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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01460394
Other study ID # ELM-02
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 2011
Est. completion date April 2012

Study information

Verified date October 2019
Source ElMindA Ltd
Contact n/a
Is FDA regulated No
Health authority
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 64
Est. completion date April 2012
Est. primary completion date April 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 15 Years to 24 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Vince and Associates Clinical Research Overland Park Kansas

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 week
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