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临床试验/NCT03325205
NCT03325205已完成不适用

MR Guided tDCS: The Effect of Repeated Transcranial Direct Current Stimulation on Cognitive Functioning in Alzheimer's Disease

University of Tromso1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2017年8月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
19
试验地点
1
主要终点
Performance on Neuropsychological tests

研究概览

简要总结

The purpose of the study is to investigate the effect of High Density- tDCS (HD- tDCS) on cognitive function in Alzheimer's Disease. One anode and four return electrodes are placed over DLPFC, where low intensity current (2mA) is induced to the surface of the scalp. Electrode placement is individualized for each participant. Participants will undergo 15 stimulations, with a duration of 20 minutes each. All patients will undergo neuropsychological assessment and MRI evaluation.

详细描述

The project will be run as a Randomized Controlled Trial (RCT), where patients will be randomized to receive either active anodal tDCS or sham tDCS. The performance on neuropsychological tests will be the primary outcome variables in the present project. In addition, whole brain MRI volume measures will be used to measure specific effects of tDCS treatment. Electrode placement is individualized for each participant with brain modeling techniques.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
50 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Alzheimer's Disease, mild and moderate stage

排除标准

  • •Other neurological diseases or injuries
  • •Psychiatric disorders (moderate/ severe depression, psychosis)

研究组 & 干预措施

Active tDCS

Experimental

Participants receive anodal tDCS over DLPFC. Each sessions lasts for 20 minutes, with a total of 15 stimulations: 6 acute sessions, 9 maintenance sessions.

干预措施: Anodal tDCS (Other)

Sham tDCS

Sham Comparator

Participants receive sham tDCS over DLPFC. Each sessions lasts for 20 minutes, with a total of 15 stimulations: 6 acute sessions, 9 maintenance sessions.

干预措施: Sham tDCS (Other)

结局指标

主要结局

Performance on Neuropsychological tests

时间窗: 4 months

Compare scores before and after tDCS stimulation

次要结局

  • Hippocampal volume(4 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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