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临床试验/NCT04002167
NCT04002167已完成不适用

A Novel Neuromonitoring Guided Cognitive Intervention for Targeted Enhancement of Working Memory

Stanford University2 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2019年8月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
65
试验地点
2
主要终点
Change in Working Memory Performance

研究概览

简要总结

The proposed study is to test and validate a novel intervention that integrates computerized cognitive training with real-time neuromonitoring and neurofeedback to enhance working memory by probing the individualized neural systems underlying working memory. We will test the proposed intervention on children with ADHD with working memory deficits. The R61 proof-of-concept phase will assess the target engagement, effective dose and feasibility.

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
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
7 Years 至 11 Years(Child)
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

Change in Working Memory Performance

时间窗: baseline and 6 weeks

Accuracy in an N-back working memory task was calculated as the percentage of correct responses to target stimuli.

Change in Target Frontal-parietal Activity

时间窗: baseline and 6 weeks

Change in activity in the target frontal-parietal network measured by functional near infrared spectroscopy (fNIRS) during an N-back working memory task. A general linear model is applied to recorded signal and the beta coefficients from the model are extracted as a proxy for brain activity in fronto-pariteal network which subserves working memory function. There is no established population mean for beta coefficient of brain activity. Higher (lower) beta coefficients reflect higher (lower) activation in the target brain network. A positive change indicates increased brain activity. Increased frontal-parietal activity reflects better engagement of this brain network during working memory performance.

次要结局

  • Change in Conners 3rd Edition Inattention T-score(baseline and 6 weeks)
  • Change in Conners 3rd Edition ADHD Index Score(baseline and 6 weeks)
  • Change in Wide Range Assessment of Memory and Learning 2 (WRAML-2), General Memory Index Score(baseline and 6 weeks)
  • Change in Behavior Rating Inventory of Executive Function (BRIEF), Working Memory T-score(baseline and 6 weeks)
  • Change in Developmental NEuroPSYchological Assessment II (NEPSY-II) Composite Score(baseline and 6 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hadi Hosseini

Assistant Professor

Stanford University

研究点 (2)

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