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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 : October 15, 2019
Sponsor:
Information provided by (Responsible Party):
ElMindA Ltd

Tracking Information
First Submitted Date October 16, 2011
First Posted Date October 26, 2011
Last Update Posted Date October 15, 2019
Study Start Date October 2011
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 25, 2011)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Normative Data of Brain Network Activation in Adolescents and Young Adults
Official Title 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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
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.
Condition Healthy Controls
Intervention Not Provided
Study Groups/Cohorts Healthy adolescents and young adults
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 11, 2019)
64
Original Estimated Enrollment
 (submitted: October 25, 2011)
60
Actual Study Completion Date April 2012
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 15 Years to 24 Years   (Child, Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01460394
Other Study ID Numbers ELM-02
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Yes
Responsible Party ElMindA Ltd
Study Sponsor ElMindA Ltd
Collaborators Not Provided
Investigators
Principal Investigator: Bradley D. Vince, D.O. Vince and Associates Clinical Research
PRS Account ElMindA Ltd
Verification Date October 2019