SONAS Ultrasound Device for the Detection of Ischemic and Hemorrhagic Stroke
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Blood brain barrier impairment by extravasation of Gadolinium into the brain tissue
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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:
- •Macrogol 4000
- •Distearoylphosphatidylcholine
- •Dipalmitoylphosphatidylglycerol
- •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
研究组 & 干预措施
Healthy Volunteers
干预措施: SONAS Ultrasound Device (Diagnostic Test)
Healthy Volunteers
干预措施: Lumason (Drug)
结局指标
主要结局
Blood brain barrier impairment by extravasation of Gadolinium into the brain tissue
时间窗: 5 hours
BBB impairment will be assessed by extravasation of Gadolinium into the brain tissue. Because of its molecular weight Gadolinium cannot enter the extravascular space, unless the BBB integrity is impaired. BBB impairment causes leakage of Gadolinium in into the extravascular space which, in turn, can be visualized by T1-weighted sequences.
次要结局
未报告次要终点
研究者
David Liebeskind
Professor of Neurology
University of California, Los Angeles