MedicalResearch.com: What are the main findings of the study?
Dr. Barreto: Applying a novel, operator-independent device used to produce ultrasound energy through the skull of stroke patients receiving IV-tPA (intravenous clot-busting medication that is the standard treatment for stroke patients) was safe – no signal of increased risk of symptomatic intracerebral hemorrhage (brain bleeding).
Rates of recanalization (clot dissolution) were consistent with prior work that suggest aiming transcranial Doppler ultrasound energy at the clot amplifies the clot-busting effect of tPA alone.
MedicalResearch.com: What should clinicians and patients take away from your report?
Dr. Barreto: Although more data is necessary, our results suggest that this new device might be substituted for an ultrasound expert at the bedside to provide skill in aiming the ultrasound energy at the clot causing strokes. Thus, if sonothrombolysis (term used to describe the clot-dissolving effect of ultrasound) is proven effective, this new device could be placed on the head of any stroke patient anywhere since it does not require a skilled technician or physician.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Dr. Barreto: The device needs more study and I am happy to report that the necessary (and pivotal) study is actually on-going. See the CLOTBUST-ER study (www.clinicaltrials.gov NCT01098981). This study is a large, double-blinded international study of 830 stroke patients randomized to receive tPA + 2-hours of ultrasound vs. tPA alone (sham ultrasound). Results of CLOTBUST-ER will hopefully confirm that not only does sonothrombolysis recanalize more brain arteries, but patients have improved outcomes (less disability) at 3-months.
From the Department of Neurology, Stroke Program (A.D.B., L.S., A.W.B., P.S., H.I., N.R.G., S.I.S., J.C.G.) and Center for Clinical and Translational Sciences (H.P., M.A.-H., R.P., M.H.R.), University of Texas Health Science Center at Houston, TX; Comprehensive Stroke Center, Department of Neurology, The University of Alabama at Birmingham (A.V.A., A.S.); and Department of Neurology, Dresden University Stroke Center, University of Technology Dresden, Dresden, Germany (K.B.)