NeuroLex EEG-Based ADHD Assessment Aid, Pivotal Study

NCT ID: NCT00595751

Last Updated: 2008-07-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2008-06-30

Brief 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

Attention Deficit Disorder With Hyperactivity

Keywords

ADHD, Attention Deficit Hyperactivity Disorder

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Subject willing to voluntarily participate in a research study that includes EEG collection and analysis.
• Family/patient seeking comprehensive clinical evaluation for attention and/or behavior concerns.
• Male or female at least 6 years of age and who will not be over 17.99 years of age upon admission to study.
• Willing to stop any and all current psychiatric medications prior to or by entry into study.
• Subject and parent (or legal representative) of an educational level and degree of understanding sufficient to communicate suitably with the investigator, rater and study coordinator.

Exclusion Criteria

• Previous diagnosis of mental retardation. IQ < 70 by previous records.
• History of seizure disorder or of EEG abnormalities. On anticonvulsants for seizure control.
• Metal plate or metal device in the head.
• Suicide ideation or gesture and/or homicidal ideation or gesture.
• Concomitant medications during participation in a research study. No prescription or nonprescription medications with psychoactive properties that may affect EEG (such as over-the-counter dietary supplements, pseudoephedrine, or phenylpropanolamine). No antipsychotics, no psychostimulants, no antidepressants. Washout of at least one week or longer depending on the medication and clinician's judgment. Medication used for medical reasons must be cleared by research staff with consideration of known effects on EEG.
• Known serious medical problems (cardiovascular, hematological, liver, seizure disorder, renal, or chronic respiratory problems).

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lexicor Medical Technology, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Lexicor Medical Technology, LLC

Principal Investigators

Humberto Quintana, MD

Role: STUDY_DIRECTOR

LSU, HSC

Steve Snyder, Ph.D.

Role: STUDY_CHAIR

Lexicor Medical Technology, LLC

Humberto Quintana, MD

Role: PRINCIPAL_INVESTIGATOR

LSU, HSC

Locations

Harmonex

Dothan, Alabama, United States

Indian Crest Pediatrics

Westminster, Colorado, United States

Medical College of Georgia

Augusta, Georgia, United States

Mercer University School of Medicine

Macon, Georgia, United States

LSU, HSC

New Orleans, Louisiana, United States

Children's Specialized Hospital

Toms River, New Jersey, United States

SUNY Upstate Medical University

Syracuse, New York, United States

Rakesh Ranjan, MD & Associates

Beachwood, Ohio, United States

Eminence Research, LLC

Oklahoma City, Oklahoma, United States

Oklahoma University Child Study Center

Oklahoma City, Oklahoma, United States

Countries

United States

Other Identifiers

004-1.6

Identifier Type: -

Identifier Source: org_study_id