Clinical trial NCT01711372: Predictive Executive Functioning Models Using Interactive Tangible-Graphical Interface Devices
Official title: Predictive Executive Functioning Models Using Interactive Tangible-Graphical Interface Devices, Phase 2 Trials
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: ADHD
Lead sponsor: CogCubed, Corp
Sponsor class: INDUSTRY
First posted: 2012-10-22
Enrollment: 113
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients were those with ADHD and age and gender matched controls who completed a game placed on Sifteo cubes to assess for ADHD. The intervention was a game to screen for ADHD.
Primary purpose: SCREENING

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Area Under the Receiver Operating Characteristic (ROC) Curve- Groundskeeper Game
timeFrame: 30 minutes
Secondary outcomes:
measure: Area Under the Receiver Operating Characteristic (ROC) Curve- Conners Brief Rating Scale Parent Version (Inattention Subscale)
timeFrame: 30 minutes
measure: Area Under the Receiver Operating Characteristic (ROC) Curve- Continuous Performance Task (CPT)
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Saint Louis Park
country: United States
facility: Groves Academy
state: Minnesota
city: Waconia
country: United States
facility: Egli Assessment
state: Minnesota
Study officials:
affiliation: CogCubed, Corp
name: Monika D Roots, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CogCubed, Corp
name: Jaideep Srivastava, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Faraone SV, Newcorn JH, Antshel KM, Adler L, Roots K, Heller M. The Groundskeeper Gaming Platform as a Diagnostic Tool for Attention-Deficit/Hyperactivity Disorder: Sensitivity, Specificity, and Relation to Other Measures. J Child Adolesc Psychopharmacol. 2016 Oct;26(8):672-685. doi: 10.1089/cap.2015.0174. Epub 2016 Apr 22.