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

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00716235
• Other study ID #: SHEBA-08-5185-LG-CTIL
• Status: Unknown status
• Phase: N/A
• First received: July 15, 2008
• Last updated: January 15, 2009
• Start date: January 2009
• Est. completion date: December 2009

Study information

• Verified date: January 2009
• Source: Sheba Medical Center
• Contact: Lidia Gabis, MD
• Phone: +972-3-5302236
• Email: lidia.gabis[@]sheba.health.gov.il
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 160
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Autistic Disorder
• Developmental Coordination Disorder
• Developmental Disabilities
• Disease
• Motor Skills Disorders

Locations

Country	Name	City	State
Israel	Weinberg Child Development Center, Sheba Medical Center, Tel-Hashomer	Ramat-Gan

Sponsors (2)

Lead Sponsor	Collaborator
Sheba Medical Center	Bar-Ilan University, Israel

Country where clinical trial is conducted

Israel, 

External Links

•   ISCAN Inc. - producing the eye tracking equipment for the study