Clinical trial NCT04561713: Virtual Reality and Diagnostic of Attention Deficit Hyperactivity Disorder (ADHD) (PADA1)
Official title: Development of a Virtual Reality Application for the Diagnosis of Childhood ADHD: an Exploratory Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: Attention Deficit Hyperactivity Disorder
Virtual reality
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2020-09-24
Enrollment: 42
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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

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

Primary outcomes:
measure: Average number of commission errors
timeFrame: From one day to 8 weeks after day 0
Secondary outcomes:
measure: Average reaction time (ms)
timeFrame: From one day to 8 weeks after day 0
measure: Average number of omission errors
timeFrame: From one day to 8 weeks after day 0
measure: Average number of head movement
timeFrame: From one day to 8 weeks after day 0
measure: Average number of foot movement
timeFrame: From one day to 8 weeks after day 0
measure: Percentage
timeFrame: From one day to 8 weeks after day 0
measure: Percentage of period with presence of Emotion
timeFrame: From one day to 8 weeks after day 0
measure: Mean Emotion intensity (Engagement)
timeFrame: From one day to 8 weeks after day 0
measure: Mean Emotion valence
timeFrame: From one day to 8 weeks after day 0
measure: Average reaction time (ms)
timeFrame: Day 0
measure: Average number of commission errors
timeFrame: Day 0
measure: Average number of omission errors
timeFrame: Day 0
measure: Total score with the Attention-Deficit Hyperactivity Disorder-Rating Scale.
timeFrame: Day 0
measure: Inattention score with the Attention-Deficit Hyperactivity Disorder-Rating Scale
timeFrame: Day 0
measure: Hyperactivity score with the Attention-Deficit Hyperactivity Disorder-Rating Scale
timeFrame: Day 0
measure: Executive Performance Inventory Score
timeFrame: Day 0
measure: Quality of life (VSPA-e) score
timeFrame: Day 0
measure: Quality of life (KIDSCREEN) score
timeFrame: Day 0
measure: Acceptability score of virtual reality tool
timeFrame: From one day to 8 weeks after day 0
measure: Acceptability score of classic neuropsychological test
timeFrame: From one day to 8 weeks after day 0
measure: Simulator Sickness score
timeFrame: From one day to 8 weeks after day 0
measure: Feeling of presence score
timeFrame: From one day to 8 weeks after day 0
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux
Study officials:
affiliation: University Hospital, Bordeaux
name: Jean-Arthur MICOULAUD-FRANCHI
role: PRINCIPAL_INVESTIGATOR
References: