N/A
N=18
Predictive Executive Functioning Models Using Interactive Tangible-Graphical Interface Devices in Adults
Attention Deficit Hyperactivity Disorder
Bottom Line
View on ClinicalTrials.gov: NCT02127931 ↗Enrolled (actual)
18
Serious AEs
—
Results posted
Jan 2020
Primary outcome: Primary: Number of Participants That Tested High (6 or More Symptoms) for ADHD by Type Determined by Adult ADHD DSM IV-TR Checklist — 2; 5; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Groundskeeper for ADHD group (Device); Groundskeeper for control group (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- CogCubed, Corp
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants That Tested High (6 or More Symptoms) for ADHD by Type Determined by Adult ADHD DSM IV-TR Checklist |
2; 5; 2 | — |
| PRIMARY Correlation of CPT Commission Errors With ADHD-I and ADHD-C |
0.648; 0.587 | 0.005 sig |
| PRIMARY Correlation of Groundskeeper Incorrect With CPT Commission Errors |
0.587 | 0.013 sig |
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.
Eligibility Criteria
Inclusion Criteria
- Age 18+, males and females
- Individuals with ADHD
- Individuals without ADHD
- Depressive Disorders
- Anxiety Disorders
- High functioning Autism Spectrum Disorders
- Mood Disorders
Exclusion Criteria
- Under the age of 18
Data sourced from ClinicalTrials.gov (NCT02127931). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.