Researchers from Neurology and
Cardiovascular Medicine at Beaumont
Hospital are recruiting
14 volunteers to study if patching a hole in one's heart reduces the number of
migraine headaches better than medication.
The hole in the heart, called a
patent foramen ovale, normally closes at or shortly after birth. When it
doesn't, blood leaks from the right side of the heart to the left side and then
travels to the brain, carrying chemicals with it that may cause migraines.
Normally, the blood travels from the right side of the heart to the lungs,
where those chemicals are removed, before it flows to the brain.
The study will use an experimental
device, the Amplatzer PFO Occluder, to patch the hole.
Participation in the research study
lasts up to five years. Volunteers must already have been diagnosed with
migraine headaches and may have been told they have the heart defect. They will
undergo several tests, including one to evaluate the rhythm and electrical
activity of the heart; another that uses ultrasound to assess blood flow in the
brain; and a third test that uses sound waves to create a picture of the heart.
Half of the volunteers will get the
patch and half will not. The device is inserted through a tube that is
introduced through an incision in the groin, then travels to the heart. All
participants will take blood thinning medication and possibly an antibiotic.
They will be asked to make at least nine follow-up visits to the study doctors.
They will not be allowed to change their migraine medication for one year after
The study sponsor will cover the
costs of the patch, the procedure to install it and all testing required.
For more information about this
study, please call study coordinator Cynthia Leathers, R.N., nurse manager of
Cardiovascular Research, at 248-898-5580.
"Previous research leads us to
believe that repairing the PFO (patent foramen ovale) will reduce not only the
frequency but also the severity of migraines," says George Hanzel, M.D., a
cardiologist who is co-leading the study at Beaumont with neurologist Jonathan Fellows,
Dr. Fellows says," If this
approach works, we will have one more option for patients plagued by these
debilitating headaches, freeing them from pain and improving their quality of
Beaumont is Michigan's, and one of
the nation's, most experienced providers of heart care, ranking 12th on the U.S.
News and World Report 2007 list of the "Top 50" hospitals for
heart and heart surgery. The Beaumont
is a comprehensive, state-of-the-art facility that's dedicated to the
prevention, diagnosis and treatment of heart problems. Beaumont's
Ministrelli Women's Heart Center is the first in Michigan devoted exclusively to the
prevention, diagnosis, treatment and research of heart disease in women.
The Neurology department at Beaumont treats all
neurological diseases, including stroke, Parkinson's disease, Alzheimers
disease, muscular dystrophy, multiple sclerosis and migraine, among others. In
addition, the hospital has a Myasthenia
Center; a Neurology
Clinic; a Neuromuscular Clinic for children; neuroradiology; and clinical
neurophysiology. Beaumont is included on the U.S. News and World Report
2007 list of the "Top 50" hospitals in the country for neurology and
neurosurgery, with Beaumont, Royal Oak ranking 35th and Beaumont, Troy ranking