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.

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 17
Healthy Volunteers: t
View:

• Parent provision of signed and dated informed consent form

• Child stated willingness to comply with all study procedures and availability for the duration of the study

• Any gender, aged 6 to 17 years

• 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)

• 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

• Control group: No diagnosable disorder on the Mini kid, and an ADHD-RS score within 1SD of the mean for age and sex.

Locations
United States
New York
Icahn School of Medicine at Mount Sinai
RECRUITING
New York
Contact Information
Primary
Jeffrey Newcorn, MD Professor
jeffrey.newcorn@mssm.edu
212-659-8705
Backup
Beth Krone, PhD, MS
beth.krone@mssm.edu
212 241 8012
Time Frame
Start Date: 2024-06-02
Estimated Completion Date: 2026-06
Participants
Target number of participants: 120
Treatments
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.
Sponsors
Leads: MindTension

This content was sourced from clinicaltrials.gov