Modulation of Visual-Spatial Learning in Patients With Mild Cognitive Impairment (MCI) by Transcranial Direct Current Stimulation - Proof of Principle and Mechanisms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Performance in LOCATO task (Visual-spatial learning and memory) after a combination of intensive visual-spatial training and tDCS
研究概览
简要总结
The aim of this study is to investigate whether a combination of intensive training of visual-spatial abilities (LOCATO task) with anodal transcranial direct current stimulation (tDCS) leads to an improvement in learning and memory in patients with mild cognitive impairment (MCI) and to examine the underlying neuronal mechanism.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(MCI patients):
- •right handedness
- •amnestic and amnestic plus MCI with:
- •subjective memory impairment;
- •objective memory difficulties, at least 1 SD below gender, age and education adjusted standard values;
- •relatively normal performance in other cognitive domains;
- •no constraints in activities of daily livings
- •age: 50-90 years
排除标准
- •severe internal or psychiatric disease
- •other severe neurological diseases, e.g. previous major stroke or brain tumor
- •DMS-IV manifest dementia
- •contraindication for MRT (claustrophobia, metallic implants, tattoos)
研究组 & 干预措施
training + tDCS
Combination of intensive training of visual-spatial abilities (LOCATO task) with anodal transcranial direct current stimulation (tDCS)
干预措施: tDCS (Device)
training + tDCS
Combination of intensive training of visual-spatial abilities (LOCATO task) with anodal transcranial direct current stimulation (tDCS)
干预措施: training (Behavioral)
training + sham stimulation
Combination of intensive training of visual-spatial abilities (LOCATO task) with sham stimulation
干预措施: tDCS (Device)
training + sham stimulation
Combination of intensive training of visual-spatial abilities (LOCATO task) with sham stimulation
干预措施: training (Behavioral)
结局指标
主要结局
Performance in LOCATO task (Visual-spatial learning and memory) after a combination of intensive visual-spatial training and tDCS
时间窗: immediately after end of a 3-day period of training in tDCS condition vs sham condition
Investigation whether the combination of intensive visual-spatial training (LOCATO task) and tDCS leads to improvement of visual-spatial learning and memory measured by performance in LOCATO task after end of a 3 day period of training compared to sham stimulation.
次要结局
- Quality of Life(after 1 month vs baseline)
- memory(immediately after end of 3-day of cognitive training, after 1 month vs. baseline)
- affective state(immediately after the end of 3-day cognitive training, after 1 month vs. baseline)
- long term effects(after 1 month vs baseline)
- functional changes: Connectivity(end of 3-day cognitive training vs baseline)
- cortical excitability(at baseline)
- genotyping of learning related polymorphisms(once)
研究者
Agnes Flöel
Prof. Dr.
Charite University, Berlin, Germany