跳至主要内容
临床试验/NCT02127931
NCT02127931已完成不适用

Predictive Executive Functioning Models Using Interactive Tangible-Graphical Interface Devices in Adults

CogCubed, Corp1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2014年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
18
试验地点
1
主要终点
Correlation of CPT Commission Errors With ADHD-I and ADHD-C

研究概览

简要总结

Current diagnostic aids used in treating ADHD are currently expensive, time intensive, and provide little information about accessory movements in response to a stimulus.

Tests such as the Conners' Rating Scale require subjective responses from parents and teachers, making coordination difficult. The computerized Conners' Continuous Performance Test (CPT) provides objective data in regards to inattention and impulsive patterns of response. However, it does not provide data regarding accessory movements such as restlessness, hyperactivity, and other inappropriate movements. If the subject taking the exam has a reading disorder, it will impair his or her ability to respond accurately and it will increase response time. The T.O.V.A. is another computer based test used as a diagnostic aid for ADHD, which uses a microswitch to record responses. It does utilize auditory and visual stimuli, which removes the reading level limitation. However, it is unable to measure to measure accessory movements that may be contributing to reaction time and errors of omission and commission.

Because of these limitations, a new company called CogCubed has created a new game based on the Sifteo Cube (http://www.sifteo.com) platform. These new hands-on digitized cubes are unique, motion-sensitive wireless blocks that contain multiple sensors that can interact with one another. CogCubed is providing the data for this study. The game will be played in a 30 minute sessions by subjects aged 18 and over. Subjects recruited to play the game will be those with ADHD and those without, matched by gender. Those with comorbidities of developmental delay, mental retardation, psychosis, schizophrenia, bipolar disorder and substance use disorders will be excluded, as well as any physiological disability that affects upper limb movement and/or coordination. Informed consent will be obtained from participant prior to administering the game.

The hypothesis is that by analyzing data generated from this new gaming platform named Sifteo for which a game was created, which uses auditory and visual stimuli and distracters, the investigators expect that they will be able to provide a more accurate profile of impulsivity and inattention. The investigators expect that inattention will have more errors of omission and less tilt movements than control and impulsivity will be represented as more commission and greater tilting movements than control.

详细描述

This trial builds on the previous results of our phase 1 trials in children ages 6-17 used to create the predictive algorithms to analyze the data and predict the likelihood of ADHD diagnosis based on patterns of game play behavior. Participants in this study will complete the Schedule for Affective Disorders and Schizophrenia (SADS), the DSM IV Adult ADHD Checklist, Hamilton Rating Scal for Depression (HRSD), the Hamilton Rating Scale for Anxiety (HAM-A), and complete the Conner's Continuous Performance test (CPT 3).

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
Double (Participant, Investigator)

盲法说明

The participant does not know if they have ADHD symptoms or not and the investigator who is administering the game does not know what group the patient is in.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Age 18+, males and females
  • •Individuals with ADHD
  • •Individuals without ADHD
  • •Depressive Disorders
  • •Anxiety Disorders
  • •High functioning Autism Spectrum Disorders
  • •Mood Disorders

排除标准

  • •Under the age of 18

研究组 & 干预措施

ADHD group played Game

Experimental

Groundskeeper, a Video Game Diagnostic Tool for ADHD is administer to probands with ADHD and age, gender matched controls without ADHD. The game was played on Sifteo cubes.

干预措施: Groundskeeper for ADHD group (Device)

Control group played game

Active Comparator

Groundskeeper, a Video Game Diagnostic Tool for ADHD is administer to probands with ADHD and age, gender matched controls without ADHD. The game was played on Sifteo cubes.

干预措施: Groundskeeper for control group (Device)

结局指标

主要结局

Correlation of CPT Commission Errors With ADHD-I and ADHD-C

时间窗: 14 minutes

Continuous performance task (CPT), participants are asked to press the space bar when they are presented with any letter except the letter "X". The participant must refrain from clicking if they see the letter "X" presented.

Correlation of Groundskeeper Incorrect With CPT Commission Errors

时间窗: 45 minutes

Groundskeeper is a game, there are four cubes and a base device, three of the cubes display a background of a grassy field, with occasional stimuli that pop up. The fourth cube displays a mallet. When a gopher is displayed on one of the cubes, the user must hit the gopher with the mallet. Groundskeeper incorrect counts of the number of incorrect responses when a target stimulus is presented. Continuous performance task (CPT), participants are asked to press the spacebar each time a letter appears in the middle of the screen, except when the letter is "X." If the letter is an "X", the participant should do nothing. Commission errors were when participant pressed the spacebar when an "X" appeared. Company no longer exists, and no longer has access to data collected. Only information from draft publication available.

Number of Participants That Tested High (6 or More Symptoms) for ADHD by Type Determined by Adult ADHD DSM IV-TR Checklist

时间窗: 10 minutes

Adult ADHD DSM IV-TR Checklist for determining ADHD subtypes: inattentive ADHD (ADHD-I), Hyperactive/impulsive ADHD (ADHD-H/I) and Combined ADHD (ADHD-C). Company no longer exitsts, and no longer has access to data collected. Only information from draft publication available

次要结局

未报告次要终点

研究者

发起方
CogCubed, Corp
申办方类型
Industry
责任方
Principal Investigator
主要研究者

Monika Roots

MD

CogCubed, Corp

研究点 (1)

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