Attention Deficit Hyperactivity DisorderNCT02127931
Predictive Executive Functioning Models Using Interactive Tangible-Graphical Interface Devices in Adults
A study testing Groundskeeper for ADHD group in people with Attention Deficit Hyperactivity Disorder, run by CogCubed, Corp at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Groundskeeper for ADHD group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to 1 Dec 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18+, males and females
- Individuals with ADHD
- Individuals without ADHD
- Depressive Disorders
- Anxiety Disorders
- High functioning Autism Spectrum Disorders
- Mood Disorders
Who cannot join
- Under the age of 18
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the detailed description
This trial builds on the previous results of our phase 1 trials in children ages 6-17 used to create the predictive algorithms to analyze the data and predict the likelihood of ADHD diagnosis based on patterns of game play behavior. Participants in this study will complete the Schedule for Affective Disorders and Schizophrenia (SADS), the DSM IV Adult ADHD Checklist, Hamilton Rating Scal for Depression (HRSD), the Hamilton Rating Scale for Anxiety (HAM-A), and complete the Conner's Continuous Performance test (CPT 3).
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Groundskeeper for ADHD group, Groundskeeper for control group
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Groundskeeper for ADHD groupDevice
Groundskeeper, a Video Game Diagnostic Tool for ADHD is administered to probands with ADHD and age, gender matched controls without ADHD.
Groundskeeper for control groupDevice
Groundskeeper, a Video Game Diagnostic Tool for ADHD is administered to probands with ADHD and age, gender matched controls without ADHD.
| Study group | Role | What they receive |
|---|---|---|
| ADHD group played Game | Experimental | Groundskeeper, a Video Game Diagnostic Tool for ADHD is administer to probands with ADHD and age, gender matched controls without ADHD. The game was played on Sifteo cubes. Receives: Device: Groundskeeper for ADHD group |
| Control group played game | Active comparator | Groundskeeper, a Video Game Diagnostic Tool for ADHD is administer to probands with ADHD and age, gender matched controls without ADHD. The game was played on Sifteo cubes. Receives: Device: Groundskeeper for control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants That Tested High (6 or More Symptoms) for ADHD by Type Determined by Adult ADHD DSM IV-TR Checklist
Adult ADHD DSM IV-TR Checklist for determining ADHD subtypes: inattentive ADHD (ADHD-I), Hyperactive/impulsive ADHD (ADHD-H/I) and Combined ADHD (ADHD-C). Company no longer exitsts, and no longer has access to data collected. Only information from draft publication available
Measured: 10 minutes
Correlation of CPT Commission Errors With ADHD-I and ADHD-C
Continuous performance task (CPT), participants are asked to press the space bar when they are presented with any letter except the letter "X". The participant must refrain from clicking if they see the letter "X" presented.
Measured: 14 minutes
Correlation of Groundskeeper Incorrect With CPT Commission Errors
Groundskeeper is a game, there are four cubes and a base device, three of the cubes display a background of a grassy field, with occasional stimuli that pop up. The fourth cube displays a mallet. When a gopher is displayed on one of the cubes, the user must hit the gopher with the mallet. Groundskeeper incorrect counts of the number of incorrect responses when a target stimulus is presented. Continuous performance task (CPT), participants are asked to press the spacebar each time a letter appears in the middle of the screen, except when the letter is "X." If the letter is an "X", the participant should do nothing. Commission errors were when participant pressed the spacebar when an "X" appeared. Company no longer exists, and no longer has access to data collected. Only information from draft publication available.
Measured: 45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2014 (estimated)
- Study startMar 2014
- Primary completion1 Dec 2016
- Study completion1 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Video Game Diagnostic Tool Groundskeeper, a Video Game Diagnostic Tool for ADHD is administer to probands with ADHD and age, gender matched controls without ADHD.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- CogCubed, Corp
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Monika Roots, CogCubed, Corp
- Investigators
- Monika Roots, MD, Principal investigator, CogCubed, Corp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02127931
- Sponsor's protocol ID
- NCT01711372B
- Status last verified
- Jan 2020
- First submitted
- 28 Apr 2014
- Last updated
- 14 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Executive Functioning Models Using Interactive Tangible-Graphical Interface Devices in Adults
- ClinicalTrials.gov ID
- NCT02127931
- Acronym / sponsor ID
- NCT01711372B
- Conditions
- Attention Deficit Hyperactivity Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- CogCubed, CorpIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- 1 Dec 2016 (actual)
- Study completion
- 1 Dec 2016 (actual)
- First posted
- 1 May 2014 (estimated)
- Results
- Posted 14 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This trial builds on the previous results of our phase 1 trials in children ages 6-17 used to create the predictive algorithms to analyze the data and predict the likelihood of ADHD diagnosis based on patterns of game play behavior. Participants in this study will complete the Schedule for Affective Disorders and Schizophrenia (SADS), the DSM IV Adult ADHD Checklist, Hamilton Rating Scal for Depression (HRSD), the Hamilton Rating Scale for Anxiety (HAM-A), and complete the Conner's Continuous Performance test (CPT 3).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Video Game Diagnostic Tool Groundskeeper, a Video Game Diagnostic Tool for ADHD is administer to probands with ADHD and age, gender matched controls without ADHD.
| Arm | Type | Receives |
|---|---|---|
| ADHD group played Game | Experimental | Device: Groundskeeper for ADHD groupGroundskeeper, a Video Game Diagnostic Tool for ADHD is administer to probands with ADHD and age, gender matched controls without ADHD. The game was played on Sifteo cubes. |
| Control group played game | Active comparator | Device: Groundskeeper for control groupGroundskeeper, a Video Game Diagnostic Tool for ADHD is administer to probands with ADHD and age, gender matched controls without ADHD. The game was played on Sifteo cubes. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18+, males and females
- Individuals with ADHD
- Individuals without ADHD
- Depressive Disorders
- Anxiety Disorders
Key exclusion criteria (1 listed)
- Under the age of 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Groundskeeper for ADHD groupGroundskeeper, a Video Game Diagnostic Tool for ADHD is administered to probands with ADHD and age, gender matched controls without ADHD. | Device | ADHD group played Game |
| Groundskeeper for control groupGroundskeeper, a Video Game Diagnostic Tool for ADHD is administered to probands with ADHD and age, gender matched controls without ADHD. | Device | Control group played game |
Primary outcome
Number of Participants That Tested High (6 or More Symptoms) for ADHD by Type Determined by Adult ADHD DSM IV-TR Checklist
Time frame: 10 minutes
Adult ADHD DSM IV-TR Checklist for determining ADHD subtypes: inattentive ADHD (ADHD-I), Hyperactive/impulsive ADHD (ADHD-H/I) and Combined ADHD (ADHD-C). Company no longer exitsts, and no longer has access to data collected. Only information from draft publication available
Correlation of CPT Commission Errors With ADHD-I and ADHD-C
Time frame: 14 minutes
Continuous performance task (CPT), participants are asked to press the space bar when they are presented with any letter except the letter "X". The participant must refrain from clicking if they see the letter "X" presented.
Correlation of Groundskeeper Incorrect With CPT Commission Errors
Time frame: 45 minutes
Groundskeeper is a game, there are four cubes and a base device, three of the cubes display a background of a grassy field, with occasional stimuli that pop up. The fourth cube displays a mallet. When a gopher is displayed on one of the cubes, the user must hit the gopher with the mallet. Groundskeeper incorrect counts of the number of incorrect responses when a target stimulus is presented. Continuous performance task (CPT), participants are asked to press the spacebar each time a letter appears in the middle of the screen, except when the letter is "X." If the letter is an "X", the participant should do nothing. Commission errors were when participant pressed the spacebar when an "X" appeared. Company no longer exists, and no longer has access to data collected. Only information from draft publication available.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Monika Roots, MD principal investigator
CogCubed, Corp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Groundskeeper for ADHD group in people with Attention Deficit Hyperactivity Disorder, run by CogCubed, Corp at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants That Tested High (6 or More Symptoms) for ADHD by Type Determined by Adult ADHD DSM IV-TR Checklist (time frame: 10 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2020.