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Characterization of Executive Functions and Patterns of Eye Movements in Children With Developmental Disabilities

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ClinicalTrials.gov Identifier: NCT00716235
Recruitment Status : Unknown
Verified January 2009 by Sheba Medical Center.
Recruitment status was:  Recruiting
First Posted : July 16, 2008
Last Update Posted : January 16, 2009
Sponsor:
Collaborator:
Bar-Ilan University, Israel
Information provided by:
Sheba Medical Center

Brief Summary:
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 or disease
Attention Deficit Hyperactivity Disorder Autistic Disorder Developmental Coordination Disorder

Detailed Description:

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:

  • Intelligence tests (according to the child's age)
  • Communication: DSM-IV, ADOS, Stony Brook questionnaire
  • Motor / Coordination: Movement Advanced Battery for Children (M-ABC)
  • Attention: Conners Rating Scales - Revised (CRS-R 3rd ed.)
  • Sleep: Sleep habits questionnaire

Executive functions will be assessed using the following methods:

  • NEPSI-II
  • BRIEF questionnaire
  • Wisconsin Card Sorting Test
  • Tower of Hanoi

Eye movements will be measured using an infra-red video camera produced by ISCAN inc. the following visual stimuli will be presented:

  • Human faces presenting various emotions
  • Various objects
  • Saccade and anti-saccade tasks

Study Type : Observational
Estimated Enrollment : 160 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Characterization of Executive Functions and Patterns of Eye Movements in Children With Developmental Disabilities
Study Start Date : January 2009
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
DCD
Children with a diagnosis of DCD
Autism
Children with a diagnosis of Autism disorder
ADHD
Children with a diagnosis of ADHD
Control
Control group - children with no neurological or psychiatric problems




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Ages Eligible for Study:   4 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Primary care clinic
Criteria

Inclusion Criteria:

  • Age of 4-10 years
  • A medical diagnosis according to the relevant study group
  • Normal vision without glasses or contact lens.

Exclusion Criteria - clinical groups:

  • Intelligence Quotient below 70
  • A known brain damage
  • A known hearing impairment
  • Regular use of medications (except for psychostimulants)
  • Evidence for a known genetic syndrome
  • History of fetal CMV infection, birth asphyxia, major head injury or epilepsy

Exclusion Criteria - control group:

  • Intelligence Quotient below 70
  • Regular use of medications
  • Evidence for a neurological / psychiatric disorder, birth injury, developmental delay, head injury, or other medical disorders that affect the central nervous system
  • Family History - first degree) of autism, DCD, ADHD or other neurological/psychiatric disorder

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00716235


Contacts
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

Locations
Israel
Weinberg Child Development Center, Sheba Medical Center, Tel-Hashomer Recruiting
Ramat-Gan, Israel, 52621
Sponsors and Collaborators
Sheba Medical Center
Bar-Ilan University, Israel
Investigators
Principal Investigator: Lidia Gabis, MD Sheba Medical Center

Additional Information:
Responsible Party: Lidia Gabis, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT00716235     History of Changes
Other Study ID Numbers: SHEBA-08-5185-LG-CTIL
First Posted: July 16, 2008    Key Record Dates
Last Update Posted: January 16, 2009
Last Verified: January 2009

Keywords provided by Sheba Medical Center:
ADHD
ASD
PDD
DCD
Executive Functions

Additional relevant MeSH terms:
Disease
Attention Deficit Disorder with Hyperactivity
Autistic Disorder
Developmental Disabilities
Motor Skills Disorders
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Child Development Disorders, Pervasive