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

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

Study Overview

• Status: Unknown
• Conditions: Prospective Study , Questionaires
• Intervention / Treatment: Behavioral: neurocognitive tests

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 17 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• co morbidities

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
neurocognitive outcomes	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Non-Verbal Memory	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	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	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	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	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	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	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

Collaborators and Investigators

• Sponsor: Hillel Yaffe Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Anticipated): August 1, 2016
• Study Completion (Anticipated): November 1, 2016

Study Registration Dates

• First Submitted: July 28, 2016
• First Submitted That Met QC Criteria: August 2, 2016
• First Posted (Estimate): August 5, 2016

Study Record Updates

• Last Update Posted (Estimate): August 5, 2016
• Last Update Submitted That Met QC Criteria: August 2, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypertension; Intracranial Hypertension
• Other Study ID Numbers: HYMC-0100-15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES