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临床试验/NCT02332525
NCT02332525Unknown1 期

The Influence of Oral Vibrational Stimulation on Brain Activity and Cognitive Function of Elderly Individuals With Mild Cognitive Impairment

Seoul National University Bundang Hospital0 个研究点目标入组 20 人开始时间: 2015年1月最近更新:
适应症

试验速览

阶段
1 期
入组人数
20
主要终点
cognitive function

研究概览

简要总结

The purpose of this study is to investigate the effect of oral vibratory stimulus on the brain activity and cognitive function of elderly people with non-dementia subjects (cognitive normal, mild cognitive impairment)

详细描述

Evaluating the effect of oral vibratory stimulus on the brain activity and cognitive function of elderly people with mild cognitive impairment

◇ Test design: Open-labeled, prospective, pre-post study

○ Oral vibratory stimulus: As an optimal algorithm drawn through the first year study, the vibratory stimulus is applied 10 times for 15 days (a 5-minute stimulus is applied two times a day for 10 days, and it is composed of repeated 15-second vibratory and 15-second non-vibratory stimulus with a strength of 3.3V).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

cognitive function

时间窗: 15 days

Cambridge Neuropsychological Test Automated Battery (CANTAB, Cambridge Cognition, Cambridge, United Kingdom) (Sahgal, et al., 1992; Blackwell, et al., 2004; O'Connell, et al., 2004; Junkkila, Oja, Laine, \& Karrasch, 2012) 1. Paired Associates Learning (PAL) : Memory function 2. Spatial Working Memory (SWM): frontal-executive function 3. Stockings Of Cambridge (SOC): spatial planning ability and problem-solving ability

次要结局

  • quantitative electroencephalography (QEEG) and event-related potentials (ERPs)(15 days)
  • functional magnetic resonance imaging (fMRI)(15 days)
  • masticatory ability(15 days)
  • salivary secretion(15 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lee, Hyo-Jung

assistant professor

Seoul National University Bundang Hospital

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