Virtual Reality a Novel Screening and Treatment Aid in At... | NCT00364702

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

NCT00364702

Sponsor

Shaare Zedek Medical Center

Status

Completed

Last Update Posted

Aug 17, 2011Estimated

Enrollment

40Estimated

Phase

Phase 2

Conditions

ADHD

Interventions

methylphenidate

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2006

Primary Completion Date

Jul 2007Actual

Completion Date

Jul 2007Actual

First Submitted Date

Aug 15, 2006

First Submission Date that Met QC Criteria

Aug 15, 2006

First Posted Date

Aug 16, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 16, 2011

Last Update Posted Date

Aug 17, 2011Estimated

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Name	Type	Description	Arm Group Labels	Other Names
methylphenidate	Drug

Measure	Description	Time Frame
Virtual Reality program test results

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

ABNORMAL NEUROLOGICAL STATUS

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

20 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
V. Gross, Prof/ md	Shaari Zedek Pediatric Neurology Unit	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shaari Zedek Pediatric Neurology Unit		Jerusalem		91031	Israel

Condition Browse Module

MeSH Terms

ID	Term
D001289	Attention Deficit Disorder with Hyperactivity

Ancestor Terms

ID	Term
D019958	Attention Deficit and Disruptive Behavior Disorders
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008774	Methylphenidate

Ancestor Terms

ID	Term
D010648	Phenylacetates
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided