NCT02857335

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2016

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2016

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 5, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

August 5, 2016

Status Verified

August 1, 2016

Enrollment Period

7 months

First QC Date

July 28, 2016

Last Update Submit

August 2, 2016

Conditions

Prospective Study , Questionaires

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Non-Verbal Memory

    once

  • Go-No Go Test

    once

  • Stroop Interference

    once

  • Visual Spatial Processing

    once

  • Staged Information Processing Speed

    once

  • +2 more secondary outcomes

Study Arms (1)

study group

OTHER

patients with benign intracranial hypertension ages 8-16 years

Behavioral: neurocognitive tests

Interventions

neurocognitive testsBEHAVIORAL

Subjects will undergoe a battery of neurocognitive testing which will test memory, flexible thought process, problem, attention span

study group

Eligibility Criteria

Age8 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • co morbidities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • 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.

    PMID: 24867861BACKGROUND

  • Wall M. Idiopathic intracranial hypertension. Neurol Clin. 2010 Aug;28(3):593-617. doi: 10.1016/j.ncl.2010.03.003.

    PMID: 20637991BACKGROUND

  • 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.

    PMID: 25449933BACKGROUND

  • 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.

    PMID: 26222108BACKGROUND

  • 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.

    PMID: 25383589BACKGROUND

  • 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.

    PMID: 21606575BACKGROUND

  • 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.

    PMID: 21538129BACKGROUND

Related Links

MeSH Terms

Interventions

Mental Status and Dementia Tests

Intervention Hierarchy (Ancestors)

Neuropsychological TestsPsychological TestsBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2016

First Posted

August 5, 2016

Study Start

January 1, 2016

Primary Completion

August 1, 2016

Study Completion

November 1, 2016

Last Updated

August 5, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will share