Neurofeedback-enhanced Mindfulness Meditation for the Treatment of Affective and Attentional Disturbances in Patients With Traumatic Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Change in Neurobehavioral Symptom Inventory
研究概览
简要总结
Spaulding Rehabilitation Hospital is conducting a research study evaluating the effectiveness of the brain-training product, MUSE, an EEG-guided neurofeedback device designed to assist in cultivating a relaxed, attentive state of mind during meditation. The investigators study aims to evaluate whether such a tool could be useful in treating persistent traumatic brain injury symptoms such as inattention, impulsivity, irritability, or dysregulated mood.
详细描述
Twenty subjects in total will participate in this study. Subjects will be randomized to focused-attention meditation training with or without the neurofeedback device, MUSE. Subjects will be asked to practice ~10 min of daily meditation for 6-8 weeks. Neuropsychological testing will be performed at the beginning of the study and after six weeks of training. At this time point, those randomized to the non-MUSE group will be given a device and asked to train for an additional two weeks. At the conclusion of the study, all subjects will also undergo a brief telephone or in-person exit interview regarding their experiences using the MUSE device.
Primary endpoint: change in Neurobehavioral Symptom Inventory
Secondary endpoints: change in the following: Wechsler Adult Intelligence Scale-IV Digit Span and Symbol-Digit Coding, Trail-Making Test, Beck Anxiety Inventory, Beck Depression Inventory, Cognitive and Affective Mindfulness Scale-Revised, percentage of EEG activity associated with alpha, beta, or theta activity.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •history of mild-moderate traumatic brain injury
- •impaired attention or concentration
- •>1 year since traumatic brain injury
- •ability to participate in neurofeedback and mindfulness meditation
- •daily access to a smart phone
- •on stable dosage of neuropsychological medications with no significant changes planned for the duration of the study
- •no prior history of a meditation practice
排除标准
- •severe mental illness or psychological symptoms (severe depression, suicidality, disabling anxiety, PTSD, psychosis, dissociation)
- •significant pre-morbid learning disability
- •current or recent (in past year) history of significant drug or alcohol abuse
- •medical illness severe enough to result in an attentional disorder
- •neurodegenerative disease
- •non-fluency in English.
结局指标
主要结局
Change in Neurobehavioral Symptom Inventory
时间窗: baseline and six weeks
Measures common symptoms after head injury. This scales ranges from 0-4 on 22 items, for a minimum score of 0 and a maximum score of 88. Higher scores mean a greater severity of symptoms.
次要结局
- Change in Trail Making Test(baseline and six weeks)
- Change in Beck Depression Inventory-II(baseline and six weeks)
- Change in Wechsler Adult Intelligence Scale-IV Digit Symbol Coding(baseline and six weeks)
- Change in Beck Anxiety Inventory(baseline and six weeks)
- Change in Cognitive and Affective Mindfulness Scale-Revised(baseline and six weeks)
- Change in Wechsler Adult Intelligence Scale-IV Digit Span(baseline and six weeks)
- Change in Percentage of EEG Activity Associated With Alpha, Beta, and Theta Rhythms as Measured by Surface Electrodes on the MUSE Device(baseline and at six weeks)
研究者
Mel B. Glenn
Director of Outpatient and Community Brain Injury Rehabilitation
Spaulding Rehabilitation Hospital