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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-A02603-54 | Other Identifier | ANSM |
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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Attention Deficit Hyperactivity Disorder (ADHD) | Experimental | Children aged 8 to 12 diagnosed with ADHD |
|
| Control | Sham Comparator | Control group of healthy ADHD children matched in age, gender and laterality to children in ADHD group |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Group of children with ADHD :
Children aged 8 to 12 years undiagnosed ADHD (according to DSM-V criteria) :
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Arthur MICOULAUD-FRANCHI | University Hospital, Bordeaux | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Bordeaux | Bordeaux | 33 076 | France |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| 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 |