Deep Brain Therapy With Low-intensity Ultrasound for Treatment of Cognitive Impairment
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Montreal Cognitive Assessment Test for Dementia (MoCA)
研究概览
简要总结
This study will evaluate a new form of non-invasive deep brain therapy for individuals with Alzheimer's disease. Low-intensity transcranial focused ultrasound stimulation will first be delivered using a range of stimulation parameters during psychophysical and physiological monitoring. A well-tolerated stimulation protocol will be selected for subsequent testing in a blinded randomized sham-controlled cross-over trial. The trial will evaluate brain target engagement using magnetic resonance imaging, PET imaging, and numerical scales of cognitive performance.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mild cognitive impairment or mild dementia due to Alzheimer's disase (AD) with confirmed AD biomarkers (Amyloid PET or CSF)
- •Age 65-80
- •MOCA > 18
排除标准
- •Evidence of cerebral amyloid angiopathy or stroke within 1 year
- •Clinical symptoms or findings suggestive of alternative diagnosis or co-pathology
- •Inability to complete MRI
- •Suicidal ideation
结局指标
主要结局
Montreal Cognitive Assessment Test for Dementia (MoCA)
时间窗: Up to 3 months following study initiation
The MoCA is a 30-point test to detect cognitive impairment. Scores range from 0 (poor) and 30 (perfect).
Hamilton Depression Rating Scale (HDRS-17)
时间窗: Up to 3 months following study initiation
This 17-item questionnaire rates the severity of depression by probing mood, feelings of guilt, suicide ideation, insomnia, agitation or retardation, anxiety, weight loss, and somatic symptoms. The scores range from 0 (no symptoms) to 52 (worst possible).
Amyloid PET
时间窗: Up to 3 months following study initiation
PET (positron emission tomography) combined with fluorine-18 labelled radiotracers provide brain scans that are interpreted as either amyloid-beta positive or negative.
次要结局
- Hopkins Verbal Learning Test-Revised (HVLT-R)(Up to 3 months following study initiation)
- Digit Span Memory Test(Up to 3 months following study initiation)
- Trail Making Test, Part A and B(Up to 3 months following study initiation)
研究者
Jan Kubanek
Assistant Professor
University of Utah