3-D Transcranial Ultrasound Analysis Study

Not Applicable

Completed

• Conditions: Cerebrovascular Accident; Intracranial Hypertension

• Registration Number: NCT00239525
• Lead Sponsor: Duke University

Brief Summary

The purpose of this study is to investigate real time 3-D ultrasound imaging of the brain for the diagnosis and evaluation of stroke.

Detailed Description

The objective of this proposal is to extend our previous advances to investigate real time 3-D ultrasound imaging of the brain for the diagnosis and evaluation of stroke. Over the last decade, with the availability of color flow Doppler combined with effective ultrasound contrast agents, a renaissance has occurred in transcranial sonography as a low cost, bedside method for evaluation and management of patients with cerebrovascular disease in spite of the image degrading properties of the skull. Our hypothesis is that we can combine new generations of 2D array transducers with ultrasound contrast agents and phase aberration correction to enable real time 3D ultrasound imaging and 3D color flow Doppler of the brain with a factor of 10 improvement in spatial resolution compared to conventional transcranial sonography for improved diagnosis and evaluation of stroke.

Study Timeline

• Study First Submitted: 2005-10-13
• Study First Submitted QC: 2005-10-13
• Study First Posted: 2005-10-17
• Study Start: 2006-05
• Primary Completion: 2007-04
• Study Completion: 2013-12
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-09
• Last Update Posted: 2014-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

Not provided

Exclusion Criteria

• persons <18 years old
• pregnant or nursing women
• history of neurological disease
• congenital heart defect
• severe liver dysfunction
• respiratory distress syndrome
• hypersensitivity or an allergic reaction to blood products.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Phase aberration correction of skull bone	6 months	This study will look to improve adaptive signal processing techniques for phase aberration correction of the skull while incorporating ultrasound contrast agent to increase signal to noise ratio in an ultrasound B-scan system with high speed RF data acquisition and 2-D arrays.In addition,we hope to develop adaptive transcranial real time 3D ultrasound and real time 3D color flow Doppler scanning of the brain incorporating ultrasound contrast agent to increase signal to noise ratio. A clinical evaluation of adaptive transcranial ultrasound imaging of the brain with phase aberration correction and ultrasound contrast agent will be conducted.

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States