Clinical Trials Directory

Trials / Completed

CompletedNCT00595751

NeuroLex EEG-Based ADHD Assessment Aid, Pivotal Study

Best Estimate Diagnosis Used to Evaluate EEG in Association With ADHD in a Multi-Site, Clinical Sample of Children and Adolescents

Status
Completed
Phase
Study type
Observational
Enrollment
300 (estimated)
Sponsor
Lexicor Medical Technology, LLC · Industry
Sex
All
Age
6 Years – 18 Years
Healthy volunteers
Not accepted

Summary

The study will evaluate the effectiveness of a standardized EEG method with the intended clinical users in the intended clinical settings with the intended population (patients who would typically receive a clinician's evaluation for ADHD). Multiple sites will be examined to provide a sample of patients across numerous communities with different demographics. The goal is to evaluate if the predictive accuracy of EEG will not be inferior to that of a widely-used and extensively validated ADHD scale in the prediction of ADHD in the intended use population as evaluated by Best Estimate Diagnosis.

Conditions

Timeline

Start date
2007-12-01
Primary completion
2008-06-01
Completion
2008-06-01
First posted
2008-01-16
Last updated
2008-07-30

Locations

10 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00595751. Inclusion in this directory is not an endorsement.