NCT05875181撤回不适用
Examining the Impact of Transcranial Focused Ultrasound (tFUS) on Reward Neural Circuitry
Mary Phillips, MD MD (Cantab)2 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2023年6月19日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Blood oxygen level-dependent (BOLD) signal
研究概览
简要总结
The investigators aim to examine the immediate effect of transcranial focused ultrasound (tFUS) on brain activity and emotions in healthy adults as a first stage toward understanding the predisposing brain mechanisms of underlying substance use disorders.
详细描述
In a small pilot study the investigators propose to demonstrate feasibility of using tFUS to target the ventral striatum (VS) in humans by examining VS target engagement by tFUS in healthy human volunteers using a reward processing task that reliably activates the VS.
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 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-35 years of age
- •No psychiatric history
排除标准
- •Not between 18-35 years of age
- •Has psychiatric history
- •History of head injury, neurological, pervasive developmental disorder (e.g. autism), systemic medical disease and treatment (medical records, participant report)
- •Mini-Mental State Examination (MMSE) score (cognitive state) <24
- •Premorbid North American Adult Reading Test (NAART) intelligent quotient (IQ) estimate<85
- •Visual disturbance: <20/40 Snellen visual acuity
- •Left/mixed handedness (Annett criteria)
- •History of alcohol/substance use disorder (SUD) (all substances, including nicotine), and/or illicit substance use (except cannabis) over the last 6 months (Structured Clinical Interview for Diagnostic and Statistic Manual of Mental Disorders , 5th Edition (DSM-5) (SCID-5)). Urine tests on scan days will exclude current illicit substance use (except cannabis). Salivary alcohol tests on scan days will exclude intoxicated individuals
- •Magnetic resonance imaging (MRI) exclusion: metallic objects, e.g., surgical implants; claustrophobia; positive pregnancy test for females or self-report pregnancy
- •Unable to understand English
- •Individuals with a positive pregnancy test will be excluded from the study and not undergo a computerized tomography (CT) scan or MRI scan
- •Present or history of seizure disorder
结局指标
主要结局
Blood oxygen level-dependent (BOLD) signal
时间窗: 30-60 minutes
The blood oxygen level-dependent (BOLD) signal indicates brain activity and connectivity
次要结局
未报告次要终点
研究者
Mary Phillips, MD MD (Cantab)
Professor
University of Pittsburgh
研究点 (2)
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