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

Overview

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

Full Title of Study: “Development of a Virtual Reality Application for the Diagnosis of Childhood ADHD: an Exploratory Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 21, 2023

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

Interventions

  • Procedure: 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.

Arms, Groups and Cohorts

  • Experimental: Attention Deficit Hyperactivity Disorder (ADHD)
    • Children aged 8 to 12 diagnosed with ADHD
  • Sham Comparator: Control
    • Control group of healthy ADHD children matched in age, gender and laterality to children in ADHD group

Clinical Trial Outcome Measures

Primary Measures

  • Average number of commission errors
    • Time Frame: From one day to 8 weeks after day 0
    • Average number of commission errors to the virtual reality task

Secondary Measures

  • Average reaction time (ms)
    • Time Frame: From one day to 8 weeks after day 0
    • The average reaction time (ms) to the virtual reality task
  • Average number of omission errors
    • Time Frame: From one day to 8 weeks after day 0
    • Average number of omission errors to the virtual reality task
  • Average number of head movement
    • Time Frame: From one day to 8 weeks after day 0
    • The average amount of head movement to the virtual reality task
  • Average number of foot movement
    • Time Frame: From one day to 8 weeks after day 0
    • The average amount of foot movement to the virtual reality task
  • Percentage
    • Time Frame: From one day to 8 weeks after day 0
    • The percentage of periods with emotions during the virtual reality task
  • Percentage of period with presence of Emotion
    • Time Frame: From one day to 8 weeks after day 0
    • Percentage of period with presence of Emotion (Engagement > 50) during the task of virtual reality (range from 0 to 100).
  • Mean Emotion intensity (Engagement)
    • Time Frame: From one day to 8 weeks after day 0
    • Mean Emotion intensity (Engagement) during the task of virtual reality (range from 0 to 100).
  • Mean Emotion valence
    • Time Frame: From one day to 8 weeks after day 0
    • Mean Emotion valence (negative or positive emotion) during the task of virtual reality (range from -100 to 100).
  • Average reaction time (ms)
    • Time Frame: Day 0
    • The average reaction time (ms) to the Continuous Performance Test (CPT) wich is a neuropsychological assessment test of sustained attention
  • Average number of commission errors
    • Time Frame: Day 0
    • The average number of commission errors to the CPT neuropsychological task
  • Average number of omission errors
    • Time Frame: Day 0
    • The average number of omission errors to the CPT neuropsychological task
  • Total score with the Attention-Deficit Hyperactivity Disorder-Rating Scale.
    • Time Frame: Day 0
    • Scale to assess the severity of the 18 symptoms of DSM related to ADHD, the higher score mean a worse outcome. Max value : 54
  • Inattention score with the Attention-Deficit Hyperactivity Disorder-Rating Scale
    • Time Frame: Day 0
    • Inattention score with the Attention-Deficit Hyperactivity Disorder-Rating Scale. With inattention (items impairs) max value = 27, the higher score mean a worse outcome
  • Hyperactivity score with the Attention-Deficit Hyperactivity Disorder-Rating Scale
    • Time Frame: Day 0
    • Hyperactivity score with the Attention-Deficit Hyperactivity Disorder-Rating Scale. Hyperactivity (items pairs) max value=27, the higher score mean a worse outcome
  • Executive Performance Inventory Score
    • Time Frame: Day 0
    • Executive Performance Inventory Score with Behavior Rating Inventory of Executive Function (BRIEF) questionnaire. Min value=30 and max value=100 the higher score mean a worse outcome.
  • Quality of life (VSPA-e) score
    • Time Frame: Day 0
    • Quality of life score with VSPA-e questionnaire. Min value= 0 and max value=100 the higher score mean a worse outcome
  • Quality of life (KIDSCREEN) score
    • Time Frame: Day 0
    • Quality of life with KIDSCREEN questionnaire. Min value= 0 and max value=100 the higher score mean a better outcome.
  • Acceptability score of virtual reality tool
    • Time Frame: From one day to 8 weeks after day 0
    • Acceptability score of virtual reality tool. Min value= 6 and max value=30 the higher score mean a better outcome.
  • Acceptability score of classic neuropsychological test
    • Time Frame: From one day to 8 weeks after day 0
    • Acceptability score of classic neuropsychological test. Min value= 6 and max value=30 the higher score mean a better outcome.
  • Simulator Sickness score
    • Time Frame: From one day to 8 weeks after day 0
    • Score on the “Simulator Sickness” questionnaire. Min value= 0 and max value=63 the higher score mean a worse outcome.
  • Feeling of presence score
    • Time Frame: From one day to 8 weeks after day 0
    • Score at the “feeling of presence” scale. Min value= -42 and max value=+42 The higher score mean a better immersion.

Participating in This Clinical Trial

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 – Na├»ve 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

Gender Eligibility: All

Minimum Age: 8 Years

Maximum Age: 12 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University Hospital, Bordeaux
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jean-Arthur MICOULAUD-FRANCHI, Principal Investigator, University Hospital, Bordeaux
  • Overall Contact(s)
    • Jean-Arthur MICOULAUD-FRANCHI, 05 57 82 11 59, jean-arthur.micoulaud-franchi@chu-bordeaux.fr

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