Personalized Ultrasonic Brain Stimulation for Depression: A Pilot Study of Target Engagement and Mood Effects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Target engagement: MRI quantification of brain activation
研究概览
简要总结
This study will evaluate a new form of non-invasive brain stimulation for individuals with depression. Personalized low-intensity transcranial focused ultrasound stimulation will first be delivered using a range of stimulation parameters during psychological and physiological monitoring. A well-tolerated stimulation protocol will then be selected for subsequent testing in a blinded randomized sham-controlled cross-over trial to evaluate brain target engagement using magnetic resonance imaging.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- 否
入选标准
- •Age 18-65, any gender
- •Primary diagnosis of major depressive disorder or bipolar disorder
- •Current moderate-to-severe depressive episode, without psychotic features, lasting at least 2 months
- •Self-rated 16-item Quick Inventory of Depressive Symptomatology (QIDS) total score > 10
- •Stated willingness to comply with all study procedures and avoid changes to psychiatric treatments (medications, psychotherapy) for the duration of the study
- •For females of reproductive potential: negative pregnancy test or use of highly effective contraception for at least 1 month prior to baseline; agreement to use such a method throughout the study
- •Capacity to provide informed consent; provision of a signed and dated consent form
排除标准
- •History of serious brain injury or other neurologic disorder
- •Poorly managed general medical condition
- •Pregnant or breast feeding
- •Implanted device in the head or neck
- •MRI intolerance or contraindication
- •Brain stimulation (e.g., ECT, TMS, VNS) in the past month
- •Suicidal ideation (Columbia Suicide Severity Rating Scale screen item #2, past month)
- •Lifetime history of a serious suicide attempt
- •Moderate-to-severe substance use disorder (past 3 months)
- •Obsessive compulsive disorder (past month)
- •Posttraumatic stress disorder (past month)
- •Schizophrenia-spectrum disorder (lifetime)
- •Neurocognitive disorder (past year)
- •Personality disorder as a current focus of treatment
- •Clinically inappropriate for participation in the study as determined by the study team
研究组 & 干预措施
Active stimulation
Personalized low-intensity transcranial focused ultrasound stimulation of deep brain target (subgenual cingulate or alternative targets)
干预措施: Diadem prototype (Device)
Sham stimulation
Personalized low-intensity transcranial focused ultrasound stimulation of lateral ventricle
干预措施: Diadem prototype (Device)
结局指标
主要结局
Target engagement: MRI quantification of brain activation
时间窗: 1 day at MRI study visit
Blood oxygenation level dependent (BOLD) or arterial spin labeling (ASL) response to active versus sham stimulation
Target engagement: MRI quantification of brain connectivity
时间窗: 1 day at MRI study visit
Resting functional connectivity of target in response to active versus sham stimulation
Change in Sadness scale of PANAS-X
时间窗: 1 hour, at stimulation study visit
Positive and Negative Affect Schedule Extended (PANAS-X), range 0-100, higher score represents greater sadness
Change in depression severity measured with the HDRS-6
时间窗: 1 day and 7 days after stimulation
6-item Hamilton Depression Rating Scale (HDRS-6), range 0-22, higher score represents greater depression
次要结局
未报告次要终点
研究者
Brian Mickey
Professor of Psychiatry
University of Utah