A Single Arm Study of Resting State Functional Magnetic Resonance Imaging (Rs-fMRI)-Guided Theta Burst Stimulation (TBS) in Primary Progressive Aphasia (PPA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Connectivity Measures of the Left TGd, 55b, and STV Parcellations at Baseline and Post-treatment
研究概览
简要总结
Frontotemporal degeneration (FTD) is a non-Alzheimer's dementia that is the 2nd most common cause of dementia in the United States. FTD may present with focal language symptoms that are clinically described as primary progressive aphasia (PPA). There are two types of PPA associated with FTD-semantic variant primary progressive aphasia (SV-PPA) and nonfluent/agrammatic variant primary progressive aphasia (NFV-PPA). Both diseases are progressive neurodegenerative disease processes that compromise dominant hemisphere large scale brain network function, ultimately resulting in mutism. There are currently no FDA-approved treatments for PPA and management is mostly supportive. In combination with resting state functional MRI (rs-fMRI), transcranial magnetic stimulation (TMS) with intermittent theta burst stimulation (iTBS) offers a non-invasive alternative to pharmacotherapy in persons with PPA. In our prior studies of Alzheimer's disease (AD) and Lewy body Dementia (LBD) subjects, investigators have determined that the anterior temporal pole (area TGd and TGv) is an area that is commonly dysfunctional in dementia. The investigators have already embarked upon an fMRI guided study of iTBS in early stage Alzheimer's disease where subjects received a series of 5 treatments to distinct brain regions inclusive of area TGd. The investigators propose a case study of 3 PPA studies where rs-fMRI is applied to the large-scale language networks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Established diagnosis of NFV-PPA and SV-PPA based on criteria (Gorno-Tempini et al., 2011)
- •Prior brain imaging performed
- •Mini Mental Status Exam (MMSE)>10
- •Subjects are between 40-90 years of age
排除标准
- •Non-FTD dementia including, but not limited to Alzheimer's, disease, Lewy body dementia, frontotemporal dementia, vascular dementia, Jakob-Creutzfeldt disease, etc.
- •Inability to tolerate rs-fMRI
- •Contraindication of rs-fMRI due to implants or metal
- •Seizure disorder
结局指标
主要结局
Connectivity Measures of the Left TGd, 55b, and STV Parcellations at Baseline and Post-treatment
时间窗: 6 weeks
The difference and corresponding 95% confidence interval between follow-up and baseline connectivity measures of the TGd parcellations. Range: -1 to 1. Positive values indicate areas where connectivity is higher than healthy controls from the Human Connectome Project.
次要结局
未报告次要终点
