Neurofeedback and Follow-up With Real-time fMRI to Investigate Cognitive Function in Patients of Mild Cognitive Impairment (MCI) or Alzheimer's Disease (AD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 主要终点
- Visual and Verbal Memory Test (VVM)
研究概览
简要总结
The project aims to investigate in patients of Alzheimer's disease in a prodromal state (early state of the disease) compared to healthy subjects whether neurofeedback training with functional MRI (fMRI) can improve cognitive ability. It is of interest if voluntary modulation of brain activation with real-time (rt) fMRI as a novel method affects cognitive ability, as well as functional and structural measures of the brain.
Over the course of the study subjects will learn a real-world footpath. During neurofeedback training subjects are then asked to recall this footpath while simultaneously trying to modulate their own brain activation based on feedback. Feedback is given about the parahippocampal gyrus - a region of the brain associated with episodic and visuo-spatial memory, which is known to be affected early by Alzheimer's disease pathology.
Before and after the training cognitive ability is assessed using neuropsychological tests mainly measuring numerous domains of memory.
The investigators hypothesise that the training leads to an improvement of the trained cognitive domain, but also induces changes in brain structure and function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Healthy subjects in the sham feedback condition were not aware of their group membership, but were debriefed at the end of the study.
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Native speakers of German
- •Naive to neurofeedback experiments
- •Ability to provide written informed consent
排除标准
- •Metallic implants (MR-safety)
- •Neurological/psychiatric disease (except Alzheimer's disease in the patient group)
- •Use of psychoactive medication (expect medication for Alzheimer's disease)
- •Familiarity with the study site
结局指标
主要结局
Visual and Verbal Memory Test (VVM)
时间窗: 2.5 weeks
Neuropsychological assessment including visuo-spatial memory
次要结局
- Wechsler Memory Scale Revised (WMS-R)(2.5 weeks)
- Montreal Cognitive Assessment (MoCA)(2.5 weeks)
- Trail Making Test (TMT)(2.5 weeks)
- Visual Patterns Test (VPT)(2.5 weeks)
- Parahippocampal activation(2.5 weeks)
- Memory-related functional connectivity using Granger Causality Analysis (GCA)(2.5 weeks)
- Change of brain structure(2.5 weeks)
- Change of brain function(2.5 weeks)
研究者
Kathrin Reetz
Head of Memory Clinic and/or Principal Investigator
University Hospital, Aachen