CLOTBUST-hands free

Initial safety testing of a novel operator-independent ultrasound device in stroke-free volunteers

Kristian Barlinn, Andrew D. Barreto, April Sisson, David S. Liebeskind, Mark E. Schafer, John Alleman, Limin Zhao, Loren Shen, Luis F. Cava, Mohammad H. Rahbar, James C. Grotta, Andrei Alexandrov

Research output: Contribution to journalArticle

17 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)1641-1646
Number of pages6
JournalStroke
Volume44
Issue number6
DOIs
StatePublished - Jun 1 2013

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Brain Ischemia
Transducers
Volunteers
Thrombosis
Hand
Stroke
Safety
Equipment and Supplies
Blood-Brain Barrier
Neurologic Examination
Protective Devices
Phase III Clinical Trials
Phase II Clinical Trials
National Institutes of Health (U.S.)
Tissue Plasminogen Activator
United States Food and Drug Administration
Acoustics
Permeability
Ultrasonography

All Science Journal Classification (ASJC) codes

  • Clinical Neurology
  • Cardiology and Cardiovascular Medicine
  • Advanced and Specialized Nursing

Cite this

CLOTBUST-hands free : Initial safety testing of a novel operator-independent ultrasound device in stroke-free volunteers. / Barlinn, Kristian; Barreto, Andrew D.; Sisson, April; Liebeskind, David S.; Schafer, Mark E.; Alleman, John; Zhao, Limin; Shen, Loren; Cava, Luis F.; Rahbar, Mohammad H.; Grotta, James C.; Alexandrov, Andrei.

In: Stroke, Vol. 44, No. 6, 01.06.2013, p. 1641-1646.

Research output: Contribution to journalArticle

Barlinn, K, Barreto, AD, Sisson, A, Liebeskind, DS, Schafer, ME, Alleman, J, Zhao, L, Shen, L, Cava, LF, Rahbar, MH, Grotta, JC & Alexandrov, A 2013, 'CLOTBUST-hands free: Initial safety testing of a novel operator-independent ultrasound device in stroke-free volunteers', Stroke, vol. 44, no. 6, pp. 1641-1646. https://doi.org/10.1161/STROKEAHA.113.001122
Barlinn, Kristian ; Barreto, Andrew D. ; Sisson, April ; Liebeskind, David S. ; Schafer, Mark E. ; Alleman, John ; Zhao, Limin ; Shen, Loren ; Cava, Luis F. ; Rahbar, Mohammad H. ; Grotta, James C. ; Alexandrov, Andrei. / CLOTBUST-hands free : Initial safety testing of a novel operator-independent ultrasound device in stroke-free volunteers. In: Stroke. 2013 ; Vol. 44, No. 6. pp. 1641-1646.
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AU - Liebeskind, David S.

AU - Schafer, Mark E.

AU - Alleman, John

AU - Zhao, Limin

AU - Shen, Loren

AU - Cava, Luis F.

AU - Rahbar, Mohammad H.

AU - Grotta, James C.

AU - Alexandrov, Andrei

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