Predictive Executive Functioning Models Using Interactive Tangible-Graphical Interface Devices

NCT ID: NCT01711372

Last Updated: 2019-12-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 113 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-01
• Study Completion Date: 2016-12-05

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.

Conditions

Attention Deficit Hyperactivity Disorder

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: DOUBLE

Study Groups

Controls who played Groundskeeper game

Controls played a go/no go task on Sifteo cubes to asses for attentional capabilities.

Group Type: PLACEBO_COMPARATOR

Groundskeeper game for controls

Intervention Type: DEVICE

The Groundskeeper game is a go/no go task that captures reaction time and movement using the accelerometers and touch capabilities of the Sifteo cubes.

Probands played groundskeeper game

Patients with ADHD played a go/no go task on Sifteo cubes to asses for attentional capabilities

Group Type: ACTIVE_COMPARATOR

Groundskeeper game for ADHD

Intervention Type: DEVICE

The Groundskeeper game is a go/no go task that captures reaction time and movement using the accelerometers and touch capabilities of the Sifteo cubes.

Interventions

Groundskeeper game for controls

The Groundskeeper game is a go/no go task that captures reaction time and movement using the accelerometers and touch capabilities of the Sifteo cubes.

Intervention Type: DEVICE

Groundskeeper game for ADHD

The Groundskeeper game is a go/no go task that captures reaction time and movement using the accelerometers and touch capabilities of the Sifteo cubes.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

CogCubed, Corp

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Monika D Roots, MD

Role: PRINCIPAL_INVESTIGATOR

CogCubed, Corp

Jaideep Srivastava, PhD

Role: PRINCIPAL_INVESTIGATOR

CogCubed, Corp

Locations

Groves Academy

Saint Louis Park, Minnesota, United States

Egli Assessment

Waconia, Minnesota, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 27105181 (View on PubMed)

Other Identifiers

131209-12

Identifier Type: -

Identifier Source: org_study_id