Normative Data of Brain Network Activation in Adolescents and Young Adults
| Tracking Information | |||||
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| First Received Date ICMJE | October 16, 2011 | ||||
| Last Updated Date | August 20, 2012 | ||||
| Start Date ICMJE | October 2011 | ||||
| Primary Completion Date | April 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Functional networks of brain activity in healthy individuals measured using analysis of EEG Event Related Potential (ERP) data [ Time Frame: 1 week ] [ Designated as safety issue: No ] The study outcome measure are functional networks of brain activity of healthy adolescents (age 15-18 years) and young adults (19-24 years) established based on an analysis of EEG data recorded while study subjects perform ERP tasks |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01460394 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Normative Data of Brain Network Activation in Adolescents and Young Adults | ||||
| Official Title ICMJE | Establishment of Normative Data of Brain Network Activation (BNA) Using Evoked Response Potentials in Adolescents and Young Adults | ||||
| Brief Summary | Establish normative data of ElMindA's Brain Network Activation (BNA) using evoked response in two age groups: adolescents and young adults. |
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| Detailed Description | Currently, there is no reliable, practical, and non-invasive method for assessing changes in electrophysiological activity of the brain associated with brain-related pathologies, e.g., concussion, ADHD, autistic spectrum disorders (ASD), etc. Event Related Potentials (ERPs), which are temporal reflections of the neural mass electrical activity of cells in specific regions of the brain that occur in response to stimuli, may offer such a method, as they provide both a noninvasive and portable measure of brain function. The ERPs provide excellent temporal information, but spatial resolution for ERPs has traditionally been limited. However, by using high-density electroencephalograph (EEG) recording spatial resolution for ERPs is improved significantly. The paradigm for the current study will combine neurophysiological knowledge with mathematical signal processing and pattern recognition methods (BNA) to temporally and spatially map brain function, connectivity and synchronization. The need of objective measures that will help the clinician in its decision making in brain-related pathologies is recognized. BNA is a new imaging modality that has been developed to fill this gap. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Experimental subjects will include males and females recruited from the Kansas City metropolitan area, Vince & Associates Clinical Research's database and from referrals. |
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| Condition ICMJE | Healthy Controls | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Healthy adolescents and young adults | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 71 | ||||
| Completion Date | April 2012 | ||||
| Primary Completion Date | April 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 15 Years to 24 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01460394 | ||||
| Other Study ID Numbers ICMJE | ELM-02 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | ElMindA Ltd | ||||
| Study Sponsor ICMJE | ElMindA Ltd | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | ElMindA Ltd | ||||
| Verification Date | August 2012 | ||||
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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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