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Predictive Executive Functioning Models Using Interactive Tangible-Graphical Interface Devices

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ClinicalTrials.gov Identifier: NCT01711372
Recruitment Status : Unknown
Verified March 2015 by CogCubed, Corp.
Recruitment status was:  Recruiting
First Posted : October 22, 2012
Last Update Posted : March 13, 2015
Sponsor:
Information provided by (Responsible Party):
CogCubed, Corp

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. One in ten children, ages 5 to 17, has been diagnosed with ADHD.

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 ages 6-17. Subjects recruited to play the game will be those with ADHD and those without, matched by gender and age. 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 parents and patient prior to administering the game. Parents will fill out a Conner's Brief Rating Scale and a Conner's Brief Rating Scale, Teacher's version will also be supplied to be filled out at school.

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. This trial builds on the previous results of our phase 1 trials used to create the predictive algorithms to analyze the data and predict the likelihood of ADHD diagnosis based on patterns of game play behavior.


Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Device: Groundskeeper Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Predictive Executive Functioning Models Using Interactive Tangible-Graphical Interface Devices, Phase 2 Trials
Study Start Date : June 2012
Estimated Primary Completion Date : December 2015

Arm Intervention/treatment
Experimental: Video Game Diagnostic Tool
Video Game Diagnostic Tool for ADHD is administer to probands with ADHD and age, gender matched controls without ADHD.
Device: Groundskeeper
A game created to be played on Sifteo Cubes to be used as a diagnostic aid for ADHD.




Primary Outcome Measures :
  1. Omissions [ Time Frame: Assessed at first visit when enter study, day 1 ]
    Omissions (no response by subject of hitting correct stimulus with another cube)


Secondary Outcome Measures :
  1. Commission [ Time Frame: Assessed at first visit when enter study, day 1 ]
    Commissions (stimulus, wrong response exhibited by subject hitting an incorrect stimulus when the correct stimulus is being presented on another game cube)


Other Outcome Measures:
  1. Hit Reaction Time Standard Deviation [ Time Frame: Assessed at first visit when enter study, day 1 ]
    Hit Reaction Time Standard Deviation (measure of response speed consistency, calculated as standard deviation of reaction time that is measured in 1/5th's of a second)

  2. Accuracy [ Time Frame: Assessed at first visit when enter study, day 1 ]
    Accuracy (number of correct responses to the pre-identified correct stimulus)

  3. Detectability [ Time Frame: Assessed at first visit when enter study, day 1 ]
    •Detectability (difference between signal and noise disturbances measured as reaction time in 1/5th's of seconds)

  4. Perseverations [ Time Frame: Assessed at first visit when enter study, day 1 ]
    Perseverations (any reaction time less than 100ms is a perseverative response: a slow response to a preceding stimuli, random response, or response repeated without consideration for stimuli)

  5. Response Style [ Time Frame: Assessed at first visit when enter study, day 1 ]
    Response Style: pattern of response such as is the pattern or response hesitant in general (lack of commissions). High on this indicates person avoids commissions. (Degree of tilt and pauses in tilt pattern to hit a cube measured as change in movement in cube in x, y and z axis measured in degree of change from zero).

  6. Attention [ Time Frame: Assessed at first visit when enter study, day 1 ]
    Attention: # of responses to target stimulus (good responses) (ability to detect, evaluate and respond correctly).

  7. Hyperactivity [ Time Frame: Assessed at first visit when enter study, day 1 ]
    Hyperactivity: tilt and length of time in tilt for any stimulus (correct or not). Tilt is measured as degree of change in x, y and z axis from zero.

  8. Impulsivity [ Time Frame: Assessed at first visit when enter study, day 1 ]
    Impulsivity: # responses to non-target stimulus (groundskeeper and grass) (responding without evaluating the stimulus).

  9. Reaction Time [ Time Frame: Assessed at first visit when enter study, day 1 ]
    Reaction time: Length of time has reaction to any stimulus measured in 1/5th's of a second.

  10. Incorrect Reaction Time [ Time Frame: Assessed at first visit when enter study, day 1 ]
    Hit Reaction Time (average speed of incorrect response to identified stimulus, measured in 1/5th's of seconds)

  11. Excess movements [ Time Frame: Assessed at first visit when enter study, day 1 ]
    Excess movements (flips of cubes measured in tilt, clicks of the cube face): measure of hyperactivity- severity and length of time doing excess movements



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 6-17, males and females
  • Individuals with ADHD
  • Individuals without ADHD
  • Depressive Disorders
  • Anxiety Disorders
  • High functioning Autism Spectrum Disorders
  • Mood Disorders

Exclusion Criteria:

  • Developmental Delay
  • IQ below 70
  • Oppositional Defiant Disorders
  • Conduct Disorders
  • Low functioning Autism Spectrum Disorders
  • Psychosis
  • Substance Use Disorders
  • Medical comorbidities that involve any motoric disability that affects upper-limb movement and/or strength

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01711372


Contacts
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Contact: Monika Roots, MD 612-250-9737 helle192@umn.edu

Locations
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United States, Minnesota
Groves Academy Completed
St Louis Park, Minnesota, United States, 55416
Egli Assessment Active, not recruiting
Waconia, Minnesota, United States, 55387
United States, Ohio
Senders Pediatrics Recruiting
Cleveland, Ohio, United States, 44121
Contact: Kimberly Blozie    216-291-9424      
Principal Investigator: Shelly Senders, MD         
Sponsors and Collaborators
CogCubed, Corp
Investigators
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Principal Investigator: Monika D Roots, MD CogCubed, Corp
Principal Investigator: Jaideep Srivastava, PhD CogCubed, Corp

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Responsible Party: CogCubed, Corp
ClinicalTrials.gov Identifier: NCT01711372     History of Changes
Other Study ID Numbers: 131209-12
First Posted: October 22, 2012    Key Record Dates
Last Update Posted: March 13, 2015
Last Verified: March 2015

Keywords provided by CogCubed, Corp:
ADHD

Additional relevant MeSH terms:
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Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders