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

NCT02127931 | Completed Results

• 1 other identifier: NCT01711372B
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

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.

Device: Groundskeeper for ADHD group

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.

Device: Groundskeeper for control group

Interventions

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.

ADHD group played Game

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.

Control group played game

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Under the age of 18

Sponsors & Collaborators

• CogCubed, Corp: lead

Study Sites (1)

Macalester College

Saint Paul, Minnesota, 55105, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Results Point of Contact

• Title: Monika Roots, MD
• Organization: CogCubed

monika.d.heller@gmail.com

6122509737

Study Officials

• Monika Roots, MD

  CogCubed, Corp

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

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

Study Record Dates

• First Submitted: April 28, 2014
• First Posted: May 1, 2014
• Study Start: March 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 14, 2020
• Results First Posted: January 14, 2020

Record last verified: 2020-01

Locations

US (1)