Evaluating a New Digital Algorithm Using a Non-Invasive Sensor to Help Diagnose ADHD in Children and Teens Aged 6 to 17

What this Trial Is About

Researchers are evaluating the accuracy of the MT1 algorithm using the MindTension biometric sensor device as a tool to help healthcare providers diagnose ADHD in youth aged 6 to 17 years. The study compares the MT1 algorithms results with a clinical diagnosis made by specialists using standardized interviews and rating scales based on DSM-5 criteria. This evaluation also compares the MT1 algorithms agreement with clinician diagnosis to that of the FDA-cleared Test of Visual Attention TOVA device. Participants will undergo assessments using well-established interviews such as the K-SADS and ADHD-RS-5 rating scale, with IQ estimated by two subtests of the WASI. The study involves two groups one diagnosed with ADHD and one without, both evaluated with the same clinical tools. The MT1 algorithms output derived from the MindTension device will be compared to these clinical standards and the TOVA device. During the study, participants will complete the clinical assessments, rating scales, and biometric testing over approximately 1 to 2 days. Researchers will measure the overall agreement rate between the MT1 algorithm and clinical diagnosis, along with secondary measures like sensitivity, specificity, and predictive values. These outcomes will help determine how well the MT1 algorithm performs as a diagnostic aid for ADHD in youth.

A Comparative Study to Evaluate a Novel Algorithm As a Diagnostic Aid for ADHD in Youth Ages 6-17.