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Virtual Reality (VR) Diagnostic Tool for Attention Deficits/Hyperactivity Disorder (ADHD) (New)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04337905
Recruitment Status : Enrolling by invitation
First Posted : April 8, 2020
Last Update Posted : April 8, 2020
Sponsor:
Collaborators:
Fakultas Kedokteran Universitas Indonesia
Dr Cipto Mangunkusumo General Hospital
Binus University International
Information provided by (Responsible Party):
Tjhin Wiguna, Dr Cipto Mangunkusumo General Hospital

Brief 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. 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.

Condition or disease Intervention/treatment Phase
ADHD Executive Dysfunction Device: ADHD-VR diagnosis tool Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Care Provider, Investigator, Outcomes Assessor)
Masking Description: The investigator blind to the ADHD-VR diagnostic test results The care provider blind to the ADHD-VR diagnostic test results The ADHD-VR assessor blind to the ADHD diagnosis
Primary Purpose: Diagnostic
Official Title: A New Development Diagnostic Tool for ADHD: A VR Approach
Actual Study Start Date : May 25, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : July 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Children with ADHD
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
Device: ADHD-VR diagnosis tool
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".

Active Comparator: Children without ADHD
Healthy children that also running the ADHD-VR diagnostic test and also psyhchiatric examination to rule out the ADHD diagnosis and other mental disorders
Device: ADHD-VR diagnosis tool
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".




Primary Outcome Measures :
  1. 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

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria for ADHD group:

  • 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

Exclusion Criteria:

  • Having untreated chronic physical illnesses
  • Having other mental disorders except ADHD

Inclusion Criteria for healthy children group:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04337905


Locations
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Indonesia
dr. Cipto Mangunkusumo General Hospital
Jakarta Pusat, DKI Jakarta, Indonesia, 10430
Sponsors and Collaborators
Tjhin Wiguna
Fakultas Kedokteran Universitas Indonesia
Dr Cipto Mangunkusumo General Hospital
Binus University International
Investigators
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Principal Investigator: Tjhin Wiguna, PhD Dr Cipto Mangunkusumo General Hospital
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Responsible Party: Tjhin Wiguna, Prof. Dr. dr., Dr Cipto Mangunkusumo General Hospital
ClinicalTrials.gov Identifier: NCT04337905    
Other Study ID Numbers: ADHD-VR
First Posted: April 8, 2020    Key Record Dates
Last Update Posted: April 8, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No decided yet

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tjhin Wiguna, Dr Cipto Mangunkusumo General Hospital:
ADHD
virtual reality,
diagnostic tool
neuropsychological test
Indonesia