Computerized Cognitive Training: Characterization of Factors That Predict Cognitive Enhancement in Acquired Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Changes in cognitive outcome measures
研究概览
简要总结
To investigate factors that predict cognitive enhancement following engagement in an intensive Computerized Cognitive Training Protocol.
详细描述
To investigate factors that predict cognitive enhancement following engagement in an intensive 6-month, 5 days per week training use the ABI Wellness BEARS platform and Brainex Software Symbol Relations Module.
The study will examine the impact of intensive working memory training on neurocognitive markers of brain plasticity (intervention-related changes) in 1) performance on neuropsychological tests, 2) BDNF levels in blood and salivary, 3) ERP measures of working memory, and 4) resting state fMRI and structural MRI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient of the Mass General Brigham Health System with primary attention and executive functioning difficulties and/or a diagnosis of mild cognitive disorder or mild neurocognitive disorder (non-amnestic profile), due to an acquired brain injury (ABI) sustained at least 12 months prior to study contact.
- •Ages 25-65 years old
- •Proficiency in English
- •Willing and able to complete all study-related activities for 12 months, including travel to Brigham and Women's Hospital (Boston) for four in-person assessment visits and two serum and saliva sample collections.
- •Access to a computer with webcam and stable internet.
- •A reliable study informant who can complete one questionnaire about participant's cognition/daily functioning, at four time points.
排除标准
- •History of alcohol or substance abuse, or dependence, within the past 2 years, as per DSM-5 criteria.
- •High likelihood of an underlying progressive neurodegenerative disorder.
- •Evidence of moderate to severe cognitive disorder, based on a score of 21 or less on the Mini-Mental Status Examination (MMSE) (Tombaugh & McIntyre, 1992).
- •Patient Health Questionnaire (PHQ)-9 (Kroenke et al., 2010) Score ≥ 19, unless deemed by treating provider not to have active depression (e.g., adjustment disorder, grief reaction).
- •Active psychotic symptoms.
- •Severe sensory losses such that participants would unlikely be able to participate in the study training, even with substantial accommodations (self-report of extreme difficulty reading ordinary newspaper print or a performance-tested corrected vision test score of worse than 20/30).
- •Communication difficulties that prevent the participant from effectively participating in this highly interactive study protocol (based on interviewer's rating of a person's ability to be understood and to understand others).
- •Current participation in a pharmacological, or other interventional research trial.
- •Life expectancy of < 2 years.
研究组 & 干预措施
Computerized Cognitive Training
See section of intervention/treatment for additional information.
干预措施: Cognitive Computerized Training (Behavioral)
结局指标
主要结局
Changes in cognitive outcome measures
时间窗: 6 months
We will use age-corrected standard scores of the NIH toolbox Total Cognitive Composite, Fluid Intelligence Composite, and individual scores on RAVLT, Verbal Fluency, and Trailmaking Task as cognitive outcome measures.
Changes in BDNF Levels in blood and saliva
时间窗: 6 months
Using FUJIFILM high sensitivity ELISA kits and commercially available ELISA kits.
次要结局
- Feelings about cognitive/thinking skills(6 months)
- Self-report exercise and physical activity(6 months)
- Intervention-related changes in ERP measures, such as the P3 component (P3a and P3b)(6 months)
- Intervention-related changes in resting state fMRI(6 months)
- Quality of life self-report(6 months)
- Sleep(6 months)
- Anxiety(6 months)
- Self-report on impact of fatigue(6 months)
- Self-report exercise and physical activity(6 months)
- Intervention-related changes in ERP measures, such as the P3 component (P3a and P3b)(6 months)
- Intervention-related changes in resting state fMRI(6 months)
- Quality of life self-report(6 months)
- Sleep(6 months)
- Anxiety(6 months)
- Depression(6 months)
- Self-report on impact of fatigue(6 months)
- Feelings about cognitive/thinking skills(6 months)
研究者
Kirk Daffner, MD
Chief, Division of Cognitive and Behavioral Neurology
Brigham and Women's Hospital