Normative Data of Brain Network Activation in Adolescents and Young Adults

NCT01460394 | Completed

• 1 other identifier: ELM-02
• Study Type: observational
• Target: 64
• 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 week

Study Arms (1)

Healthy adolescents and young adults

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 Kansas City metropolitan area, Vince \& Associates Clinical Research's database and from referrals.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• ElMindA Ltd: lead

Study Sites (1)

Vince and Associates Clinical Research

Overland Park, Kansas, 66212, United States

Location

Study Officials

• Bradley D. Vince, D.O.

  Vince and Associates Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 16, 2011
• First Posted: October 26, 2011
• Study Start: October 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: October 15, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)