Approximately 10-15% of all Europeans suffer from migraines. Recent research suggests, among other things, a link between migraines and a common heart defect, a patent foramen ovale (PFO, "oval hole"). A PFO is a small opening between the upper chambers of the heart, which occurs in about 25% of the population. Blood flowing through this opening bypasses the filtration system of the lungs.
Studies have shown that people who suffer from severe migraines are more likely to have a patent foramen ovale (PFO). Therefore, it is suspected that migraine attacks are triggered by small blood clots that reach the brain along with unfiltered blood passing through the PFO. In certain cases, these blood clots can disrupt brain metabolism and cause migraine attacks.
The PRIMA study on patent foramen ovale and migraine
The current study on migraine is examining patients in whom this possible connection between their headaches and the PFO is to be clarified.
The Kiel Pain Clinic is one of the international testing centers where neurologists and cardiologists are investigating this connection.
What is the PRIMA study?
This clinical study helps determine whether a common heart defect, patent foramen ovale (PFO), contributes to migraine attacks.
The PRIMA study is a randomized trial. This means that participants have a 50:50 chance of receiving PFO closure and the corresponding treatment, or of receiving treatment according to the current standard without PFO closure.
The minimally invasive procedure takes about an hour and is performed by specialized cardiologists.
How is the PRIMA study conducted?
Participants are randomly assigned to one of two groups. One group receives the PFO closure and is treated according to current standards. The second group does not receive the closure but is treated according to current standards.
Study participants will receive free care as part of the study. Specialized physicians will monitor both patient groups throughout the study period. The results will be recorded and compared for both groups. The study has been reported to the relevant authorities.
Who can participate?
To participate in the PRIMA study, the following criteria must be met:
- Ages between 18 and 65, whereby the onset of migraine attacks must have occurred before the age of 50
- Diagnosis of migraine with aura
- Unsuccessful treatment with at least two generally accepted preventive medications
Even if you meet the above criteria, your further medical history and other factors will be taken into account to determine whether you are eligible for the study.
Participation in the study is free of charge.
How do I get included in the PRIMA study?
If you would like more information about the PRIMA study, please contact our registration office:
- Tel.: 0431-20099400.
A series of questions will be answered to determine if you meet the basic criteria. If so, an appointment for a personal examination will be scheduled. Before participating in the study, participants will receive an informed consent form, which they must read and which contains further information about the therapy within the study and what to expect. The study design will be explained in detail, and participants will have the opportunity to ask questions.
The initial tests for inclusion in the study include:
- the recording of the medical history,
- a headache diary kept over 3 months,
- completing the questionnaire on quality of life,
- the Beck Depression Inventory (BDI),
- completing the questionnaire to assess your functional impairment due to migraine (MIDAS questionnaire),
- clinical neurological examinations,
- Routine blood tests, ECG and TCD (transcranial Doppler ultrasound) or TTE (transthoracic echo) for right-to-left shunt.
What happens after I am enrolled in the study?
Patients are asked to keep a headache diary and receive neurological monitoring for one year. Patients undergoing PFO closure are also monitored by a cardiologist during this time and examined annually thereafter.
You can find more information in the information flyer .
Source: http://primatrial.com/
Hello, I'm a 58-year-old male. Since I was 15, so for several decades now, I've regularly suffered from migraines with aura (flashes of light, visual disturbances, and headaches). I get them about 6-7 times a year, without interruption. Two years ago, I had a stroke. In connection with this, an oval foramen was discovered, which I knew absolutely nothing about! I had it closed at the Aschaffenburg Hospital and haven't had an attack for two years now. Of course, I hope it stays that way. I know that the research on this is inconclusive. Personally, I strongly suspect there might be a connection. Since I searched extensively for other people's experiences back then, I decided to share my own.
I had a PFO occluder implanted in 2021 due to two strokes. Before that, I had a migraine attack almost every month, preceded by aura. Since the occluder was implanted, I haven't had a single migraine attack.
Hello,
My name is Carolin, I'm 34, and I've had migraines with aura for about 15 years. Previously, I experienced severe headaches and nausea after a visual aura (flashes of light) in my left eye, but now it's mostly just the aura without a headache. For some time now, I
've also been experiencing speech and sensory disturbances. @Gaby: Ten years ago, due to another illness that required surgery, I was diagnosed with a patent foramen ovale (PFO).
Were you referred by your neurologist for PFO closure? I've read about this connection before and am considering pursuing it further. The auras are sometimes very debilitating and occasionally occur every four weeks.
Hello, my name is Roger Widmer.
I've had migraine attacks with aura since childhood. In my early fifties, these attacks became so severe
that I could barely hold down a regular job. I contacted a clinic in Zurich
where I participated in a trial program with several new medications. Relpax helped me the most during a migraine attack, but there was a problem: with 12 to 15 attacks a month, it's easy to become dependent on these medications. As "chance," I suddenly developed a thrombosis in my left leg, which led to more thorough examinations. In addition to a blood disorder, they discovered a patent foramen ovale (PFO), and it was determined that I must have already had several very small embolisms.
On June 30, 2010, I had a device implanted at Inselspital in Bern.
Since that day, my condition has improved, and I think it will continue to get better. When I have a headache, a regular headache tablet is usually enough, or sometimes nothing at all!
Best regards, Roger Widmer
Hello,
my name is Melina, I'm 38 years old. I've had migraines since I was a small child. The older I got, and during my pregnancy, my attacks became more and more severe. First, I experienced visual disturbances, then light sensitivity, nausea, and depending on which side of the brain the attack was on, I also experienced paralysis. I tried every medication, but nothing helped. The attacks became more frequent due to stress at work. One day, I was at work when I noticed a headache coming on. I took a pill, and the strange thing was, after three minutes, it was gone. Weird, I thought. I went to my break, had a coffee, and then it happened: I heard my colleagues talking, but it was like watching a movie. I got such a severe headache that I thought my eye was going to pop out. Nausea and vomiting followed. My boss came over and immediately noticed something was wrong. I was taken to the hospital right away and had to undergo some tests. The doctor came, and I asked if I could go home. He said, "No, Ms. Kaiser, you'll be admitted to the stroke intensive care unit immediately." That's when it happened. At 34, I had a stroke :-( After a few tests, including a heart examination, they told me, "Ms. Kaiser, you have a PFO." And what did I get? A hole: a blood clot passed through it and triggered the stroke. After three months, it was closed, and since then, I've been doing incredibly well. Not a single migraine attack in four years! That's my story, and it really happened.
Hello,
I had a neuro-parathyroid device implanted in October 2010 (St. Katharinen Hospital, Frankfurt) and haven't had a migraine with aura since. Before, I had an aura about 3-6 times a year, accompanied by visual and speech disturbances. Unfortunately, my "normal" migraines didn't change after the procedure. I had hoped that they would also improve or disappear completely. But the aura is completely gone – that's something, isn't it? :-) Anyone interested can contact me! I know that most migraine patients with aura have never even heard of this, and I find that unbelievable :-( Doctors don't inform patients about it either; you have to find everything out for yourself. Best regards, Gaby Zettl