Actively Recruiting

Phase Not Applicable
Age: 6Years - 17Years
All Genders
Healthy Volunteers
NCT06728969

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

Led by MindTension · Updated on 2024-12-11

120

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 6Years - 17Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Parent provides signed and dated informed consent
  • Child is willing to comply with all study procedures and available for study duration
  • Any gender, aged 6 to 17 years
  • Stimulant naive or willing to stop stimulant medication for 3 days before testing
  • For ADHD group: Diagnosed with ADHD symptoms and ADHD-RS score 1.5 standard deviations above mean for age and sex
  • For control group: No diagnosable disorder and ADHD-RS score within 1 standard deviation of mean for age and sex
Not Eligible

You will not qualify if you...

  • Current use of psychotropic medications that cannot be stopped for 3 days
  • Known current seizure disorder (febrile seizure history allowed)
  • Presence of devices like cardiac pacemaker that interfere with MindTension monitor
  • IQ below 70 by clinician judgment
  • Full criteria for PTSD, GAD, MDD, or lifetime diagnosis of ASD, Bipolar disorder, or psychotic disorder
  • Deaf or hearing impaired
  • Unable to complete assessments
  • Any other concerns as judged by the principal investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Icahn School of Medicine at Mount Sinai

New York, New York, United States, 10029

Actively Recruiting

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Research Team

J

Jeffrey Newcorn, MD Professor

CONTACT

B

Beth Krone, PhD, MS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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