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| Tracking Information | |||||||||||||
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| First Received Date ICMJE | January 7, 2008 | ||||||||||||
| Last Updated Date | July 29, 2008 | ||||||||||||
| Start Date ICMJE | December 2007 | ||||||||||||
| Primary Completion Date | June 2008 (final data collection date for primary outcome measure) | ||||||||||||
| Current Primary Outcome Measures ICMJE |
'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 ] | ||||||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||
| Change History | Complete list of historical versions of study NCT00595751 on ClinicalTrials.gov Archive Site | ||||||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||||||
| Descriptive Information | |||||||||||||
| Brief Title ICMJE | NeuroLex EEG-Based ADHD Assessment Aid, Pivotal Study | ||||||||||||
| Official Title ICMJE | Best Estimate Diagnosis Used to Evaluate EEG in Association With ADHD in a Multi-Site, Clinical Sample of Children and Adolescents | ||||||||||||
| 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. |
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| Detailed Description | |||||||||||||
| Study Phase | |||||||||||||
| Study Type ICMJE | Observational | ||||||||||||
| Study Design ICMJE | Cohort, Prospective | ||||||||||||
| Condition ICMJE | Attention Deficit Disorder With Hyperactivity | ||||||||||||
| Intervention ICMJE | |||||||||||||
| Study Arms / Comparison Groups | |||||||||||||
| Publications * | |||||||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Completed | ||||||||||||
| Estimated Enrollment ICMJE | 300 | ||||||||||||
| Completion Date | June 2008 | ||||||||||||
| Primary Completion Date | June 2008 (final data collection date for primary outcome measure) | ||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||
| Ages | 6 Years to 18 Years | ||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
| Location Countries ICMJE | United States | ||||||||||||
| Administrative Information | |||||||||||||
| NCT ID ICMJE | NCT00595751 | ||||||||||||
| Responsible Party | Howard Merry, President, Lexicor Medical Technology, LLC | ||||||||||||
| Study ID Numbers ICMJE | 004-1.6 | ||||||||||||
| Study Sponsor ICMJE | Lexicor Medical Technology, LLC | ||||||||||||
| Collaborators ICMJE | |||||||||||||
| Investigators ICMJE |
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| Information Provided By | Lexicor Medical Technology, LLC | ||||||||||||
| Verification Date | July 2008 | ||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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