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

• ClinicalTrials.gov Identifier: NCT04337905
• Recruitment Status: Enrolling by invitation
• First Posted: April 8, 2020
• Last Update Posted: April 8, 2020
• Sponsor: Tjhin Wiguna
• 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

Study Description

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.

Study Design

• 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

Arms and Interventions

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".

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Locations

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

• Principal Investigator: Tjhin Wiguna, PhD; Dr Cipto Mangunkusumo General Hospital

More Information

• 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
• 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

• 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