COgnitive REhabilitation During Transcranial Direct Current Stimulation for Major or Mild Neurocognitive Disorder Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Attrition rate due to adverse events
研究概览
简要总结
The purpose of this study is to explore whether active transcranial direct current stimulation during cognitive rehabilitation tasks can boost cognitive enhancement without severe side effects in mild cognitive impairment or mild dementia patients.
详细描述
This study explores the additive effect of transcranial direct stimulation compared to sham stimulation during cognitive rehabilitation tasks in mild cognitive impairment or mild dementia patients. Potential participants are recruited by physicians' referral or self-entry. Informed consent by a clinical research coordinator and research physician is performed followed by screening. Participants who passed screening go through 10 sessions of active or sham transcranial direct current stimulation and are evaluated their cognitive function at screening, at the end, and two weeks after the intervention. For quality assurance, independent researcher regularly monitor and audit as participants are enrolled in the trial.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •participants with a diagnosis of either major neurocognitive disorder or mild neurocognitive disorder, defined in Diagnostic and Statistical Manual of Mental disorder (DSM-5)
- •taking the stable dose of psychotropic medication, such as cholinesterase inhibitors or NMDA(N-methyl-D-aspartate) receptor antagonist, for the past two weeks
- •ambulant by oneself with or without aiding devices.
排除标准
- •with severe psychotic symptoms requiring antipsychotic treatment
- •with risks of hospitalization within 6 weeks because of severe depression and/or suicide ideation
- •clinically contraindicated to electroconvulsive therapy (ECT) or transcranial direct current stimulation (tDCS)
- •with the Mini-Mental State Examination (MMSE) score of less than 18 or the Clinical Dementia Rating Scale (CDR) score of more than 2,
- •unable to participate for more than 2 days during the trial
- •unable to write a sentence or copy a figure on MMSE at screening.
结局指标
主要结局
Attrition rate due to adverse events
时间窗: up to two weeks
次要结局
- difference of Clinical Dementia Rating scale - sum of boxes(up to four weeks)
- difference of the mini mental state examination(up to four weeks)
- Attrition rate for any reason(up to four weeks)
- difference of Frontal Assessment Battery(up to four weeks)
- difference of Alzheimer Disease Assessment Scale -Cognitive subscale(up to four weeks)
- difference of Mini Mental State Examination(up to four weeks)