Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00239525
Other study ID # Pro00008393
Secondary ID
Status Completed
Phase N/A
First received October 13, 2005
Last updated April 9, 2014
Start date May 2006
Est. completion date December 2013

Study information

Verified date April 2014
Source Duke University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date December 2013
Est. primary completion date April 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Intervention

Device:
3-D ultrasound scanner
The availability of color flow Doppler combined with effective ultrasound contrast agents in transcranial sonography serves 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.
Drug:
Perflutren Protein-Type A Microspheres for injection
Activated DEFINITY® (Perflutren Lipid Microsphere) Injectable Suspension is indicated for use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border.Bolus: The recommended dose for activated DEFINITY® is 10 microliters (µL)/kg of the activated product by intravenous bolus injection within 30-60 seconds, followed by a 10 mL saline flush. If necessary, a second 10 microliters (µL)/kg dose followed by a second 10 mL saline flush may be administered 30 minutes after the first injection to prolong contrast enhancement. Infusion: The recommended dose for activated DEFINITY® is via an IV infusion of 1.3 mL added to 50 mL of preservative-free saline. The rate of infusion should be initiated at 4.0 mL/minute, but titrated as necessary to achieve optimal image enhancement, not to exceed 10 mL/minute.

Locations

Country Name City State
United States Duke University Medical Center Durham North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Duke University

Country where clinical trial is conducted

United States, 

References & Publications (3)

Ivancevich NM, Pinton GF, Nicoletto HA, Bennett E, Laskowitz DT, Smith SW. Real-time 3-D contrast-enhanced transcranial ultrasound and aberration correction. Ultrasound Med Biol. 2008 Sep;34(9):1387-95. doi: 10.1016/j.ultrasmedbio.2008.01.015. Epub 2008 A — View Citation

Lindsey BD, Light ED, Nicoletto HA, Bennett ER, Laskowitz DT, Smith SW. The ultrasound brain helmet: new transducers and volume registration for in vivo simultaneous multi-transducer 3-D transcranial imaging. IEEE Trans Ultrason Ferroelectr Freq Control. — View Citation

Smith SW, Ivancevich NM, Lindsey BD, Whitman J, Light E, Fronheiser M, Nicoletto HA, Laskowitz DT. The ultrasound brain helmet: feasibility study of multiple simultaneous 3D scans of cerebral vasculature. Ultrasound Med Biol. 2009 Feb;35(2):329-38. doi: 1 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Phase aberration correction of skull bone 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. 6 months No
See also
  Status Clinical Trial Phase
Completed NCT05477238 - Oxygen Consumption in Post-stroke Patients During Various Walking Activities Compared to Healthy Controls N/A
Completed NCT00046293 - ReoPro and Retavase to Treat Acute Stroke Phase 2
Completed NCT04584645 - A Digital Flu Intervention for People With Cardiovascular Conditions N/A
Completed NCT01116544 - Treatment of Chronic Stroke With AMES + EMG Biofeedback N/A
Withdrawn NCT04991038 - Clinical Investigation to Compare Safety and Efficacy of DAISE and Stent Retrievers for Thrombectomy In Acute Ischemic Stroke Patients N/A
Active, not recruiting NCT02563886 - Electrically Assisted Movement Therapy N/A
Recruiting NCT02446730 - Efficacy and Safety of BiomatrixTM Stent and 5mg-Maintenance Dose of Prasugrel in Patients With Acute Coronary Syndrome Phase 4
Completed NCT02141932 - Pocket-size Cardiovascular Ultrasound in Stroke N/A
Completed NCT01915368 - Determining Optimal Post-Stroke Exercise (DOSE) N/A
Recruiting NCT02557737 - Botulinim Toxin Type A Injections by Different Guidance in Stroke Patients With Spasticity on Upper Extremities Phase 3
Recruiting NCT01769326 - Influence of Timing on Motor Learning N/A
Terminated NCT01705353 - The Role of HMGB-1 in Chronic Stroke N/A
Completed NCT01423201 - Transient Ischemic Attack (TIA) Triage and Evaluation of Stroke Risk
Completed NCT01656876 - The Effects of Mirror Therapy on Upper Extremity in Stroke Patients N/A
Completed NCT01182818 - Fabry and Stroke Epidemiological Protocol (FASEP): Risk Factors In Ischemic Stroke Patients With Fabry Disease N/A
Completed NCT00542256 - tDCS and Physical Therapy in Stroke N/A
Withdrawn NCT00573092 - Analyzing Gene Regions That May Interact With the Effectiveness of High Blood Pressure Drugs N/A
Completed NCT00377689 - Evaluation of an Intervention Program Targeted at Improving Balance and Functional Skills After Stroke Phase 2
Recruiting NCT00166751 - Sonographic Assessment of Laryngeal Elevation N/A
Completed NCT00125619 - Internally Versus Externally Guided Body Weight-Supported Treadmill Training (BWSTT) for Locomotor Recovery Post-stroke N/A