ADHD
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEMT1 Auditory startle response patterns analysis algorithm
Objective measurements of attention and inhibition.
DEVICET.O.V.A. Continuous Performance Test
Objective measurements of attention and inhibitory control.
Sponsors
MindTension
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
1. Parent provision of signed and dated informed consent form 2. Child stated willingness to comply with all study procedures and availability for the duration of the study 3. Any gender, aged 6 to 17 years 4. Stimulant naïve or willing to wash out of stimulant for 3 days (approximately 72 hours) prior to testing with biometric and performance devices (MindTension + TOVA) 5. ADHD Group: Diagnosed with symptoms consistent with ADHD as determined by Mini Kid + an ADHD-RS score of 1.5SD above mean for age and sex 6. Control group: No diagnosable disorder on the Mini kid, and an ADHD-RS score within 1SD of the mean for age and sex.
Exclusion criteria
1. Current use of psychotropic medications that cannot be washed out in 3 days (approximately 72 hours) 2. Known current seizure disorder (history of febrile seizure allowed). 3. Presence of specific devices (e.g., cardiac pacemaker) that may interfere with the MindTension monitor 4. IQ\<70 by clinician judgment 5. Meeting FULL criteria for current PTSD, GAD, MDD, or any lifetime diagnosis of ASD, Bipolar disorder, or psychotic disorder that was, in the opinion of the investigator, correctly obtained. May have symptoms of anxiety or dysthymia/depression not meeting criteria for a full disorder, or disorders such as simple phobia 6. Deaf or hearing impaired, since this will make it difficult to hear and respond to the auditory stimuli. 7. Inability to complete the assessments. 8. Any other concerns in the judgment of the PI.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | From the beginning of clinical assessment until the end of testing (approximately 1-2 days). | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Positive Predicted Value (PPV) - conditional probability that the condition will be positive if the test is positive. | From the beginning of clinical assessment until the end of testing (approximately 1-2 days). | The outcome measure will be calculated using the following formula: Positive Predicted Value = (True Positive) / (True Positive + False Positive) X 100 |
| Negative Predicted Value (NPV) - conditional probability that the condition will be normal if the test is normal. | From the beginning of clinical assessment until the end of testing (approximately 1-2 days). | The outcome measure will be calculated using the following formula: Negative Predicted Value = (True Negative) / (True Negative + False Negative) X 100 |
| Sensitivity - conditional probability that the test will be positive if the condition is positive. | From the beginning of clinical assessment until the end of testing (approximately 1-2 days). | The outcome measure will be calculated using the following formula: Sensitivity = (True Positive) / (True Positive + False Negative) X 100 |
| Specificity - conditional probability that the test will be normal if the condition is normal. | From the beginning of clinical assessment until the end of testing (approximately 1-2 days). | The outcome measure will be calculated using the following formula: Specificity = (True Negative) / (True Negative + False Positive) X 100 |
Countries
United States
Contacts
Primary ContactJeffrey Newcorn, MD Professor
Backup ContactBeth Krone, PhD, MS
Outcome results
None listed