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

Primary Purpose

ADHD

Status

Completed

Phase

Phase 2

Locations

Israel

Study Type

Interventional

Intervention

methylphenidate

About this trial

This is an interventional diagnostic trial for ADHD focused on measuring Virtual Reality, ADHD, Methylphenidate

Eligibility Criteria

10 Years - 20 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Clinical diagnosis of ADHD-DSM4 criteria AGE 10-20 YEARS normal neurological examination IQ>80 Exclusion Criteria: ABNORMAL NEUROLOGICAL STATUS

Sites / Locations

Shaari Zedek Pediatric Neurology Unit

Outcomes

Primary Outcome Measures

Virtual Reality program test results

Secondary Outcome Measures

Full Information

NCT ID

NCT00364702

First Posted

August 15, 2006

Last Updated

August 16, 2011

Sponsor

Shaare Zedek Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT00364702

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2006

Overall Recruitment Status

Completed

Study Start Date

August 2006 (undefined)

Primary Completion Date

July 2007 (Actual)

Study Completion Date

July 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Shaare Zedek Medical Center

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

ADHD

Keywords

Virtual Reality, ADHD, Methylphenidate

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Factorial Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

methylphenidate

Primary Outcome Measure Information:

Title

Virtual Reality program test results

10. Eligibility

Sex

All

Minimum Age & Unit of Time

10 Years

Maximum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Clinical diagnosis of ADHD-DSM4 criteria AGE 10-20 YEARS normal neurological examination IQ>80 Exclusion Criteria: ABNORMAL NEUROLOGICAL STATUS

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

V. Gross, Prof/ md

Organizational Affiliation

Shaari Zedek Pediatric Neurology Unit

Official's Role

Study Chair

Facility Information:

Facility Name

Shaari Zedek Pediatric Neurology Unit

City

Jerusalem

ZIP/Postal Code

91031

Country

Israel

12. IPD Sharing Statement

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

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