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Neurocognitive Outcome in Children Who Suffered From Idiopathic Increased Intracranial Hypertension (IIH)

2016年8月2日 更新者:Hillel Yaffe Medical Center
15 patients, Ages 8-17 who were diagnosed in the recent years with Idiopathic increased intracarnial hypertension (IIH) went through a battery of neurocognitive tests to establish whether there was any affect of the disease on their cognitive function

研究概览

研究类型

介入性

注册 (实际的)

15

阶段

  • 不适用

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

8年 至 17年 (孩子)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • children who suffered from IIH based on history, physical examination, ophtalmological exam, LP results, Brain imagining

Exclusion Criteria:

  • co morbidities

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
其他:study group
patients with benign intracranial hypertension ages 8-16 years
Subjects will undergoe a battery of neurocognitive testing which will test memory, flexible thought process, problem, attention span

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
neurocognitive outcomes
大体时间:once
The computerized battery of tests used in this study (testing time: 30 minutes) sampled non-verbal memory, executive function, visual spatial processing, attention, motor skills, problem solving, and information processing speed. Outcome parameters for tests or test levels included accuracy, reaction time (RT), standard deviation (SD) of RT, and a composite score ([accuracy/RT] · 100). Normalized subsets of outcome parameters were averaged to produce 7 summary scores. The outcome parameters contributing to each index score were included. The Global Cognitive Score (GCS) was computed as the average of the index scores.
once

次要结果测量

结果测量
措施说明
大体时间
Non-Verbal Memory
大体时间:once
Eight pictures of simple geometric objects were presented, followed by a recognition test, in which 4 versions of each object were presented, each oriented in a different direction
once
Go-No Go Test
大体时间:once
A series of large colored stimuli were presented at pseudorandom intervals. Participants were instructed to respond as quickly as possible by pressing a mouse button if the color of the stimulus was any color except red, for which no response was made
once
Stroop Interference
大体时间:once
Participants were presented with a pair of large colored squares, one on the left and the other on the right side of the screen. In each phase, the participants were instructed to choose as quickly as possible which of the 2 squares was a particular color.
once
Visual Spatial Processing
大体时间:once
Computer-generated scenes containing a red pillar were presented. Participants were instructed to imagine viewing the scene from the vantage point of the red pillar. Four alternative views of the scene were shown as choices
once
Staged Information Processing Speed
大体时间:once
comprises 3 levels of information processing load: single digits, 2-digit arithmetic problems.For each of the 3 levels, stimuli were presented at 3 different fixed rates, incrementally increasing as testing continues.
once
cognitive domains
大体时间:once
Participants had to "catch" a rectangular white object falling vertically from the top of the screen before it reached the bottom of the screen. Pressing on the mouse button moved a rectangular green "paddle" horizontally so that it could be positioned directly in the path of the falling object. The test required hand-eye coordination, scanning, and rapid responses
once
Problem Solving
大体时间:once
Pictorial puzzles of gradually increasing difficulty were presented. Each puzzle consisted of a 2 · 2 array containing 3 black and white line drawings and a missing element. Participants had to choose the best fit for the fourth (missing) element of the puzzle from among 6 possible alternatives.
once

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2016年1月1日

初级完成 (预期的)

2016年8月1日

研究完成 (预期的)

2016年11月1日

研究注册日期

首次提交

2016年7月28日

首先提交符合 QC 标准的

2016年8月2日

首次发布 (估计)

2016年8月5日

研究记录更新

最后更新发布 (估计)

2016年8月5日

上次提交的符合 QC 标准的更新

2016年8月2日

最后验证

2016年8月1日

更多信息

与本研究相关的术语

其他研究编号

  • HYMC-0100-15

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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