Attention Deficit Hyperactivity DisorderPADA1NCT04561713
Virtual Reality and Diagnostic of Attention Deficit Hyperactivity Disorder (ADHD) (PADA1)
A study testing Virtual reality task in people with Attention Deficit Hyperactivity Disorder, run by University Hospital, Bordeaux at 1 site in France.
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 Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Virtual reality task
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 21 Jul 2020to 5 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Virtual reality task
- Keywords
- Attention Deficit Hyperactivity Disorder, Virtual reality
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality taskProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Attention Deficit Hyperactivity Disorder (ADHD) | Experimental | Children aged 8 to 12 diagnosed with ADHD Receives: Procedure: Virtual reality task |
| Control | Sham comparator | Control group of healthy ADHD children matched in age, gender and laterality to children in ADHD group Receives: Procedure: Virtual reality task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average number of commission errors
Average number of commission errors to the virtual reality task
Measured: From one day to 8 weeks after day 0
Secondary outcomes (21)
Average reaction time (ms)
The average reaction time (ms) to the virtual reality task
Measured: From one day to 8 weeks after day 0
Average number of omission errors
Average number of omission errors to the virtual reality task
Measured: 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
Measured: 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
Measured: From one day to 8 weeks after day 0
Percentage
The percentage of periods with emotions during the virtual reality task
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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
Measured: Day 0
Average number of commission errors
The average number of commission errors to the CPT neuropsychological task
Measured: Day 0
Average number of omission errors
The average number of omission errors to the CPT neuropsychological task
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From one day to 8 weeks after day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study start21 Jul 2020
- Primary completion4 May 2022
- Study completion5 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Arthur MICOULAUD-FRANCHI, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04561713
- Sponsor's protocol ID
- 2018/33
- Other IDs
- 2019-A02603-54
- Acronym
- PADA1
- Status last verified
- Jul 2025
- First submitted
- 3 Aug 2020
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Virtual Reality Application for the Diagnosis of Childhood ADHD: an Exploratory Study
- ClinicalTrials.gov ID
- NCT04561713
- Acronym / sponsor ID
- PADA1 / 2018/33
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- Attention Deficit Hyperactivity Disorder, Virtual reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 21 Jul 2020 (actual)
- Primary completion
- 4 May 2022 (actual)
- Study completion
- 5 May 2022 (actual)
- First posted
- 24 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Attention Deficit Hyperactivity Disorder (ADHD) | Experimental | Procedure: Virtual reality taskChildren aged 8 to 12 diagnosed with ADHD |
| Control | Sham comparator | Procedure: Virtual reality taskControl group of healthy ADHD children matched in age, gender and laterality to children in ADHD group |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (16 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual reality taskVirtual 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. | Procedure or surgery | Attention Deficit Hyperactivity Disorder (ADHD), Control |
Primary outcome
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
21 secondary outcomes
Average reaction time (ms)
Time frame: 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 head movement
Time frame: 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
Percentage
Time frame: 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
Mean Emotion intensity (Engagement)
Time frame: From one day to 8 weeks after day 0
Mean Emotion valence
Time frame: From one day to 8 weeks after day 0
Average reaction time (ms)
Time frame: Day 0
Average number of commission errors
Time frame: Day 0
Average number of omission errors
Time frame: Day 0
Total score with the Attention-Deficit Hyperactivity Disorder-Rating Scale.
Time frame: Day 0
Inattention score with the Attention-Deficit Hyperactivity Disorder-Rating Scale
Time frame: Day 0
Hyperactivity score with the Attention-Deficit Hyperactivity Disorder-Rating Scale
Time frame: Day 0
Executive Performance Inventory Score
Time frame: Day 0
Quality of life (VSPA-e) score
Time frame: Day 0
Quality of life (KIDSCREEN) score
Time frame: Day 0
Acceptability score of virtual reality tool
Time frame: 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
Simulator Sickness score
Time frame: From one day to 8 weeks after day 0
Feeling of presence score
Time frame: From one day to 8 weeks after day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Arthur MICOULAUD-FRANCHI principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality task in people with Attention Deficit Hyperactivity Disorder, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average number of commission errors (time frame: From one day to 8 weeks after day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.