Normative Data of Brain Network Activation in Adolescents and Young Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ElMindA Ltd
ClinicalTrials.gov Identifier:
NCT01460394
First received: October 16, 2011
Last updated: August 20, 2012
Last verified: August 2012

October 16, 2011
August 20, 2012
October 2011
April 2012   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01460394 on ClinicalTrials.gov Archive Site
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Normative Data of Brain Network Activation in Adolescents and Young Adults
Establishment of Normative Data of Brain Network Activation (BNA) Using Evoked Response Potentials in Adolescents and Young Adults

Establish normative data of ElMindA's Brain Network Activation (BNA) using evoked response in two age groups: adolescents and young adults.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Experimental subjects will include males and females recruited from the Kansas City metropolitan area, Vince & Associates Clinical Research's database and from referrals.

Healthy Controls
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Healthy adolescents and young adults
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
71
April 2012
April 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 15-24 years.
  • Willingness to participate and able to give informed assent (child) and/or consent (parent for minors or adult 18+ years of age for self).

Exclusion Criteria:

  • Currently participate in a contact sport (e.g., football, hockey, soccer, rugby, lacrosse, martial arts).
  • Currently with lice, open wounds on scalp.
  • Any chronic disease.
  • Any psychiatric disorder, e.g., depression, bipolar disorder, schizophrenic disorder, etc.
  • Any CNS neurologic disorder, e.g., epilepsy, seizures, etc.
  • Any neuropsychological disorders, e.g.: ADHD, Autistic Spectrum Disorder (ASD), etc.
  • History of Special education, e.g., reading disorder (dyslexia), writing disorder (dysgraphia), math disorder (dyscalculia), nonverbal learning disorder.
  • History of any medication affecting CNS within the last 3 months, e.g., antidepressants, anticonvulsants, psychostimulants, first generation antihistamines, etc.
  • Substance abuse in the last 3 months.
  • Significant sensory deficits, e.g., deafness or blindness.
  • History of any brain trauma.
Both
15 Years to 24 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01460394
ELM-02
No
ElMindA Ltd
ElMindA Ltd
Not Provided
Principal Investigator: Bradley D. Vince, D.O. Vince and Associates Clinical Research
ElMindA Ltd
August 2012

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