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

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.

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.

Study Overview

• Status: Recruiting
• Conditions: ADHD
• Intervention / Treatment: Device: MT1 Auditory startle response patterns analysis algorithm; Device: T.O.V.A. Continuous Performance Test

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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jeffrey Newcorn, MD Professor; Phone Number: 212-659-8705; Email: jeffrey.newcorn@mssm.edu
• Study Contact Backup: Name: Beth Krone, PhD, MS; Phone Number: 212 241 8012; Email: beth.krone@mssm.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Recruiting
      • Icahn School Of Medicine At Mount Sinai
      • Contact: Beth Krone Clinical Psychologist, PhD., MS; Phone Number: 212 241 8012; Email: beth.krone@mssm.edu
      • Contact: Jeffrey Newcorn Director Division of ADHD and Learning Disorders; Director Ped, MD Professor
      • Contact: Beth Krone Assistant Professor of Psychiatry, PhD., MS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Parent provision of signed and dated informed consent form
2. Child stated willingness to comply with all study procedures and availability for the duration of the study
3. Any gender, aged 6 to 17 years
4. 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)
5. 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
6. 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:

1. Current use of psychotropic medications that cannot be washed out in 3 days (approximately 72 hours)
2. Known current seizure disorder (history of febrile seizure allowed).
3. Presence of specific devices (e.g., cardiac pacemaker) that may interfere with the MindTension monitor
4. IQ<70 by clinician judgment
5. 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
6. Deaf or hearing impaired, since this will make it difficult to hear and respond to the auditory stimuli.
7. Inability to complete the assessments.
8. Any other concerns in the judgment of the PI.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ADHD group; 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; Objective measurements of attention and inhibition.; Device: T.O.V.A. Continuous Performance Test; Objective measurements of attention and inhibitory control.
Experimental: Non-ADHD group; 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; Objective measurements of attention and inhibition.; Device: T.O.V.A. Continuous Performance Test; Objective measurements of attention and inhibitory control.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive Predicted Value (PPV) - conditional probability that the condition will be positive if the test is positive.	The outcome measure will be calculated using the following formula: Positive Predicted Value = (True Positive) / (True Positive + False Positive) X 100	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.	The outcome measure will be calculated using the following formula: Negative Predicted Value = (True Negative) / (True Negative + False Negative) X 100	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.	The outcome measure will be calculated using the following formula: Sensitivity = (True Positive) / (True Positive + False Negative) X 100	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.	The outcome measure will be calculated using the following formula: Specificity = (True Negative) / (True Negative + False Positive) X 100	From the beginning of clinical assessment until the end of testing (approximately 1-2 days).

Collaborators and Investigators

• Sponsor: MindTension
• Investigators: Principal Investigator: Jeffrey Newcorn, MD Professor, Director, Division of ADHD and Learning Disorders Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2024
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: November 23, 2024
• First Submitted That Met QC Criteria: December 6, 2024
• First Posted (Estimated): December 11, 2024

Study Record Updates

• Last Update Posted (Estimated): December 11, 2024
• Last Update Submitted That Met QC Criteria: December 6, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2023-0000

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No