A Single Arm Study of Resting State Functional Magnetic Resonance Imaging (Rs-fMRI)-Guided Theta Burst Stimulation (TBS) in Early-Stage Alzheimer's Disease (AD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change in Connectivity Measure of the TGd Parcellations.
研究概览
简要总结
Alzheimer's disease (AD) is a progressive neurodegenerative condition affecting 6.2 million individuals in the United States, resulting in an annual cost of care of $305 billion. AD is functionally characterized by progressive degeneration of large-scale brain networks (LSBNs), including the default mode network (DMN) presumably from the deposition of amyloid plaques and neurofibrillary tangles. Available FDA-approved medications for AD such as donepezil and memantine offer limited benefit and modest impact on quality of life. 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 AD. We propose a pilot trial using rs-fMRI to target dysfunctional LSBNs in early stage AD.
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 Mild Cognitive Impairment (MCI)/mild AD
- •Evidence for Central Nervous System (CNS) amyloidosis (e.g., Amyloid positron emission tomography (PET) or cerebrospinal fluid (CSF) biomarkers consistent with AD)
- •Prior brain imaging performed
- •Mini-Mental State Examination (MMSE) >24
- •Clinical Dementia Rating (CDR) Scale 0.5-1
- •Stable dose of cholinesterase inhibitors and memantine for at least one month
- •Subjects are between 40-90 years of age
排除标准
- •Non-AD dementia including, but not limited to, 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
研究组 & 干预措施
Intermittent theta burst stimulation
All subjects will receive treatment with intermittent theta burst stimulation (iTBS). There will be a total of 5 treatments over a 2-week period. All subjects will receive iTBS to the right TGd region. TBS treatment will also be provided for two additional sites within the large-scale brain networks (LSBNs) that is found to contain the greatest number of connectivity anomalies. Total participation will be 10-12 weeks.
干预措施: Intermittent theta burst stimulation (Device)
结局指标
主要结局
Change in Connectivity Measure of the TGd Parcellations.
时间窗: 9 weeks
Assessed by calculating the difference and standard deviation between follow-up and baseline of number of abnormal connections of the TGd parcellation. Range: 0-378. There are 378 possible connections of the parcellation. Higher values indicate more abnormal connections of the TGd parcellation pre and post-treatment. The change in the number of abnormal connections of the parcellation is reported.
次要结局
未报告次要终点