Evaluating a new algorithm for diagnosing ADHD in youth aged 6 to 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 is testing a new tool that uses a special sensor to see if it can help doctors diagnose ADHD in kids and teens aged 6 to 17 more accurately than current methods.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 6 Years to 17 Years
• Sex: All
• Sponsor: MindTension (industry)
• Locations: 1 site (New York, New York)
• Trial ID: NCT06728969 on ClinicalTrials.gov

What this trial studies

This study aims to assess the accuracy of the MT1 algorithm, which utilizes the MindTension biometric sensor device, as a diagnostic aid for ADHD in children and adolescents aged 6 to 17. The MT1 algorithm's output will be compared to a gold standard clinical diagnosis made by specialists using the Kiddie SADS Present and Lifetime semi-structured interview and the ADHD-RS-5 rating scale. The study will also evaluate whether the agreement between the MT1 output and specialist diagnoses is non-inferior to that of the TOVA Continuous Performance Test. Participants will include both diagnosed ADHD patients and a control group without ADHD.

Who should consider this trial

Good fit: Ideal candidates are youth aged 6 to 17 who are either diagnosed with ADHD or are part of a control group without any diagnosable disorder.

Not a fit: Patients currently on psychotropic medications that cannot be washed out in 3 days or those with specific medical devices that interfere with the MindTension monitor may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more accurate and efficient method for diagnosing ADHD in youth.

How similar studies have performed: While the approach of using biometric sensors for ADHD diagnosis is innovative, similar studies have shown varying degrees of success, indicating a need for further validation.

Eligibility criteria

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.

Where this trial is running

New York, New York

• Icahn School of Medicine at Mount Sinai — New York, New York, United States (RECRUITING)

Study contacts

• Principal investigator: Jeffrey Newcorn, MD Professor — Director, Division of ADHD and Learning Disorders Icahn School of Medicine at Mount Sinai
• Study coordinator: Jeffrey Newcorn, MD Professor

Conditions: ADHD