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

Study Overview
=================
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

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

Conditions
-----------------
Attention Deficit Hyperactivity Disorder

Intervention / Treatment
-----------------
* Procedure: Virtual reality task


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Attention Deficit Hyperactivity Disorder (ADHD)<br>Children aged 8 to 12 diagnosed with ADHD | Procedure: Virtual reality task<br>* 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.<br>|
| Sham Comparator: Control<br>Control group of healthy ADHD children matched in age, gender and laterality to children in ADHD group | Procedure: Virtual reality task<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Attention Deficit Hyperactivity Disorder, Virtual reality