Study: SONAS Ultrasound for Detecting Stroke SONAS Ultrasound for Detecting Stroke
| Status: | Completed |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/28/2019 |
| Start Date: | April 19, 2018 |
| End Date: | January 20, 2019 |
SONAS Ultrasound Device for the Detection of Ischemic and Hemorrhagic Stroke
The purpose of this research study is to test a new medical device, called SONAS. The SONAS
device is a portable, battery-powered ultrasound device to detect strokes in the prehospital
environment, such as emergency vehicles (eg. ambulances, helicopters). To demonstrate the
safety of the device the goal is test it in a small number of healthy volunteers first.
The SONAS device will be used to detect changes in blood flow to the brain through
ultrasound, otherwise known as TransCranial Doppler (TCD). To date, the SONAS device has been
tested extensively in the laboratory, in animals and in human cadavers. The purpose of the
present study is to test the device for safety and efficacy in a small group of healthy
volunteers. This study will test the device on 10 healthy volunteers. Each volunteer will
have a physical examination, neurological examination, and brain MRI both before and after
the TCD test is performed. All of these study procedures will be performed on 1 visit,
lasting approximately 5 hours. The brain MRI's will be used to verify the effectiveness of
the SONAS device on detecting changes in blood flow to the brain.
device is a portable, battery-powered ultrasound device to detect strokes in the prehospital
environment, such as emergency vehicles (eg. ambulances, helicopters). To demonstrate the
safety of the device the goal is test it in a small number of healthy volunteers first.
The SONAS device will be used to detect changes in blood flow to the brain through
ultrasound, otherwise known as TransCranial Doppler (TCD). To date, the SONAS device has been
tested extensively in the laboratory, in animals and in human cadavers. The purpose of the
present study is to test the device for safety and efficacy in a small group of healthy
volunteers. This study will test the device on 10 healthy volunteers. Each volunteer will
have a physical examination, neurological examination, and brain MRI both before and after
the TCD test is performed. All of these study procedures will be performed on 1 visit,
lasting approximately 5 hours. The brain MRI's will be used to verify the effectiveness of
the SONAS device on detecting changes in blood flow to the brain.
Specific Aims: Indicate the purpose of the research, specifying the problems and/or
hypotheses to be addressed.
Aim 1: Determine safety of the SONAS device Aim 1a: Obtain perfusion MRI (PWI) / quantitative
MRI Aim 1b: Obtain MRI with gadolinium (gdMRI) Aim 2: Determine feasibility to detect
microbubble specific frequencies
Research Design and Methods: Describe in detail the design and methodology of the study.
Since this is a 'first in human' study, testing primarily for the overall safety of the
diagnostic approach, the aim is to enroll only healthy volunteers (e.g. no
cerebro-/cardio-vascular history, no vascular risk factors etc.) into the study. We
anticipate a total number of N=10 volunteers to be sufficient for this study.
Step 1 After written informed consent and prior to the SONAS ultrasound study each volunteer
will undergo a baseline assessment in form of a physical exam, including vital signs,
National Institute of Health Stroke Scale (NIHSS) assessment and Modified Ranking Scale as
well as the assessment of the Medical History.
Step 2 Next, the volunteer will undergo a cranial MRI study. The MRI study will include a
perfusion-weighted sequence to assess a baseline value for brain perfusion as well as
gadolinium-enhanced T1-weighted images to assess the integrity of the blood-brain barrier.
Step 3
After the MRI study, the volunteer will undergo the SONAS ultrasound study. The study will be
performed in supine position:
Two ultrasound transducers/probes will be positioned on both sides of the volunteer's head at
the temporal bone (above and in front of the ear on each side). To hold the
transducers/probes in place a customized headset has been designed which is easy to use and
comforting for the proband.
Step 4 An IV line will be placed in a cubital or forearm vein. To assess a baseline value,
ultrasound will be transmitted following an automated protocol to increase subsequently the
output voltage from 5 volts to 50 volts. At each voltage step the received signals will be
acquired and stored. Once the maximum output voltage of 50 Volts has been reached an
additional 10 ultrasound pulses will be transmitted and the received data acquired. The total
duration of this first data acquisition is 20 seconds.
Step 5 A bolus of 1.0ml of the ultrasound contrast agent (so called 'Microbubbles') Lumason™,
internationally known as SonoVue (Bracco Pharmaceuticals, Italy), will be injected into the
IV line, followed by a 5.0ml IV bolus injection of saline. Lumason™ has been FDA approved for
cardiac applications to opacify the left ventricular chamber and to improve the delineation
of the left ventricular endocardial border. In the context of the present study Lumason™
would be used off-label.
Step 6 Following the IV bolus injection of Lumason™, ultrasound will be transmitted and
received signals acquired following the same protocol as detailed under Step 4.
Step 7 3 -5 hours after the SONAS ultrasound study has been performed Step 1 and Step 2 will
be repeated.
hypotheses to be addressed.
Aim 1: Determine safety of the SONAS device Aim 1a: Obtain perfusion MRI (PWI) / quantitative
MRI Aim 1b: Obtain MRI with gadolinium (gdMRI) Aim 2: Determine feasibility to detect
microbubble specific frequencies
Research Design and Methods: Describe in detail the design and methodology of the study.
Since this is a 'first in human' study, testing primarily for the overall safety of the
diagnostic approach, the aim is to enroll only healthy volunteers (e.g. no
cerebro-/cardio-vascular history, no vascular risk factors etc.) into the study. We
anticipate a total number of N=10 volunteers to be sufficient for this study.
Step 1 After written informed consent and prior to the SONAS ultrasound study each volunteer
will undergo a baseline assessment in form of a physical exam, including vital signs,
National Institute of Health Stroke Scale (NIHSS) assessment and Modified Ranking Scale as
well as the assessment of the Medical History.
Step 2 Next, the volunteer will undergo a cranial MRI study. The MRI study will include a
perfusion-weighted sequence to assess a baseline value for brain perfusion as well as
gadolinium-enhanced T1-weighted images to assess the integrity of the blood-brain barrier.
Step 3
After the MRI study, the volunteer will undergo the SONAS ultrasound study. The study will be
performed in supine position:
Two ultrasound transducers/probes will be positioned on both sides of the volunteer's head at
the temporal bone (above and in front of the ear on each side). To hold the
transducers/probes in place a customized headset has been designed which is easy to use and
comforting for the proband.
Step 4 An IV line will be placed in a cubital or forearm vein. To assess a baseline value,
ultrasound will be transmitted following an automated protocol to increase subsequently the
output voltage from 5 volts to 50 volts. At each voltage step the received signals will be
acquired and stored. Once the maximum output voltage of 50 Volts has been reached an
additional 10 ultrasound pulses will be transmitted and the received data acquired. The total
duration of this first data acquisition is 20 seconds.
Step 5 A bolus of 1.0ml of the ultrasound contrast agent (so called 'Microbubbles') Lumason™,
internationally known as SonoVue (Bracco Pharmaceuticals, Italy), will be injected into the
IV line, followed by a 5.0ml IV bolus injection of saline. Lumason™ has been FDA approved for
cardiac applications to opacify the left ventricular chamber and to improve the delineation
of the left ventricular endocardial border. In the context of the present study Lumason™
would be used off-label.
Step 6 Following the IV bolus injection of Lumason™, ultrasound will be transmitted and
received signals acquired following the same protocol as detailed under Step 4.
Step 7 3 -5 hours after the SONAS ultrasound study has been performed Step 1 and Step 2 will
be repeated.
Inclusion Criteria:
- Be at least 18 years of age
- No prior history of cerebro- or cardio-vascular disease
- Be willing to comply with study protocol
- Provide written informed consent
Exclusion Criteria:
- Lumason™ is contraindicated in subjects known to have right-to-left shunts, severe
pulmonary hypertension (pulmonary artery pressure >90 mmHg), uncontrolled systemic
hypertension, and in subjects with adult respiratory distress syndrome.
- Lumason™ should not be used in combination with dobutamine in subjects with conditions
suggesting cardiovascular instability where dobutamine is contraindicated.
- Lumason™ should not be used in subjects with known hypersensitivity to the following
substances:
1. Macrogol 4000
2. Distearoylphosphatidylcholine
3. Dipalmitoylphosphatidylglycerol
4. Sodium Palmitic acid
- Female who is pregnant or a nursing mother (the possibility of pregnancy has to be
excluded by negative serum or urine HCG results, obtained within 24 hours before
Lumason™ administration, or on the basis patient history, e.g.: tubal ligation,
hysterectomy, or a minimum of 1 year history without menses
- Contraindications to MRI, pregnancy, lactation, morbid obesity, and severe
claustrophobia
- Known allergy to gadolinium
We found this trial at
1
site
757 Westwood Plaza
Los Angeles, California 90024
Los Angeles, California 90024
(310) 825-9111
Principal Investigator: David S. Liebeskind, M.D.
Phone: 310-794-0600
UCLA Medical Center Founded in 1955, UCLA Medical Center became Ronald Reagan UCLA Medical Center...
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