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临床试验/NCT05910749
NCT05910749撤回不适用

Brain and Behavioral Regulation Processes in a Population With Substance Use Disorder

University of Puerto Rico2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2025年4月1日最近更新:
适应症

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

入选标准

  • 未提供

排除标准

  • 未提供

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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