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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04561713
Acronym
PADA1
Enrollment
30
Registered
2020-09-24
Start date
2020-07-21
Completion date
2022-05-05
Last updated
2025-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

Attention Deficit Hyperactivity Disorder, Virtual reality

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

Interventions

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.

Sponsors

University Hospital, Bordeaux
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
8 Years to 12 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Average number of commission errorsFrom one day to 8 weeks after day 0Average number of commission errors to the virtual reality task

Secondary

MeasureTime frameDescription
Average number of omission errorsFrom one day to 8 weeks after day 0Average number of omission errors to the virtual reality task
Average number of head movementFrom one day to 8 weeks after day 0The average amount of head movement to the virtual reality task
Average number of foot movementFrom one day to 8 weeks after day 0The average amount of foot movement to the virtual reality task
PercentageFrom one day to 8 weeks after day 0The percentage of periods with emotions during the virtual reality task
Percentage of period with presence of EmotionFrom one day to 8 weeks after day 0Percentage of period with presence of Emotion (Engagement \> 50) during the task of virtual reality (range from 0 to 100).
Mean Emotion intensity (Engagement)From one day to 8 weeks after day 0Mean Emotion intensity (Engagement) during the task of virtual reality (range from 0 to 100).
Mean Emotion valenceFrom one day to 8 weeks after day 0Mean Emotion valence (negative or positive emotion) during the task of virtual reality (range from -100 to 100).
Average number of commission errorsDay 0The average number of commission errors to the CPT neuropsychological task
Total score with the Attention-Deficit Hyperactivity Disorder-Rating Scale.Day 0Scale to assess the severity of the 18 symptoms of DSM related to ADHD, the higher score mean a worse outcome. Max value : 54
Average reaction time (ms)From one day to 8 weeks after day 0The average reaction time (ms) to the virtual reality task
Hyperactivity score with the Attention-Deficit Hyperactivity Disorder-Rating ScaleDay 0Hyperactivity 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 ScoreDay 0Executive 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) scoreDay 0Quality 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) scoreDay 0Quality of life with KIDSCREEN questionnaire. Min value= 0 and max value=100 the higher score mean a better outcome.
Acceptability score of virtual reality toolFrom one day to 8 weeks after day 0Acceptability score of virtual reality tool. Min value= 6 and max value=30 the higher score mean a better outcome.
Acceptability score of classic neuropsychological testFrom one day to 8 weeks after day 0Acceptability score of classic neuropsychological test. Min value= 6 and max value=30 the higher score mean a better outcome.
Simulator Sickness scoreFrom one day to 8 weeks after day 0Score on the Simulator Sickness questionnaire. Min value= 0 and max value=63 the higher score mean a worse outcome.
Feeling of presence scoreFrom one day to 8 weeks after day 0Score at the feeling of presence scale. Min value= -42 and max value=+42 The higher score mean a better immersion.
Inattention score with the Attention-Deficit Hyperactivity Disorder-Rating ScaleDay 0Inattention score with the Attention-Deficit Hyperactivity Disorder-Rating Scale. With inattention (items impairs) max value = 27, the higher score mean a worse outcome

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026