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Reference Database & Longitudinal Registry of the Normal and Pathological Aging Brain

Reference Database & Longitudinal Registry of the Normal and Pathological Aging Brain: Brain Network Activation Analysis (BNA™) for the Adult and Elderly Population Using Evoked Response Potentials

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02875496
Acronym
(BNA™)
Enrollment
2000
Registered
2016-08-23
Start date
2016-08-31
Completion date
2022-12-31
Last updated
2019-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging, Depression, Early Onset Alzheimer Disease, Mild Cognitive Impairment

Brief summary

Establishment of a BNA reference database for the Adult and Elderly Population. Hypothesis-generating study designed to collect data that will aid in future scientific and engineering exploration of correlations between clinical assessments and BNA scores. The results are primarily intended for scientific inquiry and engineering development purposes, and may be used in future regulatory submissions.

Detailed description

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.

Interventions

None listed

Sponsors

ElMindA Ltd
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
Yes

Inclusion criteria

For ALL arms: Inclusion Criteria: * Currently resides in The Villages community * Age 50-years and above. * Able to speak, read and understand English * Willingness to participate and able to give informed consent. * If corrected vision: only Glasses should be used during the study testing

Exclusion criteria

* Currently with lice or open wounds on scalp. * Any CNS neurologic disorder * Significant sensory deficits. * Use of a hearing aid that occupies the ear canal * Any neuropsychological disorders * History of special education * Substance abuse in the last 3 months * History of any clinically significant brain trauma as determined by the investigator. * Clinically diagnosed with a concussion in the past year. For Arm 1 Healthy Inclusion Criteria: * BDI score \<14 * Subjects Not meeting diagnostic criteria for MDD per the DSM IV-TR, * MMSE score ≥25

Design outcomes

Primary

MeasureTime frameDescription
Developing a BNA database for healthy aging population.2 yearsFunctional networks of brain activity in healthy aging individuals measured using analysis of EEG Event Related Potential (ERP) data Clinical assessments battery will be utilized in order to establish different sets of BNA database for age related pathology and healthy aging.

Countries

United States

Contacts

Primary ContactCarla VandeWeerd, PhD
research@thevillageshealth.com352-674-8859

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026