RecruitingNot ApplicableNCT06728969
A Comparative Study to Evaluate a Novel Algorithm As a Diagnostic Aid for ADHD in Youth Ages 6-17.
A Prospective Comparative Study to Evaluate a Novel Algorithm Using Data Derived from a Non-Invasive Digital Biomarker As a Diagnostic Aid for ADHD in Youth Ages 6-17.
Sponsor
MindTension
Enrollment
120 participants
Start Date
Jun 2, 2024
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 6 YearsMax Age: 17 Years
Inclusion Criteria6
- 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 Criteria8
- 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.
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Interventions
DEVICEMT1 Auditory startle response patterns analysis algorithm
Objective measurements of attention and inhibition.
DEVICET.O.V.A. Continuous Performance Test
Objective measurements of attention and inhibitory control.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06728969
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