Virtual Reality and Diagnostic of Attention Deficit Hyperactivity Disorder (ADHD) (PADA1)

NCT ID: NCT04561713

Last Updated: 2025-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-21
• Study Completion Date: 2022-05-05

Brief Summary

The aim of this study is to develop an application in order to identify the most relevant cognitive and behavioral parameters for the diagnosis of Attention Deficit Hyperactivity Disorder (ADHD) in conditions closer to reality

Detailed Description

Attention Deficit Hyperactivity Disorder (ADHD) is the most common neurodevelopmental disorder in school-aged children. This disorder is characterized by a symptomatic triad associating, inattention, hyperactivity and impulsivity. Cognitive, emotional and behavioral dysfunctions have a strong impact on the school, family and social domains of the child. The clinical diagnosis of ADHD is all the more difficult because there are currently no biological, clinical or psychological markers that accurately measure the symptoms of ADHD. The diagnosis is made during interviews with specialist doctors allowing the collection of information from parents and the child. Virtual reality technology is most recognized as a tool for assessment, rehabilitation of cognitive processes and functional skills. In addition to traditional diagnostic assessment methods, a virtual reality application in an immersive room (CAVE) in three dimensions could objectively assess the child in a dynamic environment that is as close as possible to everyday situations

Conditions

Attention Deficit Hyperactivity Disorder

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Attention Deficit Hyperactivity Disorder (ADHD)

Children aged 8 to 12 diagnosed with ADHD

Group Type: EXPERIMENTAL

Virtual reality task

Intervention Type: PROCEDURE

Virtual reality application in an immersive room (CAVE) in three dimensions to assess child's sustained attention in a dynamic environment that is as close as possible to everyday situations.

Control

Control group of healthy ADHD children matched in age, gender and laterality to children in ADHD group

Group Type: SHAM_COMPARATOR

Virtual reality task

Intervention Type: PROCEDURE

Virtual reality application in an immersive room (CAVE) in three dimensions to assess child's sustained attention in a dynamic environment that is as close as possible to everyday situations.

Interventions

Virtual reality task

Virtual reality application in an immersive room (CAVE) in three dimensions to assess child's sustained attention in a dynamic environment that is as close as possible to everyday situations.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

Group of children with ADHD :

• Children aged 8 to 12 diagnosed with ADHD (according to DSM-V criteria)
• Positive ADHD diagnosis with standardized maintenance of Kiddie-Sads
• Naïve drug treatment for ADHD
• Schooled in a classic environment
• Intellectual Quotient> 80 (4 subtests of WASI, or WISC IV-R / WISC-V less than 2 years old)
• Having French as mother tongue
• Children benefiting from a social security scheme
• Signing of free, informed and written consent by the child and the holders of parental authority Group of children controls

Children aged 8 to 12 years undiagnosed ADHD (according to DSM-V criteria) :

• Not presenting with ADHD at standardized maintenance Kiddie-Sads
• Schooled in a classic environment
• Intellectual Quotient> 80 (4 subtests of WASI)
• Having French as mother tongue
• Children benefiting from a social security scheme
• Signing of free, informed and written consent by the child and the holders of parental authority

Exclusion Criteria

• Positive diagnosis with standardized maintenance of Kiddie-Sads for the following disorders: mood disorders, psychotic disorders, autism spectrum disorders, severe anxiety disorders and severe tic disorders
• Presenting a hearing or vision diagnosis diagnosed that does not allow the task to be performed in virtual reality
• Neurological disorders
• Photosensitive Epilepsy (contraindication to immersion in virtual reality)
• Treatment with psychostimulants or other psychotropic drugs
• Unable to complete the virtual reality task during the familiarization session

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Arthur MICOULAUD-FRANCHI

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Locations

CHU de Bordeaux

Bordeaux, , France

Countries

France

Other Identifiers

2018/33

Identifier Type: -

Identifier Source: org_study_id