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Is a Heart Defect at the “Heart” of Migraine Headaches?
Jefferson researchers have initiated a blinded study to investigate a possible link between Patent Foramen Ovale and these often debilitating
headaches
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Do you qualify for this study?
To participate in this study, you 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
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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 individuals’
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 are not filtered or oxygenated and in this form may travel to the brain, which can trigger the changes
in the blood vessels that underlie migraine.
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Stephen D Silberstein, MD
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David Fischman, MD
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“For example, strokes are sometimes triggered when blood clots passing through the PFO travel to the brain,” said one of the
study’s primary investigators, David Fischman, MD, 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 headaches get better when they have their PFO closed
for other reasons,” said Stephen Silberstein, MD, 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, who
is also Professor of Neurology, Jefferson.
In this study, participants are being 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. 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
“Patients who participate in this study will get top-notch headache care,” notes Dr. Silberstein.
For more information
For more information about the migraine study, please call 1-800-JEFF-NOW or 215-955-2037, or visit www.jeffersonhospital.org.
