Modulating Ventral Striatal Activity and Connectivity With Transcranial Focused Ultrasound as a Putative Novel Intervention for Cocaine Use Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Ventral striatum (VS) activity to prediction error before receiving tFUS to the VS
研究概览
简要总结
The investigators aim to examine the immediate effect of transcranial focused ultrasound (tFUS) on brain activity in healthy adults.
详细描述
The investigators will examine ventral striatum (VS) target engagement by tFUS in healthy adults 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
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •No present/lifetime history of major depressive disorder (MDD), psychosis, Bipolar Disorder; Hamilton Depression Rating Scale (HDRS)>7; Young Mania Rating Scale (YMRS)>10), borderline personality disorder, and present suicidal ideation
- •No family history of MDD, psychosis, Bipolar Disorder, or epilepsy
排除标准
- •Present/lifetime history of MDD, psychosis, Bipolar Disorder (HDRS>7; YMRS>10), borderline personality disorder, and present suicidal ideation. Childhood history of, but not present, anxiety disorders and Attention-deficit/hyperactivity disorder (ADHD) will be allowed as these are common disorders in childhood
- •Family history of MDD, psychosis, Bipolar Disorder, or epilepsy
- •History of head injury, neurological (e.g., epilepsy), pervasive developmental disorder (e.g., autism), systemic medical disease and treatment (medical records, participant report)
- •Use of substances with seizure risk (e.g., stimulants) in the past month, as for other non-invasive neuromodulation techniques, assessed as screening and before each tFUS session
- •Mini-Mental State Examination (MMSE) score (cognitive state) <24
- •Premorbid North American Adult Reading Test (NAART) intelligence quotient (IQ) estimate <85;
- •Visual disturbance: <20/40 (Snellen visual acuity)
- •Left/mixed handedness (Annett criteria)
- •History of alcohol or other substance use disorder (SUD), daily nicotine use, and/or illicit substance use over the last 3 months (SCID-5). Note: lifetime/present cannabis use (<3 times in the past month) at non-SUD levels will be allowed, given its common usage in young adults. Urine tests on scan days will exclude current illicit substance use. Salivary alcohol tests on scan days will exclude intoxicated individuals
- •Binge drinking (as defined by National Institute on Alcohol Abuse and Alcoholism (NIAA) criteria: consuming 5 or more drinks (male), or 4 or more drinks (female), in about 2 hours.) in the week before, and/or >3 drinks/day for the 3 days before, and/or alcohol in the last 12 hrs before, any alcohol on tFUS scan day, confirmed at screening and scan days. Alcohol/nicotine/caffeine/cannabis use (below SCID-5 SUD and binge levels) will be allowed
- •MRI exclusion criteria: metallic objects, e.g., surgical implants; claustrophobia; positive pregnancy test for females or self-report pregnancy
- •Unable to understand English
- •Taking any psychotropic medications in the past 3 months
- •Any implanted neural device
- •Color blind
研究组 & 干预措施
VS tFUS/Sham tFUS
VS tFUS (tFUS applied to the ventral striatum) Sham tFUS (go through the motions of applying tFUS to the VS)
干预措施: tFUS (Device)
VS tFUS/Sham tFUS
VS tFUS (tFUS applied to the ventral striatum) Sham tFUS (go through the motions of applying tFUS to the VS)
干预措施: Sham tFUS (Device)
Sham tFUS/VS tFUS
VS tFUS (tFUS applied to the ventral striatum) Sham tFUS (go through the motions of applying tFUS to the VS)
干预措施: tFUS (Device)
Sham tFUS/VS tFUS
VS tFUS (tFUS applied to the ventral striatum) Sham tFUS (go through the motions of applying tFUS to the VS)
干预措施: Sham tFUS (Device)
结局指标
主要结局
Ventral striatum (VS) activity to prediction error before receiving tFUS to the VS
时间窗: Two visits over up to 8 weeks
Measure of ventral striatum (VS) activity to prediction error before receiving tFUS to the VS
Ventral striatum (VS) activity to prediction error after receiving tFUS to the VS
时间窗: Two visits over up to 8 weeks
Measure of ventral striatum (VS) activity to prediction error after receiving tFUS to the VS
次要结局
未报告次要终点
研究者
Mary Phillips, MD MD (Cantab)
Professor
University of Pittsburgh