A Comparative Study to Evaluate a Novel Algorithm As a Diagnostic Aid for ADHD in Youth Ages 6-17.

Part of paid clinical trials in New York, New York.

Sponsor
MindTension
Study ID
NCT06728969
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
6 Years - 17 Years
Healthy Volunteers
Accepted

Interventions

  • MT1 Auditory startle response patterns analysis algorithm — DEVICE
    Objective measurements of attention and inhibition.
  • T.O.V.A. Continuous Performance Test — DEVICE
    Objective measurements of attention and inhibitory control.

Study Details

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 Dates

Start date
Jun 2, 2024
Status verified
Nov 2024
Primary completion
Jan 31, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
120 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: 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.
  • Experimental: 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.

Primary Outcome Measure

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. [ Time Frame: From the beginning of clinical assessment until the end of testing (approximately 1-2 days). ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Icahn School of Medicine at Mount SinaiNew YorkNew York10029
Beth Krone Clinical Psychologist, PhD., MS
[email protected]
212 241 8012
Jeffrey Newcorn Director Division of ADHD and Learning Disorders; Director Ped, MD Professor
Beth Krone Assistant Professor of Psychiatry, PhD., MS

Find similar trials in New York, NY

By condition
ADHD
By specialty
PsychiatryMental healthBehavioral health
By research site
Icahn School of Medicine at Mount Sinai· New York, NY

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