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临床试验/NCT04337905
NCT04337905Unknown不适用

A New Development Diagnostic Tool for ADHD: A VR Approach

Tjhin Wiguna2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年5月25日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
2
主要终点
The sensitivity and specificity of ADHD-VR diagnostic tool towards ADHD clinical symptoms

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Triple (Care Provider, Investigator, Outcomes Assessor)

盲法说明

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

入排标准

年龄范围
6 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

The sensitivity and specificity of ADHD-VR diagnostic tool towards ADHD clinical symptoms

时间窗: 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

时间窗: up to 30 minues

Comparing between the ADHD-VR diagnostic test results and Behavior Rating Inventory for Executive Function Rating Scale.

次要结局

未报告次要终点

研究者

发起方
Tjhin Wiguna
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Tjhin Wiguna

Prof. Dr. dr.

Dr Cipto Mangunkusumo General Hospital

研究点 (2)

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