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

MindTension · NCT06728969

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 6–17 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
120
US sites recruiting
1
Study start
June 2, 2024
Record last updated
December 11, 2024

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

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

Conditions: ADHD

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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.

Recruiting US locations

  • Icahn School of Medicine at Mount Sinai

    New York, NY 10029

    Site contact: Beth Krone Clinical Psychologist, PhD., MS · 212 241 8012 · beth.krone@mssm.edu

Study contacts (from the official record)

  • Jeffrey Newcorn, MD Professor · 212-659-8705 · jeffrey.newcorn@mssm.edu
  • Beth Krone, PhD, MS · 212 241 8012 · beth.krone@mssm.edu
A Comparative Study to Evaluate a Novel Algorithm As a Diagnostic… (NCT06728969) | Bored Studies