Normative Data of Brain Network Activation in Adolescents and Young Adults

NCT01671761 | Completed

• 1 other identifier: ELM-19
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Controls

Keywords

Healthy; Control

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

young adults

19-24 years old

adolescents

15-18 years old

Eligibility Criteria

• Age: 15 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• ElMindA Ltd: lead

Study Sites (1)

Clinilabs, Inc.

New York, New York, 10019, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2012
• First Posted: August 24, 2012
• Study Start: August 1, 2012
• Primary Completion: April 1, 2014
• Study Completion: July 1, 2014
• Last Updated: April 9, 2015

Record last verified: 2015-04

Locations

US (1)