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A Comparative Study to Evaluate a Novel Algorithm As a Diagnostic Aid for ADHD in Youth Ages 6-17.
RecruitingHealthy volunteers welcome
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.
Who can join
Ages 6 to 17 · All sexes · Healthy volunteers welcome
Full eligibility criteria
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.
About the study
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.
What is being tested
- MT1 Auditory startle response patterns analysis algorithm (device)
- T.O.V.A. Continuous Performance Test (device)
Sponsor: MindTension · Participants: 120 · Started: Jun 2, 2024
Contact the study team
- Jeffrey Newcorn, MD Professor · Phone: 212-659-8705
- Beth Krone, PhD, MS · Phone: 212 241 8012
Official record on ClinicalTrials.gov — NCT06728969
Locations in the U.S.
| New York | Icahn School of Medicine at Mount Sinai, New York |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.