CHU de Bordeaux
Bordeaux, 33 076, France
NCT Number: NCT04561713
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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Notify Me8 year–12 year
All sexes
Interventional
Not applicable
Bordeaux, 33 076, France
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
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 years undiagnosed ADHD (according to DSM-V criteria) :
Exclusion criteria
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.
Time frame: From one day to 8 weeks after day 0
Average number of commission errors to the virtual reality task
Time frame: From one day to 8 weeks after day 0
The average reaction time (ms) to the virtual reality task
Time frame: From one day to 8 weeks after day 0
Average number of omission errors to the virtual reality task
Time frame: From one day to 8 weeks after day 0
The average amount of head movement to the virtual reality task
Time frame: From one day to 8 weeks after day 0
The average amount of foot movement to the virtual reality task
Time frame: From one day to 8 weeks after day 0
The percentage of periods with emotions during the virtual reality task
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).
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).
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).
Time frame: Day 0
The average reaction time (ms) to the Continuous Performance Test (CPT) wich is a neuropsychological assessment test of sustained attention
Time frame: Day 0
The average number of commission errors to the CPT neuropsychological task
Time frame: Day 0
The average number of omission errors to the CPT neuropsychological task
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
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
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
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.
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
Time frame: Day 0
Quality of life with KIDSCREEN questionnaire. Min value= 0 and max value=100 the higher score mean a better outcome.
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.
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.
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.
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.
University Hospital, Bordeaux
Other
Development of a Virtual Reality Application for the Diagnosis of Childhood ADHD: an Exploratory Study
Acronym: PADA1
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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