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

Last updated: December 6, 2024
Sponsor: MindTension
Overall Status: Active - Recruiting

Phase

N/A

Condition

Attention Deficit/hyperactivity Disorder (Adhd - Adults)

Treatment

MT1 Auditory startle response patterns analysis algorithm

T.O.V.A. Continuous Performance Test

Clinical Study ID

NCT06728969
2023-0000
  • Ages 6-17
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Parent provision of signed and dated informed consent form

  2. Child stated willingness to comply with all study procedures and availability forthe 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 72hours) 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

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 theMindTension 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 theinvestigator, correctly obtained. May have symptoms of anxiety ordysthymia/depression not meeting criteria for a full disorder, or disorders such assimple phobia

  6. Deaf or hearing impaired, since this will make it difficult to hear and respond tothe auditory stimuli.

  7. Inability to complete the assessments.

  8. Any other concerns in the judgment of the PI.

Study Design

Total Participants: 120
Treatment Group(s): 2
Primary Treatment: MT1 Auditory startle response patterns analysis algorithm
Phase:
Study Start date:
June 02, 2024
Estimated Completion Date:
June 30, 2026

Study 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.

Connect with a study center

  • Icahn School of Medicine at Mount Sinai

    New York, New York 10029
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.