Normative Data of Brain Network Activation

NCT01742858 | Withdrawn

• 1 other identifier: ELM-07
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Establish normative data of ElMindA's Brain Network Activation (BNA) using evoked response in three age groups.

Conditions

Healthy Controls

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, 25-30 years) established based on an analysis of EEG data recorded while study subjects perform ERP tasks

  1 week

Study Arms (3)

Adolescents

15-18 years old

Young adults I

19-24 years old

Young adults II

25-30 years old

Eligibility Criteria

• Age: 15 Years - 30 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 Eugene metropolitan area.

You may qualify if:

• Age 15-30 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
• 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)

Electrical Geodesics, Inc.

Eugene, Oregon, 97403, United States

Location

Study Officials

• Don Tucker, PhD

  Electrical Geodesics, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 3, 2012
• First Posted: December 6, 2012
• Study Start: February 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: April 1, 2016

Record last verified: 2016-03

Locations

US (1)