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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Controls who played Groundskeeper game | Placebo Comparator | Controls played a go/no go task on Sifteo cubes to asses for attentional capabilities. |
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| Probands played groundskeeper game | Active Comparator | Patients with ADHD played a go/no go task on Sifteo cubes to asses for attentional capabilities |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Groundskeeper game for controls | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Receiver Operating Characteristic (ROC) Curve- Groundskeeper Game | ROC charts the false-positive (horizontal axis) and the sensitivity or true-positive rate (vertical axis) of the Groundskeeper game at discriminating child psychiatric patients with and without ADHD. Determines diagnostic accuracy of Groundskeeper game for ADHD. For each participant, predicted values were computed from the logistic regression models (correcting for age, sex and medication status). For each successive point on the logit scale sensitivity and specificity of the logit was computed as a predictor of ADHD diagnosis, by predicting those higher than the cut-point to have ADHD and the others not to have ADHD. These data were used to draw the ROC curve. ROC analysis summarized diagnostic efficiency with the area under the curve (AUC) statistic. The AUC ranges from 0.5 (for a diagnostically useless test) to 1.0 (for a diagnostic test that is a perfect predictor). | 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Receiver Operating Characteristic (ROC) Curve- Conners Brief Rating Scale Parent Version (Inattention Subscale) | Parent completed the Connors Brief rating Scale Parent Version, with the Inattention subscale extracted for analysis. Scores for this assessment are converted to percentile scores for each age group with higher scores indicating more likelihood of ADHD. ROC charts the false-positive rate (horizontal axis) and the sensitivity or true-positive rate (vertical axis) of discriminating child psychiatric patients with and without ADHD. Determines diagnostic accuracy of Conners Scale for ADHD. ROC analysis summarizes diagnostic efficiency with the area under the curve (AUC) statistic. The AUC ranges from 0.5 (for a diagnostically useless test) to 1.0 (for a diagnostic test that is a perfect predictor). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Monika D Roots, MD | CogCubed, Corp | Principal Investigator |
| Jaideep Srivastava, PhD | CogCubed, Corp | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Groves Academy | Saint Louis Park | Minnesota | 55416 | United States | ||
| Egli Assessment |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27105181 | Result | 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. |
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113 patients were screened for ADHD vs no ADHD. Those with ADHD were asked to not take stimulant medications for at least 3 days prior to participating. Company no longer exists and no longer has access to data collected. Only information in published study results available.
Invited for participation consecutive patients referred to a child psychiatrist. From this cohort of patients, two groups formed. Patients who had received ADHD diagnosed and those who had not.
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| ID | Title | Description |
|---|---|---|
| FG000 | ADHD Group | Patients with ADHD played a go/no go task on Sifteo cubes to assess for attentional capabilities. Groundskeeper Game: The Groundskeeper game is a go/no-go task that captures reaction time and movement using the accelerometers and touch capabilities on the Sanvello cubes. |
| FG001 | Control Group | Controls played a go/no go task on Sifteo cubes to assess for attentional capabilities. Groundskeeper Game: The Groundskeeper game is a go/no-go task that captures reaction time and movement using the accelerometers and touch capabilities on the Sanvello cubes. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The patients who completed all screening tests and intervention for this trial were 113 patients. Company no longer exists. Only information in published study results available.
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| ID | Title | Description |
|---|---|---|
| BG000 | ADHD Group | Patients with ADHD played a go/no go task on Sifteo cubes to asses for attentional capabilities. Groundskeeper Game: 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Area Under the Receiver Operating Characteristic (ROC) Curve- Groundskeeper Game | ROC charts the false-positive (horizontal axis) and the sensitivity or true-positive rate (vertical axis) of the Groundskeeper game at discriminating child psychiatric patients with and without ADHD. Determines diagnostic accuracy of Groundskeeper game for ADHD. For each participant, predicted values were computed from the logistic regression models (correcting for age, sex and medication status). For each successive point on the logit scale sensitivity and specificity of the logit was computed as a predictor of ADHD diagnosis, by predicting those higher than the cut-point to have ADHD and the others not to have ADHD. These data were used to draw the ROC curve. ROC analysis summarized diagnostic efficiency with the area under the curve (AUC) statistic. The AUC ranges from 0.5 (for a diagnostically useless test) to 1.0 (for a diagnostic test that is a perfect predictor). | Data from both participants with and without ADHD used in calculation of AUC of ROC. Diagnostic accuracy applies to both arm/groups of participants. Company no longer exists. Only information in published study results available. | Posted | Number | Proportion of accurate ADHD Diagnoses | 30 minutes |
Company no longer exits. Only information in published study results available. No information available on monitoring/frequency of Adverse Events
Company no longer exits. Only information in published study results available. No information available on monitoring/frequency of Adverse Events
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ADHD Group | Patient with ADHD played a go/no go task on Sifteo cubes to asses for attentional capabilities. Groundskeeper Game: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Monika Roots, Chief Medical Officer | CogCubed | 6173082009 | monika@cogcubed.com |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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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.
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The person having the patient play the came did not know if the patient had ADHD or not.
| Groundskeeper game for ADHD | 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. |
|
| 30 minutes |
| Area Under the Receiver Operating Characteristic (ROC) Curve- Continuous Performance Task (CPT) | CPT measures sustained attention. Participants were asked to press the space bar whenever any letter except the letter "X: appeared on the computer screen. Used the percent certainty that the CPT II results were in the clinical range in this analysis. ROC charts the false-positive rate (horizontal axis) and the sensitivity or true-positive rate (vertical axis) of discriminating child psychiatric patients with and without ADHD. Determines diagnostic accuracy of Conners scales for ADHD. ROC analysis summarizes diagnostic efficiency with the Area Under the Curve (AUC) statistic. The AUC ranges from 0.5 (for a diagnostically useless test) to 1.0 (for a diagnostic test that is a perfect predictor). | 30 minutes |
| Waconia |
| Minnesota |
| 55387 |
| United States |
| Control Group |
Controls played a go/no go task on Sifteo Cubes to asses for attentional capabilities. Groundskeeper Game: 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Psychiatric Disorders | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | All Participants in the Study With and Without ADHD | Data from both participants with and without ADHD used in calculation of AUC of ROC. Diagnostic accuracy applies to both arm/groups of participants. Company no longer exists. Only information in published study results available. |
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| Secondary | Area Under the Receiver Operating Characteristic (ROC) Curve- Conners Brief Rating Scale Parent Version (Inattention Subscale) | Parent completed the Connors Brief rating Scale Parent Version, with the Inattention subscale extracted for analysis. Scores for this assessment are converted to percentile scores for each age group with higher scores indicating more likelihood of ADHD. ROC charts the false-positive rate (horizontal axis) and the sensitivity or true-positive rate (vertical axis) of discriminating child psychiatric patients with and without ADHD. Determines diagnostic accuracy of Conners Scale for ADHD. ROC analysis summarizes diagnostic efficiency with the area under the curve (AUC) statistic. The AUC ranges from 0.5 (for a diagnostically useless test) to 1.0 (for a diagnostic test that is a perfect predictor). | Data from both participants with and without ADHD used in calculation of AUC of ROC. Diagnostic accuracy applies to both arm/groups of participants. Company no longer exists. Only information in published study results available. | Posted | Number | Proportion of accurate ADHD Diagnoses | 30 minutes |
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| Secondary | Area Under the Receiver Operating Characteristic (ROC) Curve- Continuous Performance Task (CPT) | CPT measures sustained attention. Participants were asked to press the space bar whenever any letter except the letter "X: appeared on the computer screen. Used the percent certainty that the CPT II results were in the clinical range in this analysis. ROC charts the false-positive rate (horizontal axis) and the sensitivity or true-positive rate (vertical axis) of discriminating child psychiatric patients with and without ADHD. Determines diagnostic accuracy of Conners scales for ADHD. ROC analysis summarizes diagnostic efficiency with the Area Under the Curve (AUC) statistic. The AUC ranges from 0.5 (for a diagnostically useless test) to 1.0 (for a diagnostic test that is a perfect predictor). | Data from both participants with and without ADHD used in calculation of AUC of ROC. Diagnostic accuracy applies to both arm/groups of participants. Company no longer exists. Only information in published study results available. | Posted | Number | Proportion of accurate ADHD Diagnoses | 30 minutes |
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| EG001 | Control Group | Patient with ADHD played a go/no go task on Sifteo cubes to asses for attentional capabilities. Groundskeeper Game: 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. | 0 | 0 | 0 | 0 | 0 | 0 |
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