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

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Virtual reality task
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Attention Deficit Hyperactivity Disorder focused on measuring Attention Deficit Hyperactivity Disorder, Virtual reality

Eligibility Criteria

8 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CHU de BordeauxRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Attention Deficit Hyperactivity Disorder (ADHD)

Control

Arm Description

Children aged 8 to 12 diagnosed with ADHD

Control group of healthy ADHD children matched in age, gender and laterality to children in ADHD group

Outcomes

Primary Outcome Measures

Average number of commission errors
Average number of commission errors to the virtual reality task

Secondary Outcome Measures

Average reaction time (ms)
The average reaction time (ms) to the virtual reality task
Average number of omission errors
Average number of omission errors to the virtual reality task
Average number of head movement
The average amount of head movement to the virtual reality task
Average number of foot movement
The average amount of foot movement to the virtual reality task
Percentage
The percentage of periods with emotions during the virtual reality task
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).
Mean Emotion intensity (Engagement)
Mean Emotion intensity (Engagement) during the task of virtual reality (range from 0 to 100).
Mean Emotion valence
Mean Emotion valence (negative or positive emotion) during the task of virtual reality (range from -100 to 100).
Average reaction time (ms)
The average reaction time (ms) to the Continuous Performance Test (CPT) wich is a neuropsychological assessment test of sustained attention
Average number of commission errors
The average number of commission errors to the CPT neuropsychological task
Average number of omission errors
The average number of omission errors to the CPT neuropsychological task
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
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
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
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.
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
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.
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.
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.
Simulator Sickness score
Score on the "Simulator Sickness" questionnaire. Min value= 0 and max value=63 the higher score mean a worse outcome.
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.

Full Information

First Posted
August 3, 2020
Last Updated
March 30, 2022
Sponsor
University Hospital, Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT04561713
Brief Title
Virtual Reality and Diagnostic of Attention Deficit Hyperactivity Disorder (ADHD) (PADA1)
Acronym
PADA1
Official Title
Development of a Virtual Reality Application for the Diagnosis of Childhood ADHD: an Exploratory Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 21, 2020 (Actual)
Primary Completion Date
March 21, 2023 (Anticipated)
Study Completion Date
March 21, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
Keywords
Attention Deficit Hyperactivity Disorder, Virtual reality

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Attention Deficit Hyperactivity Disorder (ADHD)
Arm Type
Experimental
Arm Description
Children aged 8 to 12 diagnosed with ADHD
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
Control group of healthy ADHD children matched in age, gender and laterality to children in ADHD group
Intervention Type
Procedure
Intervention Name(s)
Virtual reality task
Intervention Description
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.
Primary Outcome Measure Information:
Title
Average number of commission errors
Description
Average number of commission errors to the virtual reality task
Time Frame
From one day to 8 weeks after day 0
Secondary Outcome Measure Information:
Title
Average reaction time (ms)
Description
The average reaction time (ms) to the virtual reality task
Time Frame
From one day to 8 weeks after day 0
Title
Average number of omission errors
Description
Average number of omission errors to the virtual reality task
Time Frame
From one day to 8 weeks after day 0
Title
Average number of head movement
Description
The average amount of head movement to the virtual reality task
Time Frame
From one day to 8 weeks after day 0
Title
Average number of foot movement
Description
The average amount of foot movement to the virtual reality task
Time Frame
From one day to 8 weeks after day 0
Title
Percentage
Description
The percentage of periods with emotions during the virtual reality task
Time Frame
From one day to 8 weeks after day 0
Title
Percentage of period with presence of Emotion
Description
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
Title
Mean Emotion intensity (Engagement)
Description
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
Title
Mean Emotion valence
Description
Mean Emotion valence (negative or positive emotion) during the task of virtual reality (range from -100 to 100).
Time Frame
From one day to 8 weeks after day 0
Title
Average reaction time (ms)
Description
The average reaction time (ms) to the Continuous Performance Test (CPT) wich is a neuropsychological assessment test of sustained attention
Time Frame
Day 0
Title
Average number of commission errors
Description
The average number of commission errors to the CPT neuropsychological task
Time Frame
Day 0
Title
Average number of omission errors
Description
The average number of omission errors to the CPT neuropsychological task
Time Frame
Day 0
Title
Total score with the Attention-Deficit Hyperactivity Disorder-Rating Scale.
Description
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
Title
Inattention score with the Attention-Deficit Hyperactivity Disorder-Rating Scale
Description
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
Title
Hyperactivity score with the Attention-Deficit Hyperactivity Disorder-Rating Scale
Description
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
Title
Executive Performance Inventory Score
Description
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
Title
Quality of life (VSPA-e) score
Description
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
Title
Quality of life (KIDSCREEN) score
Description
Quality of life with KIDSCREEN questionnaire. Min value= 0 and max value=100 the higher score mean a better outcome.
Time Frame
Day 0
Title
Acceptability score of virtual reality tool
Description
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
Title
Acceptability score of classic neuropsychological test
Description
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
Title
Simulator Sickness score
Description
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
Title
Feeling of presence score
Description
Score at the "feeling of presence" scale. Min value= -42 and max value=+42 The higher score mean a better immersion.
Time Frame
From one day to 8 weeks after day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-Arthur MICOULAUD-FRANCHI
Phone
05 57 82 11 59
Email
jean-arthur.micoulaud-franchi@chu-bordeaux.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Cécile KLOCHENDLER
Phone
05 57 82 11 59
Email
cecile.klochendler@chu-bordeaux.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Arthur MICOULAUD-FRANCHI
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Bordeaux
City
Bordeaux
ZIP/Postal Code
33 076
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Arthur MICOULAUD-FRANCHI
Phone
05 57 82 16 97
Email
jean-arthur.micoulaud-franchi@chu-bordeaux.fr
First Name & Middle Initial & Last Name & Degree
Cécile KLOCHENDLER
Phone
05 57 82 11 59
Email
cecile.klochendler@chu-bordeaux.fr

12. IPD Sharing Statement

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

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