NCT02227953Unknown不适用
A Pilot Study for the Improvement of Cognitive Function (ADAS-Cog 11) After Transcranial Direct Current Stimulation in Mild to Moderate Alzheimer's Disease
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in cognitive function
研究概览
简要总结
The primary objective of this preliminary study is to investigate whether the transcranial direct current stimulation (tDCS) improves the cognitive function in patients with Alzheimer's disease
详细描述
Twenty patients were recruited and randomized to receive either real or sham-tDCS over the left (anode) and right (cathode) dorsolateral prefrontal cortex (DLPFC). Their legally responsible caregivers were provided with mobile tDCS device, and were instructed to use it on the patients at home. 30-minute session of the stimulation were applied everyday in the morning for 12 weeks. The patients were evaluated at baseline, at week 6 and 12.
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
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who have Korean version of Mini Mental Status Examination score 10 to 24
- •Subjects who have SVLT and RCFT delayed recall test scores lower than 1.5SD
- •Subjects who have had other cognitive impairments besides memory
- •Subjects who have Seoul-Instrumental Activities of Daily Living score (S-IADL) of 8 or more.
- •Subjects who are only dementia of Alzheimer's type
- •Subjects who are right-handed
- •Subjects who are able to read and write
- •Both patient and legally responsible caregiver has provided informed consent
- •According to the latest MRI result, periventricular white matter cap or band is less than 10mm, or the deep white matter hyper-intensity is less than 25 mm
排除标准
- •Subjects who have a history of stroke and seizures
- •Subjects who have any illnesses that may disturb the patients completing the trials, including stroke, Parkinson's disease, type 1 diabetes, uncontrollable high blood pressure, Huntington's disease, cerebral palsy, liver failure, nephritis, encephalitis, meningitis, scleroma, seizures and a transient ischemic attack.
- •Subjects who have a History of DSM-IV Axis I disorders
- •Subjects who have neurologic problems on physical examination that cause memory disturbances
- •Subjects who have Extremely sensitive skin
- •Subjects who have suffered from the cancer in 3 years
- •Subjects who have had a cerebrovascular neurosurgery in medical history
- •Subjects who have dyspnea in sitting position
- •Subjects who have problems with memory, language and problem-solving for 2 hours after the heart attack.
- •Subjects who have a history of drug or alcohol abuse (in the past 5 years)
- •Subjects who have a history of mental or emotional disorders (in the past 5 years)
- •Subjects who have been lapsed into unconsciousness for an hour because of other reasons than general anesthesia
- •Subjects who have a history of hospitalization due to head injury
- •Subjects who are unable to read even with glasses
- •Subjects who are unable to understand the conversation due to the hearing defect (even with the hearing aid)
结局指标
主要结局
Change in cognitive function
时间窗: from baseline to Week 6 and Week 12
Measured by ADAS-Cog 11
次要结局
- Change in questionnaire(from baseline to Week 12)
- Change in Korean version of Geriatric Depression Scale (K-GDS)(from baseline to Week 6 and Week 12)
- Change in tDCS feedback(Week 2, 4, 6 and 12)
- Change in cognitive function(from baseline to Week 6 and Week 12)
- Change in activities of daily living(from baseline to Week 12)
- Change in behavioral symptoms(from baseline to Week 6 and Week 12)
- Change in Clinician's Interview-Based Impression of Change Plus (CIBIC plus)(from baseline to Week 12)
研究者
Duk Lyul Na
Professor of Neurology, Sungkyunkwan University School of Medicine
Samsung Medical Center
研究点 (2)
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