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NeuroLex EEG-Based ADHD Assessment Aid, Pivotal Study (NEBA)
This study has been completed.
Study NCT00595751   Information provided by Lexicor Medical Technology, LLC
First Received: January 7, 2008   Last Updated: July 29, 2008   History of Changes

January 7, 2008
July 29, 2008
December 2007
June 2008   (final data collection date for primary outcome measure)
'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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00595751 on ClinicalTrials.gov Archive Site
 
 
 
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

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.

 
 
Observational
Cohort, Prospective
Attention Deficit Disorder With Hyperactivity
 
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
300
June 2008
June 2008   (final data collection date for primary outcome measure)

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).
Both
6 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00595751
Howard Merry, President, Lexicor Medical Technology, LLC
004-1.6
Lexicor Medical Technology, LLC
 
Study Director: Humberto Quintana, MD LSU, HSC
Study Chair: Steve Snyder, Ph.D. Lexicor Medical Technology, LLC
Principal Investigator: Humberto Quintana, MD LSU, HSC
Lexicor Medical Technology, LLC
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP