A Comparative Study to Evaluate a Novel Algorithm As a Diagnostic Aid for ADHD in Youth Ages 6-17.
Recruiting now · Not applicable
Conditions studied: ADHD
In brief
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.
Key facts
- Study ID
- NCT06728969
- Run by
- MindTension
- People needed
- 120
- Starts
- 2024-06-02
- Expected to finish
- 2026-06-01
- Last updated by the study team
- 2024-12-11
Who can join
Age: 6 and older, up to 17. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Icahn School of Medicine at Mount Sinai — New York, New York, United States (enrolling)
Full record on ClinicalTrials.gov
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