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

May 19, 2026 updated by: University Hospital, Bordeaux

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Bordeaux, France, 33 076
        • CHU de Bordeaux

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

8 years to 12 years (Child)

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Average number of commission errors
Time Frame: From one day to 8 weeks after day 0
Average number of commission errors to the virtual reality task
From one day to 8 weeks after day 0

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Average reaction time (ms)
Time Frame: From one day to 8 weeks after day 0
The average reaction time (ms) to the virtual reality task
From one day to 8 weeks after day 0
Average number of omission errors
Time Frame: From one day to 8 weeks after day 0
Average number of omission errors to the virtual reality task
From one day to 8 weeks after day 0
Average number of head movement
Time Frame: From one day to 8 weeks after day 0
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
Time Frame: From one day to 8 weeks after day 0
The average amount of foot movement to the virtual reality task
From one day to 8 weeks after day 0
Percentage
Time Frame: From one day to 8 weeks after day 0
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
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).
From one day to 8 weeks after day 0
Mean Emotion intensity (Engagement)
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).
From one day to 8 weeks after day 0
Mean Emotion valence
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).
From one day to 8 weeks after day 0
Average reaction time (ms)
Time Frame: Day 0
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
Time Frame: Day 0
The average number of commission errors to the CPT neuropsychological task
Day 0
Average number of omission errors
Time Frame: Day 0
The average number of omission errors to the CPT neuropsychological task
Day 0
Total score with the Attention-Deficit Hyperactivity Disorder-Rating Scale.
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
Day 0
Inattention score with the Attention-Deficit Hyperactivity Disorder-Rating Scale
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
Day 0
Hyperactivity score with the Attention-Deficit Hyperactivity Disorder-Rating Scale
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
Day 0
Executive Performance Inventory Score
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.
Day 0
Quality of life (VSPA-e) score
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
Day 0
Quality of life (KIDSCREEN) score
Time Frame: Day 0
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
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.
From one day to 8 weeks after day 0
Acceptability score of classic neuropsychological test
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.
From one day to 8 weeks after day 0
Simulator Sickness score
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.
From one day to 8 weeks after day 0
Feeling of presence score
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.
From one day to 8 weeks after day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Bordeaux

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jean-Arthur MICOULAUD-FRANCHI, University Hospital, Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 21, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 4, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 5, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 3, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 19, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 24, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2018/33
  • 2019-A02603-54 (Other Identifier: ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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