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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02857335
Recruitment Status : Unknown
Verified August 2016 by Hillel Yaffe Medical Center.
Recruitment status was:  Active, not recruiting
First Posted : August 5, 2016
Last Update Posted : August 5, 2016
Information provided by (Responsible Party):
Hillel Yaffe Medical Center

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Prospective Study , Questionaires Behavioral: neurocognitive tests Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Neurocognitive Outcome in Children Who Suffered From Idiopathic Increased Intracranial Hypertension (IIH)
Study Start Date : January 2016
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
study group
patients with benign intracranial hypertension ages 8-16 years
Behavioral: neurocognitive tests
Subjects will undergoe a battery of neurocognitive testing which will test memory, flexible thought process, problem, attention span

Primary Outcome Measures :
  1. neurocognitive outcomes [ Time Frame: 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.

Secondary Outcome Measures :
  1. Non-Verbal Memory [ Time Frame: 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

  2. Go-No Go Test [ Time Frame: 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

  3. Stroop Interference [ Time Frame: 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.

  4. Visual Spatial Processing [ Time Frame: 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

  5. Staged Information Processing Speed [ Time Frame: 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.

  6. cognitive domains [ Time Frame: 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

  7. Problem Solving [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Exclusion Criteria:

  • co morbidities

Additional Information:
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Responsible Party: Hillel Yaffe Medical Center Identifier: NCT02857335    
Other Study ID Numbers: HYMC-0100-15
First Posted: August 5, 2016    Key Record Dates
Last Update Posted: August 5, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Intracranial Hypertension
Vascular Diseases
Cardiovascular Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases