Actively Recruiting
A Comparative Study to Evaluate a Novel Algorithm 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
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 provides signed and dated informed consent
- Child is willing to comply with all study procedures and available for study duration
- Any gender, aged 6 to 17 years
- Stimulant naive or willing to stop stimulant medication for 3 days before testing
- For ADHD group: Diagnosed with ADHD symptoms and ADHD-RS score 1.5 standard deviations above mean for age and sex
- For control group: No diagnosable disorder and ADHD-RS score within 1 standard deviation of mean for age and sex
You will not qualify if you...
- Current use of psychotropic medications that cannot be stopped for 3 days
- Known current seizure disorder (febrile seizure history allowed)
- Presence of devices like cardiac pacemaker that interfere with MindTension monitor
- IQ below 70 by clinician judgment
- Full criteria for PTSD, GAD, MDD, or lifetime diagnosis of ASD, Bipolar disorder, or psychotic disorder
- Deaf or hearing impaired
- Unable to complete assessments
- Any other concerns as judged by the principal investigator
AI-Screening
AI-Powered Screening
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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
CONTACT
B
Beth Krone, PhD, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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