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

ADHD Clinical Trial

— New  

Official title:

A New Development Diagnostic Tool for ADHD: A VR Approach

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04337905
• Other study ID #: ADHD-VR
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 25, 2019
• Est. completion date: July 31, 2021

Study information

• Verified date: April 2020
• Source: Dr Cipto Mangunkusumo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: July 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• ADHD
• Executive Dysfunction

Intervention

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".

Locations

Country	Name	City	State
Indonesia	dr. Cipto Mangunkusumo General Hospital	Jakarta Pusat	DKI Jakarta

Sponsors (4)

Lead Sponsor	Collaborator
Tjhin Wiguna	Binus University International, Dr Cipto Mangunkusumo General Hospital, Fakultas Kedokteran Universitas Indonesia

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	up to 30 minutes
Primary	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.	up to 30 minues