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An ischemic stroke occurs when blood flow to the brain is blocked. When this happens, the hands-free ultrasound device is placed on the patient's head and delivers ultrasound to boost the effectiveness of the clot-busting medicine tPA (tissue plasminogen activator).
The new trial was funded by the U.S. National Institutes of Health and was published Oct. 24 in the journal Stroke.
"Our goal is to open up more arteries in the brain and help stroke patients recover," study author Dr. Andrew Barreto, an assistant professor of neurology in the Stroke Program at the University of Texas Health Science Center at Houston, said in a journal news release.
Unlike the traditional hand-held ultrasound device that's aimed at a blood clot, the hands-free version uses 18 separate probes and showers the deep areas of the brain where large blood clots cause severe strokes, the researchers said.
The new study included 12 men and eight women with an average age of 63. The patients had moderately severe ischemic strokes and received tPA within four and a half hours after the start of their stroke symptoms. They also received two hours of exposure to the hands-free ultrasound device.
Ninety days after the combined treatment, 65 percent of the patients had either returned home or were in post-stroke rehabilitation. A quarter of the patients had no stroke-related disability, and one patient had slight disability.
"This technology would have a significant impact on patients, families and society if we could improve outcomes by another 5 percent to 10 percent by adding ultrasound to patients who've already received tPA," Barreto said.
Barreto's team has launched an international study of the ultrasound approach combined with the clot buster, to be conducted in 830 ischemic stroke patients.
Two stroke experts not connected to the study said the device shows promise.
"The potential benefit of this technology is its simplicity and potential for widespread use within primary stroke centers that are the first to see the majority of ischemic stroke patients," said Dr. Jeffrey Katz, chief of vascular neurology at North Shore University Hospital in Manhasset, N.Y.
Katz said that if the data from trials continues to be positive, "we may finally have the first proven adjunct to intravenous tPA that has the potential for mass use because it does not rely on the availability of trained operators or expensive specialized facilities."
Dr. Sampson Davis, an emergency medicine physician at St. Michael's Medical Center in Newark, N.J., added: "Because I am the first doctor to encounter stroke patients, I'm excited about medical technology and thrilled to see such a timely study unfolding."
"Although more research steps are needed, including the aforementioned larger patient size, this project holds promise and is a step in the right direction in treating stroke," Davis said.
-- Robert Preidt
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SOURCES: Jeffrey Katz, M.D., chief of vascular neurology, North Shore University Hospital, Manhasset, N.Y.; Sampson Davis, M.D., emergency medicine physician, St. Michaels Medical Center, Newark, N.J.; Stroke, news release, Oct. 24, 2013