HOUSTON - (Oct. 24, 2013) - A study led by researchers at The University of Texas Health Science Center at Houston (UTHealth) showed that a hands-free ultrasound device combined with a clot-busting drug was safe for ischemic stroke patients.
The results of the phase II pilot study were reported today in the American Heart Association journal Stroke. Lead author is Andrew D. Barreto, M.D., assistant professor of neurology in the Stroke Program at the UTHealth Medical School. Principal investigator is James C. Grotta, M.D., professor and chair of the Department of Neurology at the UTHealth Medical School, the Roy M. & Phyllis Gough Huffington Distinguished Chair and co-director of the Mischer Neuroscience Institute at Memorial Hermann-Texas Medical Center.
The device, which uses UTHealth technology licensed to Cerevast Therapeutics, Inc., 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 Barreto, an attending physician at Mischer Neuroscience Institute. "This technology would have a significant impact on patients, families and society if we could improve outcomes by another 10 percent or more by adding ultrasound to patients who've already received tPA."
In the first study of its kind, 20 moderately severe ischemic stroke patients (12 men and eight 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.
Cerevast Therapeutics has recently launched an 830-patient international, randomized efficacy study of the ultrasound approach combined with the clot buster in ischemic stroke. Barreto is the North American principal investigator for that Phase III study called Combined Lysis of Thrombus with Ultrasound and Systemic Tissue Plasminogen Activator (tPA) for Emergent Revascularization in Acute Ischemic Stroke (CLOTBUST-ER). Locally, patients will be recruited from Memorial Hermann-Texas Medical Center, Memorial Hermann Southwest Hospital and Baptist Beaumont Hospital.
The study was conducted at UTHealth and the University of Alabama-Birmingham with funding from the National Institutes of Health (NIH) including the National Institute of Neurological Disorders and Stroke (P50NS044227, 1K23NS02229-01, 1P50NS044277), an NIH training grant (T32NS07412) and the National Center for Research Resources (UL1RR024148).
UTHealth co-authors are Nicole Gonzales, M.D.; Sean I. Savitz, M.D.; Andrew Bursaw, M.D.; Preeti Sahota, M.D.; Renganayaki Pandurengan, Ph.D.; Mohammad Rahbar, Ph.D.; Loren Shen, B.S.N.; Manouchehr Ardjomand- Hessabi, M.D.; Hari Indupuru, M.B.B.S.; and Hui Peng, Ph.D. Other co-authors are Andrei Alexandrov, M.D.; April Sisson, R.N.; and Kristian Barlinn, M.D.