Restoration of Consciousness With Ultrasonic Deep Brain Stimulation During Anesthetic Sedation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- Functional connectivity (e.g., Pearson correlation coefficient) of Blood Oxygen Level Dependent (BOLD) time courses
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 using two commonly used drug (propofol and dexmedetomidine) and will include low-intensity focused ultrasound pulsation (LIFUP) to stimulate specific areas of the brain while undergoing functional Magnetic Resonance Imaging (fMRI or "brain imaging"), which shows areas in the brain involved in thinking at different depths of anesthesia. That is, ultrasound is being used to stimulate the brain and multiple pictures will be taken of the brain.
As a result of this study, we 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 FDA determined this trial is a non-significant risk (NSR) device study. Although Propofol and Dexmedetomidine, which are FDA-approved drugs for use in patients undergoing an anesthetic for medical treatment, will be used in this trial, the FDA determined that the trial will not be studying these drugs. Rather, the FDA determined this trial will be studying the NSR device. To ensure consistency with the FDA's determination, the field for "U.S. FDA-regulated Drug" in this record has been marked as "No."
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
- •Healthy study participants with American Society of Anesthesiologists (ASA) Physical Status Classification System-1 status
- •The participants will be right-handed adults
- •Body mass index (BMI) less than
- •All subjects will be English speakers.
排除标准
- •Medical contraindication to MRI scanning; are unable to undergo MRI scanning because of possible pregnancy or currently breastfeeding,
- •metallic substances in the body, claustrophobia, anxiety, or cardiopulmonary disease; or have an intracranial structural abnormality on T1-weighted MRI scans.
- •History of allergy to propofol, dexmedetomidine, any components of propofol or dexmedetomidine, eggs or egg products, soybean or soybean products,
- •Neurological, cardiovascular, or pulmonary illness;
- •Significant 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; epilepsy/seizure disorder (including a history of seizures) or stroke (including a history of stroke).
- •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.
- •Recent food or liquid intake (within 8 hours).
- •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. -----Negative pregnancy test result, if applicable.
- •Potential participants who have participated in a clinical trial using an investigational drug or device within 30 days will be considered for enrollment after 30 days.
研究组 & 干预措施
Dexmedetomidine & DLPFC pulsation
干预措施: Dorsolateral prefrontal cortex (DLPFC) pulsation (Device)
Propofol & Central thalamus (CT) pulsation
干预措施: Central thalamus (CT) pulsation (Device)
Propofol & Dorsolateral prefrontal cortex (DLPFC) pulsation
干预措施: Propofol for fMRI (Procedure)
Dexmedetomidine & AIC pulsation
干预措施: Dexmedetomidine for fMRI (Procedure)
Dexmedetomidine & AIC pulsation
干预措施: Anterior insular cortex (AIC) pulsation (Device)
Dexmedetomidine & CT pulsation
干预措施: Dexmedetomidine for fMRI (Procedure)
Dexmedetomidine & CT pulsation
干预措施: Central thalamus (CT) pulsation (Device)
Propofol & Central thalamus (CT) pulsation
干预措施: Propofol for fMRI (Procedure)
Propofol & Dorsolateral prefrontal cortex (DLPFC) pulsation
干预措施: Dorsolateral prefrontal cortex (DLPFC) pulsation (Device)
Propofol & Anterior insular cortex (AIC) pulsation
Dexmedetomidine & DLPFC pulsation
干预措施: Dexmedetomidine for fMRI (Procedure)
结局指标
主要结局
Functional connectivity (e.g., Pearson correlation coefficient) of Blood Oxygen Level Dependent (BOLD) time courses
时间窗: Up to 90 minutes
次要结局
- Grip force (in mmHg) of participants' hand squeezing on a rubber ball in response to instructions(Up to 90 minutes)
研究者
Zirui Huang
Research Assistant Professor of Anesthesiology and Co-Director, Center for Consciousness Science
University of Michigan