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

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

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

Study Overview

• Status: Recruiting
• Conditions: Attention Deficit Hyperactivity Disorder
• Intervention / Treatment: Procedure: Virtual reality task

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

• Study Type: Interventional
• Enrollment (Anticipated): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jean-Arthur MICOULAUD-FRANCHI; Phone Number: 05 57 82 11 59; Email: jean-arthur.micoulaud-franchi@chu-bordeaux.fr
• Study Contact Backup: Name: Cécile KLOCHENDLER; Phone Number: 05 57 82 11 59; Email: cecile.klochendler@chu-bordeaux.fr

Study Locations

• France
  • Bordeaux, France, 33 076
    • Recruiting
    • CHU de Bordeaux
    • Contact: Cécile KLOCHENDLER; Phone Number: 05 57 82 11 59; Email: cecile.klochendler@chu-bordeaux.fr
    • Contact: Jean-Arthur MICOULAUD-FRANCHI; Phone Number: 05 57 82 16 97; Email: jean-arthur.micoulaud-franchi@chu-bordeaux.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 12 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Attention Deficit Hyperactivity Disorder (ADHD); Children aged 8 to 12 diagnosed with ADHD	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.
Sham Comparator: Control; Control group of healthy ADHD children matched in age, gender and laterality to children in ADHD group	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.

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

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Investigators: Principal Investigator: Jean-Arthur MICOULAUD-FRANCHI, University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2020
• Primary Completion (Anticipated): March 21, 2023
• Study Completion (Anticipated): March 21, 2023

Study Registration Dates

• First Submitted: August 3, 2020
• First Submitted That Met QC Criteria: September 19, 2020
• First Posted (Actual): September 24, 2020

Study Record Updates

• Last Update Posted (Actual): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 30, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Attention Deficit Hyperactivity Disorder; Virtual reality
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity; Hyperkinesis
• Other Study ID Numbers: 2018/33

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No