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NCT Number: NCT06728969

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

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.

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Key information

Conditions

ADHD Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Icahn School of Medicine at Mount Sinai

New York, 10029, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Parent provision of signed and dated informed consent form
  • Child stated willingness to comply with all study procedures and availability for the duration of the study
  • Any gender, aged 6 to 17 years
  • Stimulant naïve or willing to wash out of stimulant for 3 days (approximately 72 hours) prior to testing with biometric and performance devices (MindTension + TOVA)
  • ADHD Group: Diagnosed with symptoms consistent with ADHD as determined by Mini Kid + an ADHD-RS score of 1.5SD above mean for age and sex
  • Control group: No diagnosable disorder on the Mini kid, and an ADHD-RS score within 1SD of the mean for age and sex.

Exclusion criteria

  • Current use of psychotropic medications that cannot be washed out in 3 days (approximately 72 hours)
  • Known current seizure disorder (history of febrile seizure allowed).
  • Presence of specific devices (e.g., cardiac pacemaker) that may interfere with the MindTension monitor
  • IQ<70 by clinician judgment
  • Meeting FULL criteria for current PTSD, GAD, MDD, or any lifetime diagnosis of ASD, Bipolar disorder, or psychotic disorder that was, in the opinion of the investigator, correctly obtained. May have symptoms of anxiety or dysthymia/depression not meeting criteria for a full disorder, or disorders such as simple phobia
  • Deaf or hearing impaired, since this will make it difficult to hear and respond to the auditory stimuli.
  • Inability to complete the assessments.
  • Any other concerns in the judgment of the PI.

Treatment and study plan

MT1 Auditory startle response patterns analysis algorithm

Device

Objective measurements of attention and inhibition.

T.O.V.A. Continuous Performance Test

Device

Objective measurements of attention and inhibitory control.

Primary outcomes

  1. Overall Agreement Rate (OAR) - probability that the test will be normal and the condition is normal or positive and the condition is positive, out of all subjects.

    Time frame: From the beginning of clinical assessment until the end of testing (approximately 1-2 days).

    The outcome measure will be calculated by using the following formula:

    Over All Agreement = (True Positive + True Negative) / (True Positive + True Negative + False Positive + False Negative) X 100.

Secondary outcomes

  1. Positive Predicted Value (PPV) - conditional probability that the condition will be positive if the test is positive.

    Time frame: From the beginning of clinical assessment until the end of testing (approximately 1-2 days).

    The outcome measure will be calculated using the following formula:

    Positive Predicted Value = (True Positive) / (True Positive + False Positive) X 100

  2. Negative Predicted Value (NPV) - conditional probability that the condition will be normal if the test is normal.

    Time frame: From the beginning of clinical assessment until the end of testing (approximately 1-2 days).

    The outcome measure will be calculated using the following formula:

    Negative Predicted Value = (True Negative) / (True Negative + False Negative) X 100

  3. Sensitivity - conditional probability that the test will be positive if the condition is positive.

    Time frame: From the beginning of clinical assessment until the end of testing (approximately 1-2 days).

    The outcome measure will be calculated using the following formula:

    Sensitivity = (True Positive) / (True Positive + False Negative) X 100

  4. Specificity - conditional probability that the test will be normal if the condition is normal.

    Time frame: From the beginning of clinical assessment until the end of testing (approximately 1-2 days).

    The outcome measure will be calculated using the following formula:

    Specificity = (True Negative) / (True Negative + False Positive) X 100

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

MindTension

Industry

Registry information

Official study 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.

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 11, 2024
Registry last updated
Dec 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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