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

NCT04561713 | Completed

• 1 other identifier: 2018/33
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

Attention Deficit Hyperactivity Disorder; Virtual reality

Outcome Measures

Primary Outcomes (1)

• Average number of commission errors

  Average number of commission errors to the virtual reality task

  From one day to 8 weeks after day 0

Secondary Outcomes (21)

• Average reaction time (ms)

  From one day to 8 weeks after day 0

• Average number of omission errors

  From one day to 8 weeks after day 0

• Average number of head movement

  From one day to 8 weeks after day 0

• Average number of foot movement

  From one day to 8 weeks after day 0

• Percentage

  From one day to 8 weeks after day 0

Study Arms (2)

Attention Deficit Hyperactivity Disorder (ADHD)

EXPERIMENTAL

Children aged 8 to 12 diagnosed with ADHD

Procedure: Virtual reality task

Control

SHAM COMPARATOR

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

Procedure: Virtual reality task

Interventions

Virtual reality task 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.

Attention Deficit Hyperactivity Disorder (ADHD); Control

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

CHU de Bordeaux

Bordeaux, 33 076, France

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Jean-Arthur MICOULAUD-FRANCHI

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2020
• First Posted: September 24, 2020
• Study Start: July 21, 2020
• Primary Completion: May 4, 2022
• Study Completion: May 5, 2022
• Last Updated: July 24, 2025

Record last verified: 2025-07

Locations

FR (1)