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

NCT06728969 | Recruiting FDA Device

• 1 other identifier: 2023-0000
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

ADHD

Outcome Measures

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.

  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.

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

Secondary Outcomes (4)

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

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

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

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

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

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

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

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

Study Arms (2)

ADHD group

EXPERIMENTAL

Subjects will be evaluated for ADHD using clinically established reference standard interviews and psychometric tools with demonstrated validity, including the K-SADS and ADHD-RS-5, in accordance with DSM-5 criteria. IQ will be estimated using two subtests of the WASI.

Device: MT1 Auditory startle response patterns analysis algorithm; Device: T.O.V.A. Continuous Performance Test

Non-ADHD group

EXPERIMENTAL

Subjects will be evaluated using clinically established reference standard interviews and psychometric tools with demonstrated validity, including the K-SADS and ADHD-RS-5, in accordance with DSM-5 criteria. IQ will be estimated using two subtests of the WASI.

Device: MT1 Auditory startle response patterns analysis algorithm; Device: T.O.V.A. Continuous Performance Test

Interventions

MT1 Auditory startle response patterns analysis algorithm DEVICE

Objective measurements of attention and inhibition.

ADHD group; Non-ADHD group

T.O.V.A. Continuous Performance Test DEVICE

Objective measurements of attention and inhibitory control.

ADHD group; Non-ADHD group

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MindTension: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Jeffrey Newcorn, MD Professor

  Director, Division of ADHD and Learning Disorders Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeffrey Newcorn, MD Professor

CONTACT

212-659-8705; jeffrey.newcorn@mssm.edu

Beth Krone, PhD, MS

CONTACT

212 241 8012; beth.krone@mssm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study will include a group of subjects who have ADHD and subjects who are healthy controls based on the specialist clinician assessment. Following the specialist clinician assessment each subject will undergo a test using the FDA cleared T.O.V.A and MindTension's MT1.

Study Record Dates

• First Submitted: November 23, 2024
• First Posted: December 11, 2024
• Study Start: June 2, 2024
• Primary Completion: January 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 11, 2024

Record last verified: 2024-11

Locations

US (1)