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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy aging | Subjects meeting criteria for healthy aging No intervention administered | ||
| Early Alzheimer Disease | Subjects meeting criteria for Early Alzheimer Disease No intervention administered | ||
| Depression | Subjects meeting criteria for Depression No intervention administered | ||
| MCI-Mild Cognitive Impairment | Subjects meeting criteria for MCI-Mild Cognitive Impairment No intervention administered | ||
| General Arm | Subjects not meeting criteria for any of the other arms (Healthy, Early Alzheimer's, Depression, or MCI) |
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| Measure | Description | Time Frame |
|---|---|---|
| Developing a BNA database for healthy aging population. | Functional 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. | 2 years |
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For ALL arms:
Inclusion Criteria:
Exclusion Criteria:
For Arm 1 Healthy
Inclusion Criteria:
Exclusion Criteria:
For Arm 2 Early Alzheimer's Disease
Inclusion Criteria:
Exclusion Criteria:
For Arm 3 Depression
Inclusion Criteria:
Exclusion Criteria:
For Arm 4 Mild Cognitive Impairment
Inclusion Criteria:
MMSE score Years of Education 17-18 ≤6 20-21 7-8 23-24 ≥10
-20<MoCA score >26
Exclusion Criteria:
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Up to 2000 subjects, from both genders, aged 50- years and above will be recruited and stratified to age groups. Once enrollment reaches the below numbers for each age group, subjects will be statistically stratified and analyzed in 4 different Arms, one Normative and three Pathologies, according to a prospective statistical plan and based on the prevalence of common pathological conditions in each age group; this will be determined by analysis of the literature, analysis of study demographics and concomitant diseases, and on the PI and/or sponsor's discretion. Suggested enrollment numbers for the different age groups and different Arms are:
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carla VandeWeerd, PhD | Contact | 352-674-8859 | research@thevillageshealth.com |
| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Lowenkron, MD | Chief Medical Officer, The Villages Health | Principal Investigator |
| Carla VandeWeerd, PhD | Director of Research, The Villages Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Villages Health | Recruiting | The Villages | Florida | 32162 | United States |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D060825 | Cognitive Dysfunction |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |