Clot-Buster Enhanced by Ultrasound in Stroke Patients

The phase II pilot-study findings were published online before print October 24, 2013, in the American Heart Association journal Stroke. Lead author of the study, Andrew D. Barreto, MD, is an assistant professor of neurology in the Stroke Program at the University of Texas (UT) Health Medical School (Houston, USA).

The device, which uses UTHealth technology licensed to Cerevast Therapeutics, Inc. (Redmond, WA, USA), is positioned on the stroke patient’s head and delivers ultrasound to optimize the effectiveness of the clot-busting drug tissue plasminogen activator (tPA). Dissimilar to the standard hand-held ultrasound probe that is directed at a blood clot, the hands-free device used 18 separate probes and floods 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 Prof. Barreto, an attending physician at Mischer Neuroscience Institute (Houston, TX, USA). “This technology would have a significant impact on patients, families, and society if we could improve outcomes by another 10% or more by adding ultrasound to patients who’ve already received tPA.”

This is the first study of its kind, in which 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 presented and two hours exposure to 2-MHz pulsed wave transcranial ultrasound. Researchers reported that 13 (or 65%) patients either returned home or to rehabilitation 90 days after the combination treatment. Five of the 20 patients, after three months, had no disability from the stroke and one had slight disability.

Cerevast Therapeutics has recently initiated an 830-patient international, randomized efficacy study of the ultrasound application combined with the clot buster in ischemic stroke. Prof. Barreto is the North American lead 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).

Related Links:
University of Texas Health Medical School
Cerevast Therapeutics
Mischer Neuroscience Institute