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

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ClinicalTrials.gov Identifier: NCT00595751
Recruitment Status : Completed
First Posted : January 16, 2008
Last Update Posted : July 30, 2008
Information provided by:
Lexicor Medical Technology, LLC

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.

Condition or disease
Attention Deficit Disorder With Hyperactivity

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Best Estimate Diagnosis Used to Evaluate EEG in Association With ADHD in a Multi-Site, Clinical Sample of Children and Adolescents
Study Start Date : December 2007
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 'Best Estimate Diagnosis' of ADHD applied in the intended population in settings with the intended users [ Time Frame: At prensentation to clinic with attention or behavior problems ]

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00595751

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United States, Alabama
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
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
Sponsors and Collaborators
Lexicor Medical Technology, LLC
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Study Director: Humberto Quintana, MD LSU, HSC
Study Chair: Steve Snyder, Ph.D. Lexicor Medical Technology, LLC
Principal Investigator: Humberto Quintana, MD LSU, HSC
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Responsible Party: Howard Merry, President, Lexicor Medical Technology, LLC
ClinicalTrials.gov Identifier: NCT00595751    
Other Study ID Numbers: 004-1.6
First Posted: January 16, 2008    Key Record Dates
Last Update Posted: July 30, 2008
Last Verified: July 2008
Keywords provided by Lexicor Medical Technology, LLC:
ADHD, Attention Deficit Hyperactivity Disorder
Additional relevant MeSH terms:
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Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases