Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2026-01-02 @ 3:22 AM
Study NCT ID:
NCT06728969
Status:
RECRUITING
Last Update Posted:
2024-12-11
First Post:
2024-11-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparative Study to Evaluate a Novel Algorithm As a Diagnostic Aid for ADHD in Youth Ages 6-17.
Sponsor:
MindTension
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: