Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2025-12-26 @ 1:49 AM
Study NCT ID:
NCT04337905
Status:
UNKNOWN
Last Update Posted:
2020-04-08
First Post:
2020-04-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Virtual Reality (VR) Diagnostic Tool for Attention Deficits/Hyperactivity Disorder (ADHD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}], 'ancestors': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': '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'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'There is two group of children:\n\n1. Group 1: Children with ADHD\n2. Group 2: Children without ADHD as a control group\n\nBoth group will running the ADHD-VR diagnostic test and goes to diagnosis by child psychiatrist. The outcomes that were analyzed:\n\n1. The sensitivity, specificity and Likelihood ratio of the ADHD-VR diagnostic test in detecting the ADHD clinical symptoms and executive function\n2. Content validity of the ADHD-VR diagnostic test'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2019-05-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2021-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-04-06', 'studyFirstSubmitDate': '2020-04-03', 'studyFirstSubmitQcDate': '2020-04-06', 'lastUpdatePostDateStruct': {'date': '2020-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The sensitivity and specificity of ADHD-VR diagnostic tool towards ADHD clinical symptoms', 'timeFrame': 'up to 30 minutes', 'description': 'The comparing between the ADHD-VR diagnostic test results and expert judgement on ADHD diagnosis'}, {'measure': 'The sensitivity and specificity of ADHD-VR diagnostic tool towards executive function', 'timeFrame': 'up to 30 minues', 'description': 'Comparing between the ADHD-VR diagnostic test results and Behavior Rating Inventory for Executive Function Rating Scale.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ADHD', 'virtual reality,', 'diagnostic tool', 'neuropsychological test', 'Indonesia'], 'conditions': ['ADHD', 'Executive Dysfunction']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria for ADHD group:\n\n* Children with ADHD drug naive\n* Parent willing to participate in the study by signing informed consent\n* Children willing to participate the ADHD-VR diagnostic tool for at least 30 minutes\n\nExclusion Criteria:\n\n* Having untreated chronic physical illnesses\n* Having other mental disorders except ADHD\n\nInclusion Criteria for healthy children group:\n\n* Do not have any mental disorder\n* Do not have untreated chronic physical illnesses\n* Parent willing to participate in the study by signing informed consent\n* Children willing to participate the ADHD-VR diagnostic tool for at least 30 minutes'}, 'identificationModule': {'nctId': 'NCT04337905', 'acronym': 'New', 'briefTitle': 'Virtual Reality (VR) Diagnostic Tool for Attention Deficits/Hyperactivity Disorder (ADHD)', 'organization': {'class': 'OTHER', 'fullName': 'Dr Cipto Mangunkusumo General Hospital'}, 'officialTitle': 'A New Development Diagnostic Tool for ADHD: A VR Approach', 'orgStudyIdInfo': {'id': 'ADHD-VR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Children with ADHD', 'description': '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', 'interventionNames': ['Device: ADHD-VR diagnosis tool']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Children without ADHD', 'description': 'Healthy children that also running the ADHD-VR diagnostic test and also psyhchiatric examination to rule out the ADHD diagnosis and other mental disorders', 'interventionNames': ['Device: ADHD-VR diagnosis tool']}], 'interventions': [{'name': 'ADHD-VR diagnosis tool', 'type': 'DEVICE', 'description': '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".', 'armGroupLabels': ['Children with ADHD', 'Children without ADHD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10430', 'city': 'Jakarta Pusat', 'state': 'DKI Jakarta', 'country': 'Indonesia', 'facility': 'dr. Cipto Mangunkusumo General Hospital', 'geoPoint': {'lat': -6.1818, 'lon': 106.8223}}], 'overallOfficials': [{'name': 'Tjhin Wiguna, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dr Cipto Mangunkusumo General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No decided yet'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tjhin Wiguna', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fakultas Kedokteran Universitas Indonesia', 'class': 'OTHER'}, {'name': 'Dr Cipto Mangunkusumo General Hospital', 'class': 'OTHER'}, {'name': 'Binus University International', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. dr.', 'investigatorFullName': 'Tjhin Wiguna', 'investigatorAffiliation': 'Dr Cipto Mangunkusumo General Hospital'}}}}