Ultrasonic Deep Brain Stimulation During Anesthetic Sedation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Blood Oxygen Level Dependent (BOLD) Response to Visual Stimuli
研究概览
简要总结
The purpose of this study is to see if mental functions take place during different levels of anesthesia. The researchers expect to gain a deeper understanding of mental function during different levels of anesthesia, and to evaluate if the use of ultrasonic brain stimulation accelerates return to consciousness.
详细描述
The decision was made in 2023 to focus on the Central Thalmus arm only for this trial. Participants were only randomized to this arm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The participants will be right-handed adults
- •Body mass index (BMI) less than
- •All subjects will be English speakers.
排除标准
- •Participants will be excluded if they have any medical contraindication to MRI scanning
- •Unable to undergo MRI scanning because of possible pregnancy or currently breastfeeding,
- •Metallic substances in the body, claustrophobia, anxiety, or cardiopulmonary disease;
- •Intracranial structural abnormality on T1-weighted MRI scans.
- •Potential subjects will be excluded if they have a history of allergy to propofol, eggs or egg products, soybean or soybean products,
- •Neurological, cardiovascular, or pulmonary illness;
- •Head injury with loss of consciousness;
- •Learning disability or other developmental disorder; sleep apnea or any severe snoring history;
- •Gastroesophageal reflux disease (GERD) or heartburn;
- •Pancreatitis or a history of pancreatitis, or sensory/motor loss sufficient to interfere with performance of the study. Participants with tattoos in the head or neck region will be excluded from study; other tattoos are subject to determination by investigators based on their assessment regarding participant safety. To eliminate aspiration risk subjects will also be excluded if they have had recent food or liquid intake (within 8 hours). Subjects will be excluded if they have a history of drug use, have a positive drug screen, are unwilling to abstain from alcohol for 24 hours prior to dosing, or have a current history of nicotine use. Women will be required to take a pregnancy test prior to participation to ensure a negative result. The pre-scan drug screen and pregnancy test will be paid for by the study.
结局指标
主要结局
Blood Oxygen Level Dependent (BOLD) Response to Visual Stimuli
时间窗: Up to 90 minutes
BOLD signal was measured by Magnetic Resonance Imaging (MRI) scanning of the brain in response to a visual stimuli. This method reflected changes in oxygenation of blood in the brain during a scene-processing task.
次要结局
- Perceptual Criterion Derived From the Signal Detection Theory (SDT)(Up to 90 minutes)
- Grip Force(Up to 90 minutes)
- Sensitivity Derived From the Signal Detection Theory (SDT)(Up to 90 minutes)
研究者
Zirui Huang
Research Assistant Professor, Anesthesiology and Research Fellow
University of Michigan