EEG Markers of Training-Induced Improvements in Cognitive Functioning
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Composite Score of Attention and Executive Functioning From a Neurocognitive Test Battery
研究概览
简要总结
Some of the most common, persistent, and disabling consequences of traumatic brain injury affect an individual's ability to achieve personal goals. Interventions that strengthen abilities such as being able to concentrate, remember, stay calm and overcome challenges, could have far reaching benefits for Veterans. One challenge in rehabilitation is that response to training can be highly variable, and a better understanding of the neural bases for this variability could inform care. This pilot project will test the clinical behavioral effects of a cognitive skill training intervention and explore to what extent changes in markers of the brain's electrical activity (using the non-invasive technique of electroencephalograms, EEG) can explain differences in responses to skill training.
详细描述
Detailed Description: Traumatic brain injuries (TBI) can impair cognitive functioning long after the initial trauma. Some of the most common, persistent, and disabling consequences of traumatic brain injury are deficits in higher order cognitive functions that direct more basic processes based on an individual's goals. Symptoms such as distractibility and difficulty holding goal-relevant information in memory can affect achievement of personal and professional goals. These cognitive problems can be exacerbated by post-traumatic stress (PTS) symptoms, commonly observed in the Veteran population. Interventions that strengthen goal-directed regulation of cognitive-emotion states could have far reaching benefits for Veterans.
One challenge in rehabilitation is that response to training can be highly variable, and a better understanding of the neural bases for this variability could inform patient care. Investigators have developed a system for training neurocognitive skills that can be used in rehabilitation neuroscience studies to elucidate the neural bases of improvements in cognitive functioning. The training system is designed to help patients improve goal-directed brain state regulation, and preliminary work has investigated brain network parameters that may predict response to training. Electroencephalography (EEG) potentially provides easily accessible markers for the neural bases of improvements with training.
Objectives in this pilot study are to investigate the potential of EEG markers to: (1) explain differential responses to attention regulation training; and (2) predict responses to training.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of TBI (as defined by the American Congress of Rehabilitation Medicine and VA, with reported plausible mechanism of head injury, loss of consciousness with some period of posttraumatic alteration in cognition), in the chronic, stable phase of recovery (>6 months from injury)
- •On stable psychoactive medications (> 30 days)
- •Able and willing to participate in EEG, training and, assessments
排除标准
- •Severely apathetic/abulic, aphasic, or other reasons for being unable or unwilling to participate with the training tasks
- •Severe cognitive dysfunction
- •History of neurodevelopmental abnormalities
- •Ongoing illicit drug or alcohol abuse
- •Schizophrenia
- •Bipolar disorder
- •History of other neurological disorders
- •Current medical illnesses that may alter mental status or disrupt participation in the study
- •Active psychotropic medication changes
- •There will be no restriction in regard to gender, race, and socioeconomic status
结局指标
主要结局
Composite Score of Attention and Executive Functioning From a Neurocognitive Test Battery
时间窗: Week 8, after the intervention period
The investigators created a composite score based upon standardized performance on the following neurocognitive measures of attention and executive functions: Wechsler Adult Intelligence Test - 4th Edition- letter number sequence; Auditory Consonant Trigrams - 9, 18, 36 second conditions; Digit Vigilance Test - Total Errors; Delis-Kaplan Executive Function System Color-Word Interference Trials 3 and 4 - Time and Total Errors; \& Trails B - Time. Performance on each measure was scored using populations norms, and these scores are then standardized (Z-scored) and averaged to create a composite outcome (the unit measure being Z-score). A Z-score reflects the number of standard deviations a given score is away from the population mean: A Z-score of 0 is equal to the population mean, with positive and negative values reflecting performances above and below the population mean, respectively. Change will be analyzed for this data as change from before to after the intervention period.
次要结局
- Change in Event-Related Potential (ERP) Related to Memory Retrieval (Measured in uV)(Week 8, after the intervention period)
- Event-Related Potential (ERP) Related to Memory Retrieval (Measured in uV)(Week 1, before the intervention period)
- Network Modularity From EEG(Week 8, after the intervention period)