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Clinical Trials in the USA / NCT06728969
Recruiting Not applicable

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

NCT06728969 · tracked via the Priya Life Science USA tracker
Sponsor
MindTension
Phase
Not applicable
Started
2024-06-02
Last updated
2024-12-11

Condition(s) studied

ADHD

Investigational drug(s) / intervention(s)

MT1 Auditory startle response patterns analysis algorithmT.O.V.A. Continuous Performance Test

MT1 Auditory startle response patterns analysis algorithm: Objective measurements of attention and inhibition.

T.O.V.A. Continuous Performance Test: Objective measurements of attention and inhibitory control.

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

Sex
ALL
Min age
6 Years
Max age
17 Years
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Icahn School of Medicine at Mount Sinai New York New York Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06728969 on ClinicalTrials.gov ↗ ← All trials in the USA