NCT05194332撤回不适用
Transcranial Low Intensity Focused Ultrasound Neuromodulation as a Probe to Study Human Emotion and Cognitive Function
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Changes in amygdala activity indicated by functional magnetic resonance imaging (fMRI) scan blood oxygen-level-dependent (BOLD) signal
研究概览
简要总结
The purpose of this study is to assess the low-intensity focused ultrasound pulsation (LIFUP) neuromodulation on emotion processing in healthy individuals, and to assess the overall safety of the LIFUP to stimulate or inhibit brain activity in healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must be right-handed
- •Must be illicit drug-free at the time of scanning as appropriate (verified by negative urine drug screen)
- •Must be healthy (without medical, neurological, psychiatric illness)
- •Must be psychotropic medication free (≥ 14 days)
排除标准
- •Must not be a smoker
- •Females must not be pregnant or nursing
- •Must not suffer from claustrophobia
- •Must not meet exclusion criteria for MRI scanning (i.e., non-fixed magnetizable objects)
- •Must not have ongoing, chronic, or relapsing/remitting medical, psychiatric,or neurological illness as determined by a combination of history, medical record, and/or examination.
研究组 & 干预措施
LIFUP sonication to the amygdala
Experimental
干预措施: LIFUP sonication to the amygdala (Device)
结局指标
主要结局
Changes in amygdala activity indicated by functional magnetic resonance imaging (fMRI) scan blood oxygen-level-dependent (BOLD) signal
时间窗: baseline, 5 mins post-LIFUP sonication
Changes in brain resting state functional network as indicated by fMRI scan connectivity measures
时间窗: baseline, 10-20 mins post-LIFUP sonication
次要结局
- Change in performance on Reward Task(baseline, 1-hour post-LIFUP sonication)
- Tolerability of LIFUP sonication as assessed number of adverse events(baseline, immediately after LIFUP sonication)
研究者
Jair Soares
Professor
The University of Texas Health Science Center, Houston
研究点 (1)
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