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.

Study Overview

• Status: Completed
• Conditions: Attention Deficit Hyperactivity Disorder
• Intervention / Treatment: Device: Groundskeeper for ADHD group; Device: Groundskeeper for control group

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Saint Paul, Minnesota, United States, 55105
      • Macalester College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ADHD group played Game; 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.	Device: Groundskeeper for ADHD group; Groundskeeper, a Video Game Diagnostic Tool for ADHD is administered to probands with ADHD and age, gender matched controls without ADHD.
Active Comparator: Control group played game; 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.	Device: Groundskeeper for control group; Groundskeeper, a Video Game Diagnostic Tool for ADHD is administered to probands with ADHD and age, gender matched controls without ADHD.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants That Tested High (6 or More Symptoms) for ADHD by Type Determined by Adult ADHD DSM IV-TR Checklist	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	10 minutes
Correlation of CPT Commission Errors With ADHD-I and ADHD-C	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.	14 minutes
Correlation of Groundskeeper Incorrect With CPT Commission Errors	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.	45 minutes

Collaborators and Investigators

• Sponsor: CogCubed, Corp
• Investigators: Principal Investigator: Monika Roots, MD, CogCubed, Corp

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: April 28, 2014
• First Submitted That Met QC Criteria: April 30, 2014
• First Posted (Estimate): May 1, 2014

Study Record Updates

• Last Update Posted (Actual): January 14, 2020
• Last Update Submitted That Met QC Criteria: January 5, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity
• Other Study ID Numbers: NCT01711372B