Normative Data of Brain Network Activation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2013-02-28

Study Completion Date

2013-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Normative Data of Brain Network Activation in Adolescents and Young Adults

NCT01671761

Healthy Controls

COMPLETED

Normative Data of Brain Network Activation in Adolescents and Young Adults

NCT01460394

Healthy Controls

COMPLETED

Normative Data Base of Brain Network Activation (BNA) Using Evoked Response Potentials

NCT02418208

Normative

COMPLETED

Additional Post Hoc Analysis and Clinical Data Collection

NCT02860416

Neurological Observations

COMPLETED

Post Hoc Analysis and Clinical Data Collection for Subjects Tested With Brain Network Activation (BNA™) Technology

NCT03699514

Healthy Cognitive Impairment Neurological Disorder

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Currently, there is no reliable, bedside, and non-invasive method for assessing connectivity 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 non-invasive 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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Controls

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Adolescents

15-18 years old

No interventions assigned to this group

Young adults I

19-24 years old

No interventions assigned to this group

Young adults II

25-30 years old

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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).

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
* 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

Minimum Eligible Age

15 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes