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Normative Data of Brain Network Activation in Adolescents and Young Adults

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ClinicalTrials.gov Identifier: NCT01460394
Recruitment Status : Completed
First Posted : October 26, 2011
Last Update Posted : April 1, 2016
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease
Healthy Controls

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.


Study Design

Study Type : Observational
Actual Enrollment : 71 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Establishment of Normative Data of Brain Network Activation (BNA) Using Evoked Response Potentials in Adolescents and Young Adults
Study Start Date : October 2011
Primary Completion Date : April 2012
Study Completion Date : April 2012
Groups and Cohorts

Group/Cohort
Healthy adolescents and young adults


Outcome Measures

Primary Outcome Measures :
  1. Functional networks of brain activity in healthy individuals measured using analysis of EEG Event Related Potential (ERP) data [ Time Frame: 1 week ]
    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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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.
Contacts and Locations

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): NCT01460394


Locations
United States, Kansas
Vince and Associates Clinical Research
Overland Park, Kansas, United States, 66212
Sponsors and Collaborators
ElMindA Ltd
Investigators
Principal Investigator: Bradley D. Vince, D.O. Vince and Associates Clinical Research
More Information

Responsible Party: ElMindA Ltd
ClinicalTrials.gov Identifier: NCT01460394     History of Changes
Other Study ID Numbers: ELM-02
First Posted: October 26, 2011    Key Record Dates
Last Update Posted: April 1, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by ElMindA Ltd:
Healthy
Control