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Completed

NCT Number: NCT04561713

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

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

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Key information

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Bordeaux

Bordeaux, 33 076, France

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. Percentage

    Time frame: From one day to 8 weeks after day 0

    The percentage of periods with emotions during the virtual reality task

  6. 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).

  7. 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).

  8. 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).

  9. 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

  10. Average number of commission errors

    Time frame: Day 0

    The average number of commission errors to the CPT neuropsychological task

  11. Average number of omission errors

    Time frame: Day 0

    The average number of omission errors to the CPT neuropsychological task

  12. 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

  13. 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

  14. 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

  15. 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.

  16. 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

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

Development of a Virtual Reality Application for the Diagnosis of Childhood ADHD: an Exploratory Study

Acronym: PADA1

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Sep 24, 2020
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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