Attention Deficit Hyperactivity DisorderNCT00716235
Characterization of Executive Functions and Patterns of Eye Movements in Children With Developmental Disabilities
An observational study of Attention Deficit Hyperactivity Disorder and Autistic Disorder, run by Sheba Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 4 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder, Autistic Disorder, Developmental Coordination Disorder
- How many people
- 160 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2009to Dec 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Primary care clinic
Who may be able to join
- Age of 4-10 years
- A medical diagnosis according to the relevant study group
- Normal vision without glasses or contact lens.
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Weinberg Child Development Center, Sheba Medical Center, Tel-Hashomer
Ramat Gan, 52621
About this study
The purpose of this study is to characterize the profile of executive functions and eye movements in several populations of children with developmental disabilities.
Read the 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
- Conditions
- Attention Deficit Hyperactivity Disorder, Autistic Disorder, Developmental Coordination Disorder
- Keywords
- ADHD, ASD, PDD, DCD, Executive Functions
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Autistic Disorder, Motor Skills Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2008 (estimated)
- Study startJan 2009
- Primary completionDec 2009 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Collaborators
- Bar-Ilan University, Israel
- Investigators
- Lidia Gabis, MD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00716235
- Sponsor's protocol ID
- SHEBA-08-5185-LG-CTIL
- Status last verified
- Jan 2009
- First submitted
- 15 Jul 2008
- Last updated
- 16 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Executive Functions and Patterns of Eye Movements in Children With Developmental Disabilities
- ClinicalTrials.gov ID
- NCT00716235
- Acronym / sponsor ID
- SHEBA-08-5185-LG-CTIL
- Conditions
- Attention Deficit Hyperactivity Disorder, Autistic Disorder, Developmental Coordination Disorder
- Keywords
- ADHD, ASD, PDD, DCD, Executive Functions
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Collaborators
- Bar-Ilan University, Israel
- Study start
- Jan 2009
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 16 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to characterize the profile of executive functions and eye movements in several populations of children with developmental disabilities.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Primary care clinic
Key inclusion criteria (3 listed)
- Age of 4-10 years
- A medical diagnosis according to the relevant study group
- Normal vision without glasses or contact lens.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2009.
- ISCAN Inc. - producing the eye tracking equipment for the studyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lidia Gabis, MD principal investigator
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Attention Deficit Hyperactivity Disorder and Autistic Disorder, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lidia Gabis, MD (+972-3-5302236, lidia.gabis@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2009.