NeuroLex EEG-Based ADHD Assessment Aid, Pivotal Study (NEBA)

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

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.

Study Overview

• Status: Completed
• Conditions: Attention Deficit Disorder With Hyperactivity

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Dothan, Alabama, United States, 36303
      • Harmonex
  • Colorado
    • Westminster, Colorado, United States, 80021
      • Indian Crest Pediatrics
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Medical College of Georgia
    • Macon, Georgia, United States, 31207-0001
      • Mercer University School of Medicine
  • Louisiana
    • New Orleans, Louisiana, United States, 70118
      • LSU, HSC
  • New Jersey
    • Toms River, New Jersey, United States, 08755
      • Children's Specialized Hospital
  • New York
    • Syracuse, New York, United States, 13210
      • Suny Upstate Medical University
  • Ohio
    • Beachwood, Ohio, United States, 44122
      • Rakesh Ranjan, MD & Associates
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73139
      • Eminence Research, LLC
    • Oklahoma City, Oklahoma, United States, 73177
      • Oklahoma University Child Study Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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).

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
'Best Estimate Diagnosis' of ADHD applied in the intended population in settings with the intended users	At prensentation to clinic with attention or behavior problems

Collaborators and Investigators

• Sponsor: Lexicor Medical Technology, LLC
• Investigators: Study Director: Humberto Quintana, MD, LSU, HSC; Study Chair: Steve Snyder, Ph.D., Lexicor Medical Technology, LLC; Principal Investigator: Humberto Quintana, MD, LSU, HSC

Study record dates

Study Major Dates

• Study Start: December 1, 2007
• Primary Completion (ACTUAL): June 1, 2008
• Study Completion (ACTUAL): June 1, 2008

Study Registration Dates

• First Submitted: January 7, 2008
• First Submitted That Met QC Criteria: January 15, 2008
• First Posted (ESTIMATE): January 16, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): July 30, 2008
• Last Update Submitted That Met QC Criteria: July 29, 2008
• Last Verified: July 1, 2008

More Information

Terms related to this study

• Keywords: ADHD, Attention Deficit Hyperactivity Disorder
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity; Hyperkinesis
• Other Study ID Numbers: 004-1.6