Investigation of Low-intensity Focused Ultrasound for Human Anxiety Management
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Change in EMG eye startle reflex
研究概览
简要总结
This study is examining the effects of noninvasive brain stimulation on anxiety. Low-intensity focused ultrasound (LIFU) will be utilized to neuromodulate the brain prior to a task (NPU). Physiological recordings will be taken throughout (EEG, EMG, HR, BP, RR, GSR).
详细描述
This study is a research project examining the effects of noninvasive brain stimulation on anxiety. This study will help us to better understand possible treatments for patients diagnosed with anxiety disorders. Participants will undergo a functional magnetic resonance imaging (fMRI) and a computed tomography (CT) scan, to image the bone and brain tissue. Participants will receive noninvasive brain stimulation using low-intensity focused ultrasound (LIFU) sound waves, to temporarily change brain activity. Participants will undergo a threat task involving brief (100ms) shocks (1-5mA) and startle noises. Brain signals (EEG), muscle twitch (EMG), heart rate and rhythm, blood pressure, respiration rate, and skin moisture will be monitored throughout. Participants will be asked to complete behavioral questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Participant will experience the same setup in real and sham conditions. The gel puck used to couple the ultrasound signal will either have a blocking disk, or no blocking disk to either allow or block the ultrasound signal.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •High or low trait anxiety
排除标准
- •claustrophobia
- •Contraindications to MRI (implants)
- •Contraindications to CT (pregnancy)
- •Active medical disorder with CNS effects (e.g. Alzheimers)
- •History of neurologic disorder (e.g. Parkinson's, epilepsy)
- •History of head injury w/ LOC for >10 min
- •History of alcohol or drug dependence
- •History of current cardiovascular disease
研究组 & 干预措施
NPU
Participant will be presented with a series of images (cues) and sounds. Three conditions will occur - a no shock (N), predictable shock (P), and unpredictable shock (U). In P, shocks will only occur with the cue. In U, shocks will happen at any time. Participants will be told which condition they are in throughout the task. Startle sounds will occur throughout. 3 Study visits will occur - identical conditions for the participant, testing 2 brain regions and 1 sham visit.
干预措施: Low-intensity focused ultrasound (Device)
NPU
Participant will be presented with a series of images (cues) and sounds. Three conditions will occur - a no shock (N), predictable shock (P), and unpredictable shock (U). In P, shocks will only occur with the cue. In U, shocks will happen at any time. Participants will be told which condition they are in throughout the task. Startle sounds will occur throughout. 3 Study visits will occur - identical conditions for the participant, testing 2 brain regions and 1 sham visit.
干预措施: Low-intensity focused ultrasound - sham (Device)
NPU-c
Participants will be presented with a moving line. When the line reaches a certain point - an event will occur. This event will either be a painful shock or a monetary reward. Startle sounds will occur throughout. 3 study visits will occur - identical conditions for the participant, testing 2 brain regions and 1 sham visit.
干预措施: Low-intensity focused ultrasound (Device)
NPU-c
Participants will be presented with a moving line. When the line reaches a certain point - an event will occur. This event will either be a painful shock or a monetary reward. Startle sounds will occur throughout. 3 study visits will occur - identical conditions for the participant, testing 2 brain regions and 1 sham visit.
干预措施: Low-intensity focused ultrasound - sham (Device)
结局指标
主要结局
Change in EMG eye startle reflex
时间窗: Through study completion, an average of 2 weeks
Attenuated amplitude of startle reflex during uncertain and predictable threat tasks with lifu compared to sham.
Change in heart rate using ECG
时间窗: Through study completion, an average of 2 weeks
Attenuation of hear rate increases due to startle tasks in lifu compared to sham condition
次要结局
未报告次要终点
研究者
Wynn Legon
Assistant Professor
Virginia Polytechnic Institute and State University