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Normative Data of Brain Network Activation in Adolescents and Young Adults

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
ElMindA Ltd
ClinicalTrials.gov Identifier:
NCT01671761
First received: August 21, 2012
Last updated: August 13, 2013
Last verified: August 2013
  Purpose

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


Condition
Healthy Controls

Study Type: Observational
Study Design: 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

Further study details as provided by ElMindA Ltd:

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


Enrollment: 43
Study Start Date: August 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
young adults
19-24 years old
adolescents
15-18 years old

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.

  Eligibility

Ages Eligible for Study:   15 Years to 24 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Experimental subjects will include males and females recruited from the New York City metropolitan area, Clinilabs Ltd. Clinical Research's database and from referrals.

Criteria

Inclusion Criteria:

  • Age 15-24 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
  • Any neuropsychological disorders, e.g.: ADHD, Autistic Spectrum Disorder (ASD), 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01671761

Locations
United States, New York
Clinilabs, Inc.
New York, New York, United States, 10019
Sponsors and Collaborators
ElMindA Ltd
  More Information

No publications provided

Responsible Party: ElMindA Ltd
ClinicalTrials.gov Identifier: NCT01671761     History of Changes
Other Study ID Numbers: ELM-19
Study First Received: August 21, 2012
Last Updated: August 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by ElMindA Ltd:
Healthy
Control

ClinicalTrials.gov processed this record on November 19, 2014