A Prospective Comparative Study to Evaluate a Novel Algorithm Using Data Derived from a Non-Invasive Digital Biomarker As a Diagnostic Aid for ADHD in Youth Ages 6-17.
MindTension
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.
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…
Eligibility
- Age range
- 6–17 years
- Sex
- All
- 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…
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.
Location
- Icahn School of Medicine at Mount SinaiNew York, New York