Normative Data of Brain Network Activation in Adolescents and Young Adults

Healthy Controls Clinical Trial

Official title:

Establishment of Normative Data of Brain Network Activation (BNA) Using Evoked Response Potentials in Adolescents and Young Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01671761
• Other study ID #: ELM-19
• Status: Completed
• Phase: N/A
• First received: August 21, 2012
• Last updated: April 8, 2015
• Start date: August 2012
• Est. completion date: July 2014

Study information

• Verified date: April 2015
• Source: ElMindA Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: July 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 15 Years to 24 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Healthy Controls

Locations

Country	Name	City	State
United States	Clinilabs, Inc.	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
ElMindA Ltd

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional networks of brain activity in healthy individuals measured using analysis of EEG Event Related Potential (ERP) data	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	1 year	No