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
|
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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。
一般刊物
- D'Amico D, Curone M, Erbetta A, Farago' G, Bianchi-Marzoli S, Ciasca P, Bussone G, Chiapparini L. Intracranial idiopathic hypertension: 1-year follow-up study. Neurol Sci. 2014 May;35 Suppl 1:177-9. doi: 10.1007/s10072-014-1765-x.
- Wall M. Idiopathic intracranial hypertension. Neurol Clin. 2010 Aug;28(3):593-617. doi: 10.1016/j.ncl.2010.03.003.
- Dave SB, Subramanian PS. Pseudotumor cerebri: an update on treatment options. Indian J Ophthalmol. 2014 Oct;62(10):996-8. doi: 10.4103/0301-4738.145991.
- Afonso CL, Talans A, Monteiro ML. Factors affecting visual loss and visual recovery in patients with pseudotumor cerebri syndrome. Arq Bras Oftalmol. 2015 May-Jun;78(3):175-9. doi: 10.5935/0004-2749.20150045.
- Zur D, Naftaliev E, Kesler A. Evidence of multidomain mild cognitive impairment in idiopathic intracranial hypertension. J Neuroophthalmol. 2015 Mar;35(1):26-30. doi: 10.1097/WNO.0000000000000199.
- Kharkar S, Hernandez R, Batra S, Metellus P, Hillis A, Williams MA, Rigamonti D. Cognitive impairment in patients with Pseudotumor Cerebri Syndrome. Behav Neurol. 2011;24(2):143-8. doi: 10.3233/BEN-2011-0325.
- Soiberman U, Stolovitch C, Balcer LJ, Regenbogen M, Constantini S, Kesler A. Idiopathic intracranial hypertension in children: visual outcome and risk of recurrence. Childs Nerv Syst. 2011 Nov;27(11):1913-8. doi: 10.1007/s00381-011-1470-5. Epub 2011 May 3.
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
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.