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

NCT06728969 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2024-12-11

No results posted yet for this study

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.

Conditions

  • ADHD

Interventions

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.

Sponsors & Collaborators

  • MindTension

    lead INDUSTRY

Principal Investigators

  • Jeffrey Newcorn, MD Professor · Director, Division of ADHD and Learning Disorders Icahn School of Medicine at Mount Sinai

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-02
Primary Completion
2026-01-31
Completion
2026-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06728969 on ClinicalTrials.gov