Researchers of the heart and headaches at Thomas Jefferson University Hospital are combining efforts to determine if a common heart defect may be the cause of some forms of migraine headaches.

Investigators from the Jefferson Heart Institute and the Jefferson Headache Center are enrolling participants in a blinded study to determine if closing a Patent Foramen Ovale (PFO), a small hole or flap that can allow blood to flow between the right and left sides of the heart, can stop migraines. In newborns, the PFO closes at or shortly after birth, but in 20 percent of adults the gap remains open to some degree.

More than 28 million Americans suffer from migraine headaches. Debilitating migraine headaches cause major disruption in individual's lives and cost billions of dollars in lost work, school and medical treatment each year. More than one quarter of the people who struggle with migraines have the heart defect.

Most people who have a PFO are never screened for it because doctors rarely suspect it of causing health problems but new evidence suggests that individuals with PFO are more susceptible to migraine. This susceptibility is believed to be due to the passage of material from the right side of the heart to the left side of the heart via the PFO. Blood and material that travels through the PFO is not filtered or oxygenated and in this form may travel to the brain, which can trigger the changes in the blood vessels that underlies migraine.

"Strokes, for example are sometimes triggered when blood clots passing through the PFO travel to the brain," said one of the study's primary investigators, David Fischman, M.D., Co-Director of the Cardiac Catherization Laboratory at Thomas Jefferson University Hospital, and Associate Professor of Medicine, Jefferson Medical College of Thomas Jefferson University.

"Up until now cardiologists have told us that patients with migraine get better when they have their PFO closed for other reasons," said Stephen Silberstein, M.D., director of the Jefferson Headache Center, the study's other primary investigator.

"We need to be able to prove that closure of a PFO by itself will actually diminish migraines," said Dr. Silberstein, Professor of Neurology, Jefferson.

In this study, participants will be randomly assigned to one of two groups. One group will undergo a minimally-invasive procedure to close their PFO. An interventional cardiologist will insert a catheter into the heart and release a device which will form a seal around the PFO to prevent the incorrect blood flow. Typically, the procedure lasts one to two hours under local anesthesia.

The other group will not have their PFO closed but will undergo a procedure that only mimics the closure and will continue medical therapy for their migraines. But none of the participants will know to which group they have been assigned to. However, all participants will receive the same post-operative care and will leave the hospital within 24 hours.



To participate in the study, patients must:

* Have experienced six to 14 days of migraines per month

* Be between 18 and 55 years of age

* Be unable to control migraines with medications currently available

For more information about the migraine study, please visit jeffersonhospital/.

Contact: Jeff Baxt
Thomas Jefferson University