Prospective Study , Questionaires Clinical Trial
Official title:
Neurocognitive Outcome in Children Who Suffered From Idiopathic Increased Intracranial Hypertension (IIH)
| Verified date | August 2016 |
| Source | Hillel Yaffe Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Israel: Ministry of Health |
| Study type | Interventional |
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
| Status | Active, not recruiting |
| Enrollment | 15 |
| Est. completion date | November 2016 |
| Est. primary completion date | August 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 8 Years to 17 Years |
| Eligibility |
Inclusion Criteria: - children who suffered from IIH based on history, physical examination, ophtalmological exam, LP results, Brain imagining Exclusion Criteria: - co morbidities |
Intervention Model: Single Group Assignment, Masking: Open Label
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Hillel Yaffe Medical Center |
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Wall M. Idiopathic intracranial hypertension. Neurol Clin. 2010 Aug;28(3):593-617. doi: 10.1016/j.ncl.2010.03.003. — View Citation
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | No |