Influence of Transcranial Direct-current Stimulation on Cortical Plasticity in Patients With Dementia of the Alzheimer Type
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- the anodal transcranial direct current stimulation over the primary motor cortex (M1) in patients with dementia of Alzheimer type (DAT)
研究概览
简要总结
The aim of this study is to investigate whether the anodal transcranial direct current stimulation (tDCS) over the primary motor cortex (M1) in patients with dementia of the Alzheimer type (DAT) leads to an increase in cortical plasticity (change in motor evoked potentials (MEP) in mV).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- 否
入选标准
- •Right-handed according to the Oldfield Händigkeits inventory (lateralization index> 70) (1971)
- •Cognitive impairment, which corresponds to a mild to moderate DAT
- •No treatment with AChE inhibitors, or existing stable treatment with AChE inhibitors for over 3 months
- •No motor impairments relevant to everyday life
- •Age 50 to 80 years
- •Existing Insurance certificate
- •Existing informed consent
排除标准
- •Severe neurological / psychiatric or pre-existing internist conditions because additional cognitive deficits are expected
- •Epilepsy, epileptic seizure in medical history
- •Cognitive deficit (MMSE <20)
- •Depressive episode (Beck Depression Inventory (BDI)> 12)
- •intake of centrally active drugs <3 months, particularly acetylcholinesterase inhibitors
- •Pregnancy
- •Pacemaker (contraindication for MRI)
- •Other metal parts in the body (contraindication for MRI)
研究组 & 干预措施
transcranial direct current stimulation
干预措施: transcranial direct current stimulation (Device)
sham stimulation
干预措施: sham stimulation (Device)
结局指标
主要结局
the anodal transcranial direct current stimulation over the primary motor cortex (M1) in patients with dementia of Alzheimer type (DAT)
时间窗: 1 week
to investigate whether the anodal transcranial direct current stimulation over the primary motor cortex (M1) in patients with dementia of Alzheimer type (DAT) increases cortical plasticity (measured via motor evoked potentials) compared to a sham stimulation
次要结局
- tDCS effects on central cholinergic activity in patients with DAT(1 week)
- tDCS effects on learning(1 week)
- MR elastography(1 week)
- genetic polymorphism, ApoE4(once)
研究者
Agnes Flöel
Prof. Dr.
Charite University, Berlin, Germany