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Predictive Executive Functioning Models Using Interactive Tangible-Graphical Interface Devices

C

CogCubed

Status

Completed

Conditions

Attention Deficit Hyperactivity Disorder

Treatments

Device: Groundskeeper game for controls
Device: Groundskeeper game for ADHD

Study type

Interventional

Funder types

Industry

Identifiers

NCT01711372
131209-12

Details and patient eligibility

About

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.

Full description

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.

Enrollment

113 patients

Sex

All

Ages

6 to 17 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Age 6-17, males and females
  • Individuals with ADHD
  • Individuals without ADHD
  • Depressive Disorders
  • Anxiety Disorders
  • Oppositional Defiant Disorder
  • Panic Disorder
  • Eating Disorder

Exclusion criteria

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

Trial design

Primary purpose

Screening

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

113 participants in 2 patient groups, including a placebo group

Controls who played Groundskeeper game
Placebo Comparator group
Description:
Controls played a go/no go task on Sifteo cubes to asses for attentional capabilities.
Treatment:
Device: Groundskeeper game for controls
Probands played groundskeeper game
Active Comparator group
Description:
Patients with ADHD played a go/no go task on Sifteo cubes to asses for attentional capabilities
Treatment:
Device: Groundskeeper game for ADHD

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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