The Influence of Oral Vibrational Stimulation on Brain Activity and Cognitive Function of Elderly Individuals With Mild Cognitive Impairment
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
- 是
入选标准
- •A person who has at least 20 natural teeth, including the first molars (including fixed prostheses and implants, excluding removable prostheses)
- •A person who has systemic health, including controlled hypertension/hypotension and diabetes patients
- •An elderly person who has been diagnosed with normal cognition or mild cognitive impairment in a neuropsychological test and CERAD clinical evaluation (refer to separate inclusion criteria)
排除标准
- •A person who has medical history of nervous system disease
- •A person who is has ever been allergic to resin
- •A person who has untreated periodontal disease and/or severely loose teeth
- •A person who has a medical treatment history of temporomandibular disorders, who has an occurrence of stomatitis once or more per month within the last 6 months, or who currently has stomatitis
- •A person who is receiving or has received treatment for major mental diseases such as dementia, major depression, or mania based on the DSM-IV diagnosis
- •A person who has a medical disease that can have a serious effect on cognitive function or is taking related medicine
- •A person who has a transplant that is electrically or mechanically operated or a cerebrovascular clip or who has claustrophobia so that an MRI scan is impossible
研究组 & 干预措施
Intervention
20 elders (10 mild cognitive impairment, 10 cognitive normal elders) those who received oral vibrational stimulation
干预措施: Oral Vibrational Stimulation (Device)
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
Lee, Hyo-Jung
assistant professor
Seoul National University Bundang Hospital