Actively Recruiting
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
Led by MindTension · Updated on 2024-12-11
120
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the accuracy of the MT1 algorithm using the MindTension biometric sensor device as a tool to help healthcare providers diagnose ADHD in youth aged 6 to 17 years. The study compares the MT1 algorithm's results with a clinical diagnosis made by specialists using standardized interviews and rating scales based on DSM-5 criteria. This evaluation also compares the MT1 algorithm's agreement with clinician diagnosis to that of the FDA-cleared Test of Visual Attention (TOVA) device. Participants will undergo assessments using well-established interviews such as the K-SADS and ADHD-RS-5 rating scale, with IQ estimated by two subtests of the WASI. The study involves two groups: one diagnosed with ADHD and one without, both evaluated with the same clinical tools. The MT1 algorithm's output derived from the MindTension device will be compared to these clinical standards and the TOVA device. During the study, participants will complete the clinical assessments, rating scales, and biometric testing over approximately 1 to 2 days. Researchers will measure the overall agreement rate between the MT1 algorithm and clinical diagnosis, along with secondary measures like sensitivity, specificity, and predictive values. These outcomes will help determine how well the MT1 algorithm performs as a diagnostic aid for ADHD in youth.
CONDITIONS
Brief Title
A Comparative Study to Evaluate a Novel Algorithm As a Diagnostic Aid for ADHD in Youth Ages 6-17.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Parent provision of signed and dated informed consent form
- Child willing to comply with all study procedures and available for the study duration
- Any gender, aged 6 to 17 years
- Stimulant-naïve or willing to stop stimulant medication for 3 days before testing
- ADHD group: Diagnosed with symptoms consistent with ADHD and an ADHD-RS score 1.5 standard deviations above the mean for age and sex
- Control group: No diagnosable disorder and an ADHD-RS score within 1 standard deviation of the mean for age and sex
You will not qualify if you...
- Current use of psychotropic medications that cannot be stopped for 3 days before testing
- Known current seizure disorder (history of febrile seizure allowed)
- Presence of devices like cardiac pacemaker that may interfere with the MindTension monitor
- IQ below 70 by clinician judgment
- Full criteria for PTSD, generalized anxiety disorder, major depressive disorder, or lifetime diagnosis of autism spectrum disorder, bipolar disorder, or psychotic disorder
- Deaf or hearing impaired
- Unable to complete assessments
- Any other concerns judged by the principal investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 to 2 days
Participants undergo diagnostic assessments using the MT1 algorithm, the T.O.V.A. device, and clinical interviews to evaluate for ADHD.
1 to 2 visits (in-person)
Trial Site Locations
Total: 1 location
1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
Research Team
J
Jeffrey Newcorn, MD Professor
B
Beth Krone, PhD, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here