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Journal article
CLOTBUST-Hands Free Initial Safety Testing of a Novel Operator-Independent Ultrasound Device in Stroke-Free Volunteers
Stroke (1970), v 44(6), pp 1641-1646
01 Jun 2013
PMID: 23598523
Featured in Collection : UN Sustainable Development Goals @ Drexel
Abstract
Background and Purpose : We aimed to evaluate safety and tolerability of a novel operator-independent ultrasound device among stroke-free volunteers.
Methods : A headframe containing 18 ultrasound transducers (each operating at 2 MHz, pulsed-wave) was used to expose both temporal windows and the suboccipital window. The transmission characteristics were set to emulate the acoustic characteristics of the exposure levels in the Combined Lysis of Thrombus in Brain Ischemia using Transcranial Ultrasound and Systemic tPA (CLOTBUST) trial and to never exceed Food and Drug Administration mandated diagnostic ultrasound exposure limits. Volunteers underwent 2 hours of insonation with transducer activation one at a time. Safety was captured using serial neurological examinations and pre- and postinsonation MRI for detection of the blood brain barrier permeability.
Results : A total of 15 volunteers (40% men; 49 +/- 16 years; 27% black; all pre-exposure National Institutes of Health Stroke Scale scores 0) were enrolled. Five volunteers received pulsed-wave ultrasound via the best pair temporal transducers, 5 via sequential activation of the suboccipital transducers, and 5 via sequential activation of all bilateral temporal and suboccipital transducers. All subjects were safely insonated with no adverse effects as indicated by the neurological examinations during, immediately after the exposure, and at 24 hours, and no abnormality of the blood brain barrier was found on any of the MRIs.
Conclusions : Our novel device was well tolerated by stroke-free volunteers and did not cause any neurological dysfunction nor did it affect blood brain barrier integrity. The safety and efficacy of the device are now being tested in stroke patients receiving intravenous tissue-type plasminogen activator in phase II-III clinical trials.
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Details
- Title
- CLOTBUST-Hands Free Initial Safety Testing of a Novel Operator-Independent Ultrasound Device in Stroke-Free Volunteers
- Creators
- Kristian Barlinn - University of Alabama at BirminghamAndrew D. Barreto - The University of Texas Health Science Center at HoustonApril Sisson - University of Alabama at BirminghamDavid S. Liebeskind - University of California Los AngelesMark E. Schafer - Sonic Tech, Inc (United States, Lower Gwynedd)John Alleman - Cerevast Therapeutics, Inc. (United States, Redmond)Limin Zhao - University of Alabama at BirminghamLoren Shen - The University of Texas Health Science Center at HoustonLuis F. Cava - University of Alabama at BirminghamMohammad H. Rahbar - The University of Texas Health Science Center at HoustonJames C. Grotta - The University of Texas Health Science Center at HoustonAndrei V. Alexandrov (Corresponding Author) - University of Alabama at Birmingham
- Publication Details
- Stroke (1970), v 44(6), pp 1641-1646
- Publisher
- Lippincott Williams & Wilkins
- Number of pages
- 6
- Grant note
- National Institute of Neurological Disorders and Stroke (NINDS) Specialized Programs of Translational Research in Acute Stroke (SPOTRIAS) TL1RR024147 / NATIONAL CENTER FOR RESEARCH RESOURCES; United States Department of Health & Human Services; National Institutes of Health (NIH) - USA; NIH National Center for Research Resources (NCRR) P50NS044227 / National Institute of Neurological Disorders and Stroke; United States Department of Health & Human Services; National Institutes of Health (NIH) - USA; NIH National Institute of Neurological Disorders & Stroke (NINDS) UL1 RR024148; TL1 RR024147; KL2 RR024149 / National Institutes of Health (NIH) Clinical and Translational Award from the National Center for Research Resources NINDS SPOTRIAS Center for Clinical and Translational Sciences
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- School of Biomedical Engineering, Science, and Health Systems
- Web of Science ID
- WOS:000319465400033
- Scopus ID
- 2-s2.0-84880168554
- Other Identifier
- 991019176805704721
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- Collaboration types
- Domestic collaboration
- International collaboration
- Web of Science research areas
- Clinical Neurology
- Peripheral Vascular Disease