Brain and Behavioral Regulation Processes in a Population With Substance Use Disorder
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- sLORETA Brodmann Areas Voxels Z-Scores
研究概览
简要总结
The proposed project seeks to explore the effects of a neuroregulation paradigm named Z-Score Quantitative Electroencephalogram (QEEG) guided sLORETA neurofeedback (ZQLN) on optimizing brain electrophysiological activity and behavioral performance in a substance use disorder (SUD) population whose primary drug of use is cocaine.
详细描述
Aim 1. Measure the effects of ZQLN training on brain electrophysiological activation changes in SUD patients. QEEG and Event-Related Potentials procedures, recorded with a 19-channel digital EEG, will be conducted before and after 12-15 sessions of ZQLN to examine changes on dysregulated brain sites by inspection of the brain maps deviating brain areas sLORETA Brodmann Areas Voxels Z-Scores inside and outside the target window of -/+2 standard deviations. Observation of P300 component latencies and amplitudes will be measured during a Drug-cue GoNoGo paradigm.
Aim 2. Measure the effects of ZQLN training on behavioral performance changes in SUD patients. In the same participants of Aim 1, Pre and Post behavioral performance (before and after 12-15 sessions of ZQLN) includes the assessment of attention and executive function, episodic memory, working memory language, and processing speed as measured by the NIH Toolbox Cognitive Domains battery scales. Other behavioral variables include reaction times, omission, and commission errors in the Drug-cue GoNoGo task.
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
- 21 Years 至 51 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age limit: 21 to 51
- •Cocaine as a primary drug of selection
- •Be stable (such as not having reading or movement problems preventing them from using a computer keyboard or iPad).
- •Have completed the first stage of treatment in the program (this first phase consists of the stabilization and detoxification period of the program participants)
排除标准
- •History of brain injury.
- •Previous experience with neurofeedback training.
- •Being unavailable to complete assessments.
研究组 & 干预措施
QEEG-guided sLoreta Neurofeedback
Brainmaster Discovery 24 EEG amplifier and BrainAvatar software will be used to conduct the neurofeedback sessions
干预措施: QEEG-Guided sLoreta Neurofeedback Training (Device)
结局指标
主要结局
sLORETA Brodmann Areas Voxels Z-Scores
时间窗: 2 months
An increase of the percent of sLORETA Brodmann Areas Voxels Z-Scores inside the target window of -/+2 standard deviations after a series of ZQLN sessions is expected.
Event-Related Potentials P300 amplitudes Drug-cue Go
时间窗: 2 months
Brain response P300 component average amplitudes (measured in microvolts) during Drug-cue GoNoGo. task.
Event-Related Potentials P300 latencies
时间窗: 2 months
Brain response P300 component average latencies (measured in milliseconds) Drug-cue GoNoGo task.
次要结局
- Attentional Executive Functioning NIH Toolbox Task(2 months)
- Working Memory NIH Toolbox Task(2 months)
- Executive Function NIH Toolbox Task(2 months)
- Processing Speed NIH Toolbox Task(2 months)
- Drug-cue NoGo Task Commission Errors(2 months)
- Drug-cue Go Task Reaction Times(2 months)
- Episodic Memory NIH Toolbox Task(2 months)
- Drug-cue Go Task Omission Errors(2 months)