Trials / Recruiting
RecruitingNCT06728969
A Comparative Study to Evaluate a Novel Algorithm As a Diagnostic Aid for ADHD in Youth Ages 6-17.
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.
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- Sponsor
- MindTension · Industry
- Sex
- All
- Age
- 6 Years – 17 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | MT1 Auditory startle response patterns analysis algorithm | Objective measurements of attention and inhibition. |
| DEVICE | T.O.V.A. Continuous Performance Test | Objective measurements of attention and inhibitory control. |
Timeline
- Start date
- 2024-06-02
- Primary completion
- 2026-01-01
- Completion
- 2026-06-01
- First posted
- 2024-12-11
- Last updated
- 2024-12-11
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06728969. Inclusion in this directory is not an endorsement.