Skip to main content
OpenTrials
Completed

NCT Number: NCT02127931

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Attention Deficit Hyperactivity Disorder Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Macalester College

Saint Paul, Minnesota, 55105, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Under the age of 18

Treatment and study plan

Groundskeeper for ADHD group

Device

Groundskeeper, a Video Game Diagnostic Tool for ADHD is administered to probands with ADHD and age, gender matched controls without ADHD.

Groundskeeper for control group

Device

Groundskeeper, a Video Game Diagnostic Tool for ADHD is administered to probands with ADHD and age, gender matched controls without ADHD.

Primary outcomes

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

    Time frame: 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

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

    Time frame: 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.

  3. Correlation of Groundskeeper Incorrect With CPT Commission Errors

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

CogCubed, Corp

Industry

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
May 1, 2014
Registry last updated
Jan 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.