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

This study has been completed.
Sponsor:
Information provided by:
Shaare Zedek Medical Center
ClinicalTrials.gov Identifier:
NCT00364702
First received: August 15, 2006
Last updated: August 16, 2011
Last verified: July 2006
History of Changes
  Purpose

Using a virtual reality program in screening and treatment of ADHD.


Condition Intervention Phase
ADHD
 Drug: methylphenidate
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Virtual Reality a Novel Screening and Treatment Aid in Attention Deficit Disorder

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Shaare Zedek Medical Center:

Primary Outcome Measures:
  • Virtual Reality program test results

Estimated Enrollment: 40
Study Start Date: August 2006
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   10 Years to 20 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00364702

Locations
Israel
Shaari Zedek Pediatric Neurology Unit
Jerusalem, Israel, 91031
Sponsors and Collaborators
Shaare Zedek Medical Center
Investigators
Study Chair: V. Gross, Prof/ md Shaari Zedek Pediatric Neurology Unit
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00364702     History of Changes
Other Study ID Numbers: 45/04
Study First Received: August 15, 2006
Last Updated: August 16, 2011
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Shaare Zedek Medical Center:
Virtual Reality
ADHD
Methylphenidate

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Methylphenidate
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013