Brain and Cognitive Changes After Reasoning Training in Individuals With Cognitive Complaints
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Change From Baseline in California Verbal Learning Task Score
研究概览
简要总结
Individuals aged 55 and older may experience negative effects of cognitive decline. The proposed research seeks to evaluate the benefits of different types of interventions: reasoning training following transcranial direct current stimulation (tDCS) and reasoning training following sham transcranial direct current stimulation (tDCS) on frontal- lobe mediated cognitive measures of executive control in adults with memory complaints, in the absence of dementia.
详细描述
The purpose of this study is to evaluate the impact of reasoning training on individuals with complaints of changes in memory or thinking in the absence of dementia, when combined with transcranial current stimulation (tDCS). The reasoning training being studied is a strategy based program where individuals are taught strategies designed to engage the frontal lobes. Participants will randomly be placed into one of two groups (1) reasoning training following transcranial current stimulation (tDCS) as compared to (2) reasoning training following sham tDCS. The study will be done with adults between the ages of 50 and 80 with consistent memory complaints or lower baseline performance on memory measures. The primary hypothesis is that individuals receiving tDCS prior to brain training will have a stronger response to brain training than those in the sham tDCS group. Response to training will be measured by improved cognitive function and neural changes as measured by neuropsychological testing, MRI, and EEG. MRI will be used to evaluate the impact of reasoning training on brain blood flow, structure and function, and to measure changes in brain energy metabolism and electroencephalogram (EEG) to evaluate intervention outcomes. The reasoning training program will be conducted in small groups at the Center for BrainHealth.
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, Investigator)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Safely have an MRI
- •Cognitive complaints in the absence of dementia
- •Participate in tasks involving motor abilities such as use of at least one arm and hand
- •Read, speak, and comprehend English
- •50-80 years of age
- •Comprehend simple instructions, perform tasks, and take part in intervention
排除标准
- •Not proficient in reading, comprehending, or speaking English
- •Individuals who have any significant health, neurological, or psychiatric illness, or history of substance abuse
- •Individuals with any MR contraindications (i.e., non-removable metal within/on the body)
- •Individuals taking medications which are contraindicatory for the tDCS procedure
- •Individuals who are left-handed
- •Not proficient in reading,comprehending, and speaking English
- •Females who are not post-menopausal
- •Pre-existing cerebral palsy, autism, epilepsy, schizophrenia, pervasive developmental disorder, thyroid diseases, diabetes, claustrophobia, non-correctable vision problems, major depression, psychosis, active behavioral disorder, or uncontrolled epilepsy.
- •Women who are pregnant
结局指标
主要结局
Change From Baseline in California Verbal Learning Task Score
时间窗: Baseline to 4 weeks and 3 months post-training
To examine short-term and long-term effects of treatment on cognition and real-life outcomes. The participant will undergo neuropsychological testing at baseline, post-training (4 weeks), as well as 3-months post-training. Scores on the scale range from 0 to 16 on the California Verbal Learning Task. Higher the values are better their memory.
次要结局
- Regional Brain Blood Flow Change Immediately After 1 Month of Cognitive Training and tDCS Brain Stimulation(Two longitudinal measurements at baseline and 1-month)
研究者
Sandra Chapman, PhD
Director, Center for BrainHealth
The University of Texas at Dallas