A Comparative Study to Evaluate a Novel Algorithm As a Diagnostic Aid for ADHD in Youth Ages 6-17.
NCT ID: NCT06728969
Last Updated: 2024-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
120 participants
INTERVENTIONAL
2024-06-02
2026-06-30
Brief Summary
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Detailed Description
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Further to the above, demonstrate that the agreement between the MT1 output and the specialist clinician diagnosis will be non-inferior to the level of agreement between the clinician diagnosis with the Test of Visual Attention (TOVA) FDA cleared device.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
Following the specialist clinician assessment each subject will undergo a test using the FDA cleared T.O.V.A and MindTension's MT1.
DIAGNOSTIC
NONE
Study Groups
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ADHD group
Subjects will be evaluated for ADHD using clinically established reference standard interviews and psychometric tools with demonstrated validity, including the K-SADS and ADHD-RS-5, in accordance with DSM-5 criteria. IQ will be estimated using two subtests of the WASI.
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.
Non-ADHD group
Subjects will be evaluated using clinically established reference standard interviews and psychometric tools with demonstrated validity, including the K-SADS and ADHD-RS-5, in accordance with DSM-5 criteria. IQ will be estimated using two subtests of the WASI.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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.
6 Years
17 Years
ALL
Yes
Sponsors
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MindTension
INDUSTRY
Responsible Party
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Principal Investigators
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Jeffrey Newcorn, MD Professor
Role: PRINCIPAL_INVESTIGATOR
Director, Division of ADHD and Learning Disorders Icahn School of Medicine at Mount Sinai
Locations
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Icahn School of Medicine at Mount Sinai
New York, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Beth Krone Clinical Psychologist, PhD., MS
Role: primary
Jeffrey Newcorn Director Division of ADHD and Learning Disorders; Director Ped, MD Professor
Role: backup
Beth Krone Assistant Professor of Psychiatry, PhD., MS
Role: backup
Other Identifiers
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2023-0000
Identifier Type: -
Identifier Source: org_study_id