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Virtual Reality a Novel Screening and Treatment Aid in Attention Deficit Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00364702
Recruitment Status : Completed
First Posted : August 16, 2006
Last Update Posted : August 17, 2011
Sponsor:
Information provided by:
Shaare Zedek Medical Center

Study Description
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Brief Summary:
Using a virtual reality program in screening and treatment of ADHD.

Condition or disease Intervention/treatment Phase
ADHD Drug: methylphenidate Phase 2

Detailed Description:

Virtual Reality is a novel program designed to imitate a real classroom environment including various distractions. It includes a head monitor to track eye movements Children aged 10-20 years with ADHD will use the program with and without methylphenidate(1 mg/kg). Their results will be compared to a control group.

Parental consent will be obtained.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Virtual Reality a Novel Screening and Treatment Aid in Attention Deficit Disorder
Study Start Date : August 2006
Actual Primary Completion Date : July 2007
Actual Study Completion Date : July 2007

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Virtual Reality program test results

Eligibility Criteria
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Ages Eligible for Study:   10 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Clinical diagnosis of ADHD-DSM4 criteria AGE 10-20 YEARS normal neurological examination IQ>80

Exclusion Criteria:

ABNORMAL NEUROLOGICAL STATUS

Contacts and Locations
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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): NCT00364702


Locations
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Israel
Shaari Zedek Pediatric Neurology Unit
Jerusalem, Israel, 91031
Sponsors and Collaborators
Shaare Zedek Medical Center
Investigators
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Study Chair: V. Gross, Prof/ md Shaari Zedek Pediatric Neurology Unit
More Information
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ClinicalTrials.gov Identifier: NCT00364702    
Other Study ID Numbers: 45/04
First Posted: August 16, 2006    Key Record Dates
Last Update Posted: August 17, 2011
Last Verified: July 2006
Keywords provided by Shaare Zedek Medical Center:
Virtual Reality
ADHD
Methylphenidate
Additional relevant MeSH terms:
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Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Methylphenidate
Central Nervous System Stimulants
Physiological Effects of Drugs
 Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents