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| Sponsor: | Sheba Medical Center |
|---|---|
| Collaborator: |
Bar-Ilan University, Israel |
| Information provided by: | Sheba Medical Center |
| ClinicalTrials.gov Identifier: | NCT00716235 |
Purpose
The purpose of this study is to characterize the profile of executive functions and eye movements in several populations of children with developmental disabilities.
| Condition |
|---|
|
Attention Deficit Hyperactivity Disorder Autistic Disorder Developmental Coordination Disorder |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Characterization of Executive Functions and Patterns of Eye Movements in Children With Developmental Disabilities |
| Estimated Enrollment: | 160 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
DCD
Children with a diagnosis of DCD
|
|
Autism
Children with a diagnosis of Autism disorder
|
|
ADHD
Children with a diagnosis of ADHD
|
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Control
Control group - children with no neurological or psychiatric problems
|
Abnormal Executive function (EF) profile was considered a major characteristic of Attention deficit / hyperactivity disorder (ADHD) and autism, and is frequently implicated in Developmental coordination disorder (DCD) children as well. The scientific literature implies that the EF profile among these three groups share some common abnormalities, but differ significantly in specific features. Abnormal EF profile may be a core feature of the developmental trajectory of each syndrome.
The fine measurement of eye movements may shed light on the underlying mechanisms of specific disorders, and point to abnormal attention, information processing, or motor organization. Gaze is an important component of social interaction. Eye contact and recognition of other's gaze direction are crucial to empathy assessment.
The current study will embark in the assessment of a wide range of EF in these populations and in a matched control group, as well as their relation to other important parameters such as daily function skills and comorbid neurobehavioral characteristics. It will also assess the pattern of eye movements in response to various visual stimuli in these populations. The main purpose is to characterize the similarities and differences of each of these populations, in terms of EF and eye movements.
Assessment methods:
Clinical parameters:
Executive functions will be assessed using the following methods:
Eye movements will be measured using an infra-red video camera produced by ISCAN inc. the following visual stimuli will be presented:
Eligibility| Ages Eligible for Study: | 4 Years to 10 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Primary care clinic
Inclusion Criteria:
Exclusion Criteria - clinical groups:
Exclusion Criteria - control group:
Contacts and Locations| Contact: Lidia Gabis, MD | +972-3-5302236 | lidia.gabis@sheba.health.gov.il |
| Contact: Raanan Raz, Ph.D | +972-3-5302236 | Raanan.Raz@sheba.health.gov.il |
| Israel | |
| Weinberg Child Development Center, Sheba Medical Center, Tel-Hashomer | Recruiting |
| Ramat-Gan, Israel, 52621 | |
| Principal Investigator: | Lidia Gabis, MD | Sheba Medical Center |
More Information
| Responsible Party: | Lidia Gabis, Sheba Medical Center |
| ClinicalTrials.gov Identifier: | NCT00716235 History of Changes |
| Other Study ID Numbers: | SHEBA-08-5185-LG-CTIL |
| Study First Received: | July 15, 2008 |
| Last Updated: | January 15, 2009 |
| Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
|
ADHD ASD PDD DCD Executive Functions |
|
Autistic Disorder Developmental Disabilities Motor Skills Disorders Attention Deficit Disorder with Hyperactivity Hyperkinesis Ataxia Child Development Disorders, Pervasive |
Mental Disorders Diagnosed in Childhood Mental Disorders Attention Deficit and Disruptive Behavior Disorders Dyskinesias Neurologic Manifestations Nervous System Diseases Signs and Symptoms |