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

Attention Deficit Hyperactivity Disorder Clinical Trial

— PADA1  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04561713
• Other study ID #: 2018/33
• Status: Recruiting
• Phase: N/A
• Start date: July 21, 2020
• Est. completion date: March 21, 2023

Study information

• Verified date: March 2022
• Source: University Hospital, Bordeaux
• Contact: Jean-Arthur MICOULAUD-FRANCHI
• Phone: 05 57 82 11 59
• Email: jean-arthur.micoulaud-franchi[@]chu-bordeaux.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: March 21, 2023
• Est. primary completion date: March 21, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

Intervention

Procedure:
• Virtual reality task
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.

Locations

Country	Name	City	State
France	CHU de Bordeaux	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Average reaction time (ms)	The average reaction time (ms) to the virtual reality task	From one day to 8 weeks after day 0
Secondary	Average number of omission errors	Average number of omission errors to the virtual reality task	From one day to 8 weeks after day 0
Secondary	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
Secondary	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
Secondary	Percentage	The percentage of periods with emotions during the virtual reality task	From one day to 8 weeks after day 0
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Average number of commission errors	The average number of commission errors to the CPT neuropsychological task	Day 0
Secondary	Average number of omission errors	The average number of omission errors to the CPT neuropsychological task	Day 0
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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