The Prima Trial – Percutaneous Closure of Patent Foramen Ovale In Migraine with Aura (A Randomized Prospective Study)

This is a clinical study designed to evaluate the effectiveness of PFO closure as a treatment for migraine. PFO closure is performed by placing an occlusion device into the PFO through a catheter in a catheter laboratory setting. The trial will measure and compare headache frequency and severity from those who receive PFO closure to those who do not. Approximately 144 patients will be enrolled in the PRIMA Trial at approximately 15 sites in the EU and Canada. Click here to visit NHS Heroes in the UK

Patent Foramen Ovale is a defect in the atrial septum, the wall between the two upper chambers of the heart. The foramen ovale is a flap or tunnel shaped hole in the atrial septum during fetal development that allows blood to travel through the heart without going to the lungs. This small flap-like opening normally closes shortly after birth as the pressure from the baby’s heart pushes the flap to the septal wall. If this opening does not close shortly after birth, a Patent Foramen Ovale (PFO) results.

A PFO occurs in about 1/4 of the population and can allow blood clots to move through blood vessels in the body. It is thought that small blood clots (micro embolisms) may trigger migraine attacks. Retrospective research has shown that some people who have had PFO closure for health reasons other than migraines have reported a reduction in frequency and severity of migraine attacks. For this reason, further knowledge on the relationship between PFO and migraine is being sought.

The Prima Trial is a prospective, randomized, multi-center, global clinical study designed to evaluate the possible connection between migraine headaches and PFO defects. Potential participants in the trial must meet a number of criteria to be considered for the trial, including:

18 to 65 years of age
First migraine headache experienced prior to age 50
Experienced migraine headaches with aura
Unresponsive to two or more preventive headache medications.
Participants who meet all criteria for the trial will either have closure of the PFO with the AMPLATZER® PFO Occluder and standard of care medical treatment, or standard of care medical treatment only.

Migraine sufferers who may meet the criteria, and are interested in participating in the trial can get more information at or through their headache specialist.

Oxygen as a Preventative Treatment
Can oxygen prevent occurrence of a migraine attack? The Headache Group at the National Hospital for Neurology and Neurosurgery in London is seeking volunteers for a project studying whether inhaled oxygen can prevent a migraine attack from being developed under conditions of increased energy demand. Neuro-imaging studies, drug trials and clinical expression are highly suggestive of abnormalities of energy metabolism in migraine sufferers.

In the current study, migraine attacks will be triggered using Nitroglycerine spray administered under the tongue. Apart from being useful in treating certain heart diseases, Nitroglycerine is a Nitric Oxide donor. Nitric Oxide is thought to increase the cells’ demand for oxygen for cellular respiration (the metabolic system of human brain cells) and this may mimic what happens in daily life when migraine sufferers develop attacks under conditions of increased energy demand, such as with stress. The Headache Group has previous experience with triggering migraine attacks using Nitroglycerine and has published several papers on this subject. Naturally, the volunteers will receive appropriate treatment as soon as symptoms indicate that a migraine attack is developing.

If treatment with inhaled Oxygen will prove to be successful in preventing migraine attacks from being induced by Nitroglycerine, the study will add weight to the theory that migraine implies an abnormality of the energy metabolism and it will shed light on understanding and managing migraine headache and many of the associated symptoms, which can be at least as disabling as the pain.

Taking part in this research includes a clinical review by one of the Research Registrars. If necessary, management recommendations will be made and if required follow up in the Clinic will be organised (in which case a referral from your GP or local neurologist will be needed). No referrals are required for participating in the study. Travel costs will be reimbursed for all the studies. Meals and soft drinks will be provided.

For more information regarding the study, please contact Dr Juana Marin on 07963 958319 or e-mail [email protected] or write to the Institute of Neurology at the Headache Group, Queen Square, London WC1N 3BG

Physiotherapy and Migraine
The University of Manchester is conducting a study on migraine led by Dr. Ian Davidson. The aim of the study is to find out if physiotherapy to the neck can reduce the frequency, duration and severity of migraine.

They are currently seeking volunteers for this study. Treatment will be based in one of 4 private physiotherapy clinics in and around the Manchester area and will be provided free of charge. You will be required to attend 5 sessions in total, each given once per week for 5 weeks. You would also be expected to complete a number of tests and questionnaires to allow the research team to assess the effect of the treatment.


Frequent use of painkillers complicating chronic migraine
The Headache Group and the National Hospital for Neurology and Neuroscience is looking for a limited number of migraineurs using opiate (codeine, tramadol, oxycodone, morphine)-containing medications on ten or more days a month for their headaches. With this project, the Group is aiming to understand opioid interactions with the mechanisms involved in migraine.


Migraine and PFO (North Midlands)A collaborative study between the North Midlands Headache Clinic and the University of Manchester vascular studies unit is looking at the possible relationship between migraine and patent foramen ovale (PFO). Individuals with migraine (with or without aura), aged 18-45 years will be interviewed, undergo scans and be asked to give blood. There is no planned intervention at this stage.

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