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
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
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)
- 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. — From the beginning of clinical assessment until the end of testing (approximately 1-2 days).
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.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | Recruiting |
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EndeavorOTC™ Prospective Product Registry
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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