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临床试验/NCT02940457
NCT02940457撤回不适用

Verbesserung Kognitiver Fähigkeiten Bei Personen Mit Verdacht Auf Eine Leichte Kognitive Beeinträchtigung

Wuerzburg University Hospital2 个研究点 分布在 1 个国家开始时间: 2017年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Reaction times, errors and number of generated words in neuropsychological tasks

研究概览

简要总结

This study investigates the beneficial effects of prefrontal brain stimulation (with transcranial direct current stimulation [tDCS]) during working memory training in seniors with mild cognitive impairments.The placebo-controlled double blinded study includes 50 elderly patients which will be randomized into verum or sham tDCS.

详细描述

In this project, we want to test whether the effectiveness of neuropsychological exercise therapy can be increased in elderly persons suspected of having an MCI by means of parallel tDCS treatment.

All test participants train over 6 sessions within 2 weeks two different working memory tasks with increasing difficulty. In the randomized, double-blind, prospective therapy study, participants are assigned to either a Verum-tDCS or a placebo-tDCS group. The Verum-tDCS group receives active stimulation in parallel to the exercise therapy, while the placebo group does not receive tDCS stimulation. To check the effects of the therapy, we measure performance and neuronal activation in different executive tasks using near-infrared spectroscopy (NIRS). Furthermore, we will check whether the training increases the volume of the grey matter (Draganski et al., 2004, Malchow et al., 2016) and the expression of BDNF can be increased (Schuch et al., 2015).

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • suspected MCI
  • total CERAD score <= 85.1
  • MMSE >=24
  • native german speaker
  • between 50-75 years old
  • right handed

排除标准

  • impairment of daily living activities
  • psychiatric, neurological diseases
  • uncorrected hearing or vision deficits
  • actual psychopharmaca intake
  • metal parts in the head
  • medical electronical implants

结局指标

主要结局

Reaction times, errors and number of generated words in neuropsychological tasks

时间窗: 4 weeks

The Investigators are measuring cognitive performance for different executive functions

Brain activation measured with NIRS

时间窗: 4 weeks

The Investigators are measuring brain activation during executive functions

次要结局

  • T1 weighted magnetic resonance Imaging (MRI) of the brain(4 weeks)
  • Blood sampling(4 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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