A hands-free ultrasound device combined with a clot-busting drug was safe for ischemic stroke patients in a phase II pilot study, reported in the American Heart Association journal Stroke.
The device is placed on the stroke patient's head and delivers ultrasound to enhance the effectiveness of the clot-busting drug tissue plasminogen activator (tPA).
Unlike the traditional hand-held ultrasound probe that's aimed at a blood clot, the hands-free device used 18 separate probes and showers the deep areas of the brain where large blood clots cause severe strokes.
"Our goal is to open up more arteries in the brain and help stroke patients recover," said Andrew D. Barreto, M.D., lead author of the study and assistant professor of neurology in the Stroke Program at the University of Texas Health Science Center at Houston. "This technology would have a significant impact on patients, families and society if we could improve outcomes by another 5-10 percent by adding ultrasound to patients who've already received tPA."
In the first-in-human study, 20 moderately severe ischemic stroke patients (12 men and 8 women, average age 63 years) received intravenous tPA up to 4.5 hours after symptoms occurred and two hours exposure to 2-MHz pulsed wave transcranial ultrasound.
Researchers reported that 13 (or 65 percent) patients either returned home or to rehabilitation 90 days after the combination treatment.
After three months, five of the 20 patients had no disability from the stroke and one had slight disability.
Researchers have launched an 830-patient international, randomized efficacy study of the ultrasound approach combined with the clot buster in ischemic stroke.
The study was conducted at the University of Texas Health Science Center at Houston and the University of Alabama-Birmingham.
Co-authors are Andrei Alexandrov, M.D.; Loren Shen, B.S.N.; April Sisson, R.N.; Andrew Bursaw, M.D.; Preeti Sahoti, M.D.; Hui Peng, Ph.D.; Manouchehr Ardjomand- Hessabi, M.D.; Renganayaki Pandurengan, Ph.D.; Mohammad Rahbar, Ph.D.; Kristian Barlinn, M.D.; Hari Indupuru, M.B.B.S.; Nicole Gonzalez, M.D.; Sean Savitz, M.D.; and James C. Grotta, M.D. Author disclosures are on the manuscript.
Dr. James C. Grotta was the principal investigator of the study which was funded by the National Institutes of Health.
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