Normative Data of Brain Network Activation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01742858
Recruitment Status : Withdrawn (The study was halted due to logistical reasons.)
First Posted : December 6, 2012
Last Update Posted : April 1, 2016
Information provided by (Responsible Party):
ElMindA Ltd

Brief Summary:
Establish normative data of ElMindA's Brain Network Activation (BNA) using evoked response in three age groups.

Condition or disease
Healthy Controls

Detailed Description:

Currently, there is no reliable, bedside, and non-invasive method for assessing connectivity 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 non-invasive 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 Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Establishment of Normative Data of Brain Network Activation Analysis (BNA) Using Evoked Response Potentials, in Adolescents and Young Adults
Study Start Date : February 2013
Estimated Primary Completion Date : August 2013
Estimated Study Completion Date : August 2013

15-18 years old
Young adults I
19-24 years old
Young adults II
25-30 years old

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, 25-30 years) established based on an analysis of EEG data recorded while study subjects perform ERP tasks

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Ages Eligible for Study:   15 Years to 30 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 Eugene metropolitan area.

Inclusion Criteria:

  • Age 15-30 years.
  • Able to speak, read and understand English sufficiently to understand the nature of the study, and to allow completion of all study assessments.
  • 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 or open wounds on scalp.
  • Any chronic disease as determined by clinical evaluation and medical history.
  • Any psychiatric disorder, e.g., depression, bipolar disorder, schizophrenic disorder, etc. as determined by clinical evaluation and the Mini International Neuropsychiatric Interview (MINI)
  • Any CNS neurologic disorder, e.g., epilepsy, seizures, etc. as determined by clinical evaluation
  • 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 clinically significant brain trauma as determined by the investigator

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 identifier (NCT number): NCT01742858

United States, Oregon
Electrical Geodesics, Inc.
Eugene, Oregon, United States, 97403
Sponsors and Collaborators
ElMindA Ltd
Principal Investigator: Don Tucker, PhD Electrical Geodesics, Inc.

Responsible Party: ElMindA Ltd Identifier: NCT01742858     History of Changes
Other Study ID Numbers: ELM-07
First Posted: December 6, 2012    Key Record Dates
Last Update Posted: April 1, 2016
Last Verified: March 2016