Comparison of Effects Between SMR/Delta Ratio and beta1/Theta Ratio Neurofeedback Trainings for Older Adults With Mild Cognitive Impairment: A Protocol for a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 主要终点
- Change on attention test, TMTB-TMA
研究概览
简要总结
This is a non-pharmacological study evaluating the effects of SMR/delta ratio and beta1/theta ratio neurofeedback trainings on cognitive performance and electrical brain activity in elderly with mild cognitive impairment.
详细描述
Older adults with Mild Cognitive Impairment (MCI) are at high risk to progress to Alzheimer's disease (AD). Slowing down effect of dementia by enhancing brain plasticity represents one of the most prominent challenges. Neurofeedback is one of the promising techniques that showed therapeutic efficacy and cognitive improvement in attention-deficit hyperactivity disorder, epilepsy, stroke. We aim to study the effects of two neurofeedback training protocols, SMR/delta ratio and beta1/theta ratio, on cognitive performances in older adults with Mild Cognitive Impairment and to assess whether MCI patients change in brain electrical activity in a resting state after training.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Mild Cognitive Impairment
- •MMSE score >24
- •Subjective memory complaint confirmed by an informant.
- •Perform at/or below 1.5 standard deviations from the mean for age and education-matched norms on more than one of the neuropsychological tests.
- •Preserve activity of daily living
- •Absence of dementia.
排除标准
- •Psychiatric and neurological disorders
- •History of alcohol or other substance consumption
结局指标
主要结局
Change on attention test, TMTB-TMA
时间窗: Baseline Assessment in 2 weeks period before intervention, change from baseline at immediately after the end of the intervention and after 3-months follow-up
assessment of the Trail Making Test B and A, calculation of subtraction
次要结局
- Change on Rey Auditory Verbal Learning Test(Baseline assessment in 2 weeks period before intervention, change from baseline at immediately after the end of the intervention, and after 3-months follow-up)
研究者
Fabienne Marlats
PhD Candidate
Broca Hospital