Pilot Study Evaluating the Effectiveness of Neurofeedback Training in the Improvement of Cognitive Functions of the Elderly With Mild Cognitive Impairment
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change on Rey Auditory Verbal Learning test
研究概览
简要总结
The purpose of this study is to evaluate the effects of SMR neurofeedback training on cognitive performance and electrical brain activity in elderly with 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 on 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. The investigators aim to study the effects of a sensorimotor neurofeedback training protocol (SMR) on cognitive performances in elderly and to assess whether MCI patients change in brain electrical activity 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
- 65 Years 至 90 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Mild Cognitive Impairment, educational level of 9 years of studies minimum, righthandedness, subjective memory complaint confirmed by an informant, a mini mental Status Examination score > 20, preserve activity of daily living and absence of dementia.
排除标准
- •Elderly persons who were under guardianship, resident in nursing facilities, neurological disease, psychiatric disease and involved in another cognitive intervention.
研究组 & 干预措施
Sensorimotor neurofeedback training group
Three interventions will be administered :
- An electroencephalography recording (EEG) for 30 minutes with an electrocap of 19 scalp locations according to the international 10-20 EEG placement system.
- The second intervention is the neuropsychological assessments and questionnaires. They will be done in one session for approximately 2hours.
- The third intervention is the neurofeedback training sensorimotor that will be recorded at channel Cz according to the international 10-20 system.
干预措施: Neurofeedback (Behavioral)
Control Group
Three interventions will be administered :
- An electroencephalography recording (EEG) for 30 minutes with an electrocap of 19 scalp locations according to the international 10-20 EEG placement system.
- The second intervention is the neuropsychological assessments and questionnaires. They will be done in one session for approximately 2hours
- The psychopedagogical care: each session will be organized using the same video material
结局指标
主要结局
Change on Rey Auditory Verbal Learning test
时间窗: Baseline assessment in 2 weeks period before intervention, change from baseline at immediately after the end of the intervention , and after 1-month follow-up
Assessment of Verbal learning in episodic memory
次要结局
- relative power for delta, theta, alpha, sensorimotor and lower beta frequency bands.(assessment at baseline, change from baseline to immediately after the NF training and 1 month follow-up)