ADHDNewNCT04337905
Virtual Reality (VR) Diagnostic Tool for Attention Deficits/Hyperactivity Disorder (ADHD)
A study testing ADHD-VR diagnosis tool in people with ADHD and Executive Dysfunction, run by Tjhin Wiguna at 1 site in Indonesia.
Trial summary
Attention deficit/ hyperactivity disorder (ADHD) is a common neurodevelopmental disorder. The common diagnostic of ADHD is based on psychiatric examination and interview. So far, there is not any other diagnostic tool for ADHD nowadays. Read more about this study
- Who is it for?
- Ages 6 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- ADHD, Executive Dysfunction
- What is being tested?
- ADHD-VR diagnosis tool
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIndonesia
- Study dates
- 25 May 2019to 31 Jul 2021
- 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 6 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children with ADHD drug naive
- Parent willing to participate in the study by signing informed consent
- Children willing to participate the ADHD-VR diagnostic tool for at least 30 minutes
- Do not have any mental disorder
- Do not have untreated chronic physical illnesses
- Parent willing to participate in the study by signing informed consent
- Children willing to participate the ADHD-VR diagnostic tool for at least 30 minutes
Who cannot join
- Having untreated chronic physical illnesses
- Having other mental disorders except ADHD
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
dr. Cipto Mangunkusumo General Hospital
Jakarta Pusat, DKI Jakarta, 10430
About this study
Official title: A New Development Diagnostic Tool for ADHD: A VR Approach
Attention deficit/ hyperactivity disorder (ADHD) is a common neurodevelopmental disorder. The common diagnostic of ADHD is based on psychiatric examination and interview. So far, there is not any other diagnostic tool for ADHD nowadays. Therefore, virtual reality (VR) technology can be used as a stimulus, replacing real stimuli, recreating experiences, which are in the real world would be impossible. Consequently, ADHD-VR diagnostic tool development should be started to justify the ADHD diagnosis in psychiatric out-patient clinical services.
Read the detailed description
Diagnostic test is a very essential in modern medical practices, especially in child and adolescent psychiatry field because the main diagnostic tool is only based on psychiatry interview and observation. Using Diagnostic tool can help a confirmation towards specific clinical diagnosis, provide more evidence for eliminating one diagnosis versus another, provide more evidence for parents, or to rule out the differential diagnosis. Even though psychiatric examination is the main approach on ADHD diagnostic procedure, however the laboratory testing or imaging examination is also used especially to rule out the general medical condition or to find out any medical conditions that mimic ADHD but not to facilitate the ADHD diagnosis per se. Nowadays, the expand study in biological psychiatry has found a lot of biological markers in ADHD as well; but none is really sensitive and specific for ADHD diagnostic test. Therefore, there should be another approach for developing diagnostic tool in ADHD. VR is one of the best approach bacasue these days, because VR as an ADHD diagnostic tool could create and replace real stimuli, recreating experiences, which could not be observed by the clinician at the out-patient clinic.
- Conditions
- ADHD, Executive Dysfunction
- Being tested
- ADHD-VR diagnosis tool
- Keywords
- ADHD, virtual reality,, diagnostic tool, neuropsychological test, Indonesia
- 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.
ADHD-VR diagnosis toolDevice
Since that time and in accordance with the application area, several definitions have been formulated: for example, Fuchs and Bishop (1992) defined VR as "real-time interactive graphics with 3D models, combined with a display technology that gives the user the immersion in the model world and direct manipulation"; Gigante (1993) described VR as "The illusion of participation in a synthetic environment rather than external observation of such an environment. VR relies on a 3D, stereoscopic head-tracker displays, hand/body tracking and binaural sound. VR is an immersive, multi-sensory experience"; and "Virtual reality refers to immersive, interactive, multi-sensory, viewer-centered, 3D computer generated environments and the combination of technologies required building environments".
| Study group | Role | What they receive |
|---|---|---|
| Children with ADHD | Experimental | Children with ADHD that running the ADHD-VR diagnostic test and also did the psychiatric examination to determine the ADHD diagnosis and to rule out other mental disorders Receives: Device: ADHD-VR diagnosis tool |
| Children without ADHD | Active comparator | Healthy children that also running the ADHD-VR diagnostic test and also psyhchiatric examination to rule out the ADHD diagnosis and other mental disorders Receives: Device: ADHD-VR diagnosis tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
The sensitivity and specificity of ADHD-VR diagnostic tool towards ADHD clinical symptoms
The comparing between the ADHD-VR diagnostic test results and expert judgement on ADHD diagnosis
Measured: up to 30 minutes
The sensitivity and specificity of ADHD-VR diagnostic tool towards executive function
Comparing between the ADHD-VR diagnostic test results and Behavior Rating Inventory for Executive Function Rating Scale.
Measured: up to 30 minues
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2020
- Study start25 May 2019
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies of the same condition, open and under way.
- 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
- Model description
- There is two group of children: 1. Group 1: Children with ADHD 2. Group 2: Children without ADHD as a control group Both group will running the ADHD-VR diagnostic test and goes to diagnosis by child psychiatrist. The outcomes that were analyzed: 1. The sensitivity, specificity and Likelihood ratio of the ADHD-VR diagnostic test in detecting the ADHD clinical symptoms and executive function 2. Content validity of the ADHD-VR diagnostic test
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tjhin Wiguna
- Sponsor type
- University, hospital or other
- Collaborators
- Fakultas Kedokteran Universitas Indonesia, Dr Cipto Mangunkusumo General Hospital, Binus University International
- Responsible party
- Sponsor-investigator, Tjhin Wiguna, Dr Cipto Mangunkusumo General Hospital
- Investigators
- Tjhin Wiguna, PhD, Principal investigator, Dr Cipto Mangunkusumo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04337905
- Sponsor's protocol ID
- ADHD-VR
- Acronym
- New
- Status last verified
- Apr 2020
- First submitted
- 3 Apr 2020
- Last updated
- 8 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No decided yet
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Development Diagnostic Tool for ADHD: A VR Approach
- ClinicalTrials.gov ID
- NCT04337905
- Acronym / sponsor ID
- New / ADHD-VR
- Conditions
- ADHD, Executive Dysfunction
- Keywords
- ADHD, virtual reality,, diagnostic tool, neuropsychological test, Indonesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tjhin WigunaUniversity, hospital or other
- Collaborators
- Fakultas Kedokteran Universitas Indonesia, Dr Cipto Mangunkusumo General Hospital, Binus University International
- Study start
- 25 May 2019 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Jul 2021 (estimated)
- First posted
- 8 Apr 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.
Attention deficit/ hyperactivity disorder (ADHD) is a common neurodevelopmental disorder. The common diagnostic of ADHD is based on psychiatric examination and interview. So far, there is not any other diagnostic tool for ADHD nowadays. Therefore, virtual reality (VR) technology can be used as a stimulus, replacing real stimuli, recreating experiences, which are in the real world would be impossible. Consequently, ADHD-VR diagnostic tool development should be started to justify the ADHD diagnosis in psychiatric out-patient clinical services.
Detailed description
Diagnostic test is a very essential in modern medical practices, especially in child and adolescent psychiatry field because the main diagnostic tool is only based on psychiatry interview and observation. Using Diagnostic tool can help a confirmation towards specific clinical diagnosis, provide more evidence for eliminating one diagnosis versus another, provide more evidence for parents, or to rule out the differential diagnosis. Even though psychiatric examination is the main approach on ADHD diagnostic procedure, however the laboratory testing or imaging examination is also used especially to rule out the general medical condition or to find out any medical conditions that mimic ADHD but not to facilitate the ADHD diagnosis per se. Nowadays, the expand study in biological psychiatry has found a lot of biological markers in ADHD as well; but none is really sensitive and specific for ADHD diagnostic test. Therefore, there should be another approach for developing diagnostic tool in ADHD. VR is one of the best approach bacasue these days, because VR as an ADHD diagnostic tool could create and replace real stimuli, recreating experiences, which could not be observed by the clinician at the out-patient clinic.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- There is two group of children: 1. Group 1: Children with ADHD 2. Group 2: Children without ADHD as a control group Both group will running the ADHD-VR diagnostic test and goes to diagnosis by child psychiatrist. The outcomes that were analyzed: 1. The sensitivity, specificity and Likelihood ratio of the ADHD-VR diagnostic test in detecting the ADHD clinical symptoms and executive function 2. Content validity of the ADHD-VR diagnostic test
| Arm | Type | Receives |
|---|---|---|
| Children with ADHD | Experimental | Device: ADHD-VR diagnosis toolChildren with ADHD that running the ADHD-VR diagnostic test and also did the psychiatric examination to determine the ADHD diagnosis and to rule out other mental disorders |
| Children without ADHD | Active comparator | Device: ADHD-VR diagnosis toolHealthy children that also running the ADHD-VR diagnostic test and also psyhchiatric examination to rule out the ADHD diagnosis and other mental disorders |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Children with ADHD drug naive
- Parent willing to participate in the study by signing informed consent
- Children willing to participate the ADHD-VR diagnostic tool for at least 30 minutes
- Do not have any mental disorder
- Do not have untreated chronic physical illnesses
Key exclusion criteria (2 listed)
- Having untreated chronic physical illnesses
- Having other mental disorders except ADHD
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 |
|---|---|---|
| ADHD-VR diagnosis toolSince that time and in accordance with the application area, several definitions have been formulated: for example, Fuchs and Bishop (1992) defined VR as "real-time interactive graphics with 3D models, combined with a display technology that gives the user the immersion in the model world and direct manipulation"; Gigante (1993) described VR as "The illusion of participation in a synthetic environment rather than external observation of such an environment. VR relies on a 3D, stereoscopic head-tracker displays, hand/body tracking and binaural sound. VR is an immersive, multi-sensory experience"; and "Virtual reality refers to immersive, interactive, multi-sensory, viewer-centered, 3D computer generated environments and the combination of technologies required building environments". | Device | Children with ADHD, Children without ADHD |
Primary outcome
The sensitivity and specificity of ADHD-VR diagnostic tool towards ADHD clinical symptoms
Time frame: up to 30 minutes
The comparing between the ADHD-VR diagnostic test results and expert judgement on ADHD diagnosis
The sensitivity and specificity of ADHD-VR diagnostic tool towards executive function
Time frame: up to 30 minues
Comparing between the ADHD-VR diagnostic test results and Behavior Rating Inventory for Executive Function Rating Scale.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2020.
- Individual participant dataSharing planned: No. No decided yet
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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.
Tjhin Wiguna, PhD principal investigator
Dr Cipto Mangunkusumo General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ADHD-VR diagnosis tool in people with ADHD and Executive Dysfunction, run by Tjhin Wiguna at 1 site in Indonesia.
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 7 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 8 Apr 2020. 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 Indonesia. 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. 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?
Results are not available in the source record.
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?
The sensitivity and specificity of ADHD-VR diagnostic tool towards ADHD clinical symptoms (time frame: up to 30 minutes). The study lists 2 primary outcomes in all. 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 8 Apr 2020.