- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00716235
Characterization of Executive Functions and Patterns of Eye Movements in Children With Developmental Disabilities
Study Overview
Status
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
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Ramat-Gan, Israel, 52621
- Recruiting
- Weinberg Child Development Center, Sheba Medical Center, Tel-Hashomer
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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DCD
Children with a diagnosis of DCD
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Autism
Children with a diagnosis of Autism disorder
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ADHD
Children with a diagnosis of ADHD
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Control
Control group - children with no neurological or psychiatric problems
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Attention Deficit and Disruptive Behavior Disorders
- Neurodevelopmental Disorders
- Child Development Disorders, Pervasive
- Autism Spectrum Disorder
- Disease
- Attention Deficit Disorder with Hyperactivity
- Autistic Disorder
- Developmental Disabilities
- Motor Skills Disorders
Other Study ID Numbers
- SHEBA-08-5185-LG-CTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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