NCT06169631招募中不适用
The Effects of Noninvasive Brain Stimulation on Mental States, Behavior, and Electrophysiology
Sanmai Technologies PBC dba Sanmai2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年4月29日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Hamilton Anxiety Rating Inventory
研究概览
简要总结
The purpose of the study is to test the effects of brief, low-intensity transcranial focused ultrasound (TUS) on electrophysiological, behavioral, and cognitive markers related to anxiety disorders.
详细描述
We will test the effects of TUS on self-reported and clinical anxiety states in healthy participants and in those with diagnosed anxiety disorders. Participants in these studies will receive pulsed TUS to the brain regions of interest. We will test whether multiple doses of TUS lead to larger reductions in mental states related to anxiety in comparison to a single dose of TUS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •18-65 years of age, as verified via photo identification with date of birth.
- •Should be an English speaker, as indicated by being able to read and comprehend the consent form.
- •Experiment 2 : Participants will be included for a past diagnosis of anxiety within the past year.
排除标准
- •Smokes or uses tobacco products or any form of nicotine excessively
- •History of head injury with loss of consciousness for more than 5 min
- •Uncorrected hearing or vision impairment, including color blindness
- •Currently have or history of brain or mental illness judged likely to interfere with testing, including drug and/or alcohol dependence
- •History of epilepsy
- •Brain tumors
- •Takes medications or drugs judged likely to change brain activity, including psychoactive drugs, stimulants, benzodiazepines, and/or others
- •Factors that may lead to poor EEG or fNIRS recordings (e.g., hairstyle)
- •Inadequate sleep
- •Drug, alcohol or prescription drug intoxication, dependence or addiction
- •Pregnancy, or becoming pregnant during the course of the study
- •Mild cognitive impairment or impaired decision making
- •History of migraines
- •Experience with neurostimulation (which might unbind or alter the results)
- •Metal implants in their head or face
结局指标
主要结局
Hamilton Anxiety Rating Inventory
时间窗: 1 month
Psychological questionnaire used by clinicians to rate the severity of a patient's anxiety
次要结局
未报告次要终点
研究者
研究点 (2)
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