. The population trigger map reveals that many patients show an association with stress and their attacks – in our study, 42%. What stands out, however, is that a small percentage of participants – only about 10% – show stress as a protector.  How could stress lower the risk of a migraine attack?

We interviewed one of these patients and he also was puzzled that stress turned up as a protector on his map. The first question we asked him was, “What did you do when you experienced stress?” Well, it turned out that he had a series of stress management techniques that included deep breathing, meditation and sitting quietly until he calmed himself down. Did this routine reverse the risk of a migraine attack?  It seems the answer is, “Yes, very effectively.”

Anger. Another of the participants had anger and anxiety as protectors. Upon reflection, he thought it was quite possible that he had developed a series of coping mechanisms that were so effective that they were associated with protecting him from attacks. Click “anger” on the Population Map and you will discover that four people have it as a protector while an additional 20 people have “anger” as a trigger. It is only through analysis of the individual patient that practical treatments such as these, which are discovered by the patients themselves, can be revealed.

Earlier we raised the question of whether it might be possible to transform a trigger into a protector and the profiles of more than a few of these interviewees suggest that they may have done exactly that. Dr. Paul R. Martin OAM, Professor of Clinical Psychology at Griffith and Monash University in Australia –  a leading migraine researcher – shared the following observation with us:

“Note that at least with some triggers, deviations in either direction have been suggested to cause headaches – for example, headaches allegedly can be precipitated by too little sleep but also too much sleep, and by stress but also relaxation. Perhaps one of the reasons that eating foods has been controversial as a headache trigger is because it is complicated to pin down – whether it is a good or bad thing to eat certain foods depends on circumstances – eating a certain ‘dose’ of chocolate is beneficial when blood sugar levels are low, but not when they are high. Certainly as a clinician I go down this pathway.”

A different kind of diary approach for managing migraine headaches

There is universal consensus that using electronic diaries is the first step in understanding the episodic nature of migraine and how to improve it. However, simple automated diaries only accelerate a manual process. They are not able to dismiss suspected triggers that, in fact, are not associated with attacks. Additionally, the ability to identify protectors, factors that are associated with decreasing the risk of an attack, has not been within reach of conventional diaries.

The Curelator Headache NHF study shows a different kind of diary approach can enable a technology that identifies both triggers and protectors and also dismisses non-relevant factors. This approach, when applied on an individual basis, reveals an extraordinary difference between individuals, which can help us untangle the complex interaction between triggers and protectors that governs attacks.

What’s next?

Since some factors can be triggers in some and protectors in others, the NHF/Curelator Headache study shows the importance of daily tracking and measuring possible triggers, protectors, prescription therapies and even alternative therapies on an individual basis. The next phase of the NHF/Curelator Headache study will be to expand the study to a larger population in collaboration with migraine neurologists who will receive referral coupons that allow their patients to enter the study cost-free. Participants must obtain a referral coupon through their doctor and be willing to be interviewed about their experience after they receive their results.

In parallel, Curelator Headache and NHF are planning to initiate a similar study with a pediatric population. The pediatric study will focus on factors more relevant to children and youth. Additional information, including how to register may be found on the Curelator Headache website (www.curelator.com).