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This study aims to demonstrate the accuracy of the MT1 algorithm using the MindTension biometric sensor device as a diagnostic aid for healthcare providers in diagnosing ADHD in youth ages ≥ 6 to ≤17 years.
The study aims to demonstrate the accuracy of the MT1 algorithm. The output of the MT1 algorithm will be compared to a Gold Standard clinical diagnosis made by specialist clinician diagnosis supported by the Kiddie SADS Present and Lifetime semi-structured interview (K-SADS-PL) and norm-referenced measures of current ADHD symptom frequency and severity using the ADHD-RS-5 rating scale. Diagnosis will be scaled according to the Diagnostic and Statistical Manual of Mental Disorders- 5 (DSM-5) criteria, and made with agreement between two licensed specialists in ADHD (a Clinical Psychologist and a Psychiatrist).
Further to the above, demonstrate that the agreement between the MT1 output and the specialist clinician diagnosis will be non-inferior to the level of agreement between the clinician diagnosis with the Test of Visual Attention (TOVA) FDA cleared device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADHD group | Experimental | Subjects will be evaluated for ADHD using clinically established reference standard interviews and psychometric tools with demonstrated validity, including the K-SADS and ADHD-RS-5, in accordance with DSM-5 criteria. IQ will be estimated using two subtests of the WASI. |
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| Non-ADHD group | Experimental | Subjects will be evaluated using clinically established reference standard interviews and psychometric tools with demonstrated validity, including the K-SADS and ADHD-RS-5, in accordance with DSM-5 criteria. IQ will be estimated using two subtests of the WASI. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MT1 Auditory startle response patterns analysis algorithm | Device | Objective measurements of attention and inhibition. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Agreement Rate (OAR) - probability that the test will be normal and the condition is normal or positive and the condition is positive, out of all subjects. | The outcome measure will be calculated by using the following formula: Over All Agreement = (True Positive + True Negative) / (True Positive + True Negative + False Positive + False Negative) X 100. | From the beginning of clinical assessment until the end of testing (approximately 1-2 days). |
| Measure | Description | Time Frame |
|---|---|---|
| Positive Predicted Value (PPV) - conditional probability that the condition will be positive if the test is positive. | The outcome measure will be calculated using the following formula: Positive Predicted Value = (True Positive) / (True Positive + False Positive) X 100 | From the beginning of clinical assessment until the end of testing (approximately 1-2 days). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jeffrey Newcorn, MD Professor | Contact | 212-659-8705 | jeffrey.newcorn@mssm.edu | |
| Beth Krone, PhD, MS | Contact | 212 241 8012 | beth.krone@mssm.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Newcorn, MD Professor | Director, Division of ADHD and Learning Disorders Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | Recruiting | New York | New York | 10029 | United States |
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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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The study will include a group of subjects who have ADHD and subjects who are healthy controls based on the specialist clinician assessment.
Following the specialist clinician assessment each subject will undergo a test using the FDA cleared T.O.V.A and MindTension's MT1.
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| T.O.V.A. Continuous Performance Test | Device | Objective measurements of attention and inhibitory control. |
|
| Negative Predicted Value (NPV) - conditional probability that the condition will be normal if the test is normal. | The outcome measure will be calculated using the following formula: Negative Predicted Value = (True Negative) / (True Negative + False Negative) X 100 | From the beginning of clinical assessment until the end of testing (approximately 1-2 days). |
| Sensitivity - conditional probability that the test will be positive if the condition is positive. | The outcome measure will be calculated using the following formula: Sensitivity = (True Positive) / (True Positive + False Negative) X 100 | From the beginning of clinical assessment until the end of testing (approximately 1-2 days). |
| Specificity - conditional probability that the test will be normal if the condition is normal. | The outcome measure will be calculated using the following formula: Specificity = (True Negative) / (True Negative + False Positive) X 100 | From the beginning of clinical assessment until the end of testing (approximately 1-2 days). |