Normative Data of Brain Network Activation in Adolescents and Young Adults

• ClinicalTrials.gov Identifier: NCT01460394
• Recruitment Status: Completed
• First Posted: October 26, 2011
• Last Update Posted: October 15, 2019
• Sponsor: ElMindA Ltd
• 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
• 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

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

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