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Sponsored by: |
Lexicor Medical Technology, LLC |
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Information provided by: | Lexicor Medical Technology, LLC |
ClinicalTrials.gov Identifier: | NCT00595751 |
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.
Condition |
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Attention Deficit Disorder With Hyperactivity |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Best Estimate Diagnosis Used to Evaluate EEG in Association With ADHD in a Multi-Site, Clinical Sample of Children and Adolescents |
Estimated Enrollment: | 300 |
Study Start Date: | December 2007 |
Study Completion Date: | June 2008 |
Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 6 Years to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
The study focuses on individuals who have consecutively presented to participating clinics with suspected attention and/or behavior concerns and would receive a clinician's comprehensive evaluation for ADHD. The study population includes male and female participants aged 6-17.99 years regardless of race, ethnicity, and socioeconomic origin. Because of inclusion of patients with consecutive presentation to provide a representative clinical sample, the exact numbers for sub-groups will not be controlled. The study population will include patients with comorbid conditions. The non-ADHD subgroup will include patients with other causes of attentional concerns, which may include other common psychiatric disorders, organic causes of attention problems (such as poor hearing, vision disturbances, remote head injury, substance abuse), and/or no diagnosis.
Inclusion Criteria:
Exclusion Criteria:
United States, Alabama | |
Harmonex | |
Dothan, Alabama, United States, 36303 | |
United States, Colorado | |
Indian Crest Pediatrics | |
Westminster, Colorado, United States, 80021 | |
United States, Georgia | |
Medical College of Georgia | |
Augusta, Georgia, United States, 30912 | |
Mercer University School of Medicine | |
Macon, Georgia, United States, 31207-0001 | |
United States, Louisiana | |
LSU, HSC | |
New Orleans, Louisiana, United States, 70118 | |
United States, New Jersey | |
Children's Specialized Hospital | |
Toms River, New Jersey, United States, 08755 | |
United States, New York | |
SUNY Upstate Medical University | |
Syracuse, New York, United States, 13210 | |
United States, Ohio | |
Rakesh Ranjan, MD & Associates | |
Beachwood, Ohio, United States, 44122 | |
United States, Oklahoma | |
Eminence Research, LLC | |
Oklahoma City, Oklahoma, United States, 73139 | |
Oklahoma University Child Study Center | |
Oklahoma City, Oklahoma, United States, 73177 |
Study Director: | Humberto Quintana, MD | LSU, HSC |
Study Chair: | Steve Snyder, Ph.D. | Lexicor Medical Technology, LLC |
Principal Investigator: | Humberto Quintana, MD | LSU, HSC |
Responsible Party: | Lexicor Medical Technology, LLC ( Howard Merry, President ) |
Study ID Numbers: | 004-1.6 |
Study First Received: | January 7, 2008 |
Last Updated: | July 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00595751 |
Health Authority: | United States: Institutional Review Board |
ADHD, Attention Deficit Hyperactivity Disorder |
Signs and Symptoms Attention Deficit Disorder with Hyperactivity Mental Disorders Mental Disorders Diagnosed in Childhood |
Neurologic Manifestations Attention Deficit and Disruptive Behavior Disorders Hyperkinesis Dyskinesias |
Nervous System Diseases |