- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT02875496
Reference Database & Longitudinal Registry of the Normal and Pathological Aging Brain ((BNA™))
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
Přehled studie
Postavení
Detailní popis
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.
Typ studie
Zápis (Očekávaný)
Kontakty a umístění
Studijní místa
-
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Florida
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The Villages, Florida, Spojené státy, 32162
- Nábor
- The Villages Health
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Kontakt:
- Carla VanderWeerd, PhD
- Telefonní číslo: 352-674-8859
- E-mail: research@thevillageshealth.com
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Vrchní vyšetřovatel:
- Jeffrey Lowenkron, MD
-
Vrchní vyšetřovatel:
- Carla VanderWeerd, PhD
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
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
Exclusion Criteria:
- Any chronic disease or condition which affects the nervous system as determined by clinical neurological evaluation, medical history or PI discretion.
- Any psychiatric disorder,
- History of any medication affecting CNS within the last 3 months
For Arm 2 Early Alzheimer's Disease
Inclusion Criteria:
- BDI score <14
- Subjects Not meeting diagnostic criteria for MDD per the DSM IV-TR, as determined by clinical evaluation by a research clinician and the Mini International Neuropsychiatric Interview (MINI).
- MMSE score <24
- MoCA<20
- Presence of an early and significant episodic memory impairment
Exclusion Criteria:
- Any chronic disease or condition other than current pathology
- Any other psychiatric disorder
- CNS medications within the short period of time prior to the EEG testing which are not in a medically stable treatment phase.
For Arm 3 Depression
Inclusion Criteria:
- BDI score >14
- Subjects meeting full diagnostic criteria for MDD without psychotic features per the DSM IV-TR
- HAM-D 17-item: Total score of 16 or higher at visit 1.
Exclusion Criteria:
- Any chronic disease or condition other than current pathology
- Any psychiatric disorder other than Depression
- CNS medications within the short period of time prior to the EEG testing which are not in a medically stable treatment phase.
For Arm 4 Mild Cognitive Impairment
Inclusion Criteria:
- BDI score <14
- Subjects Not meeting diagnostic criteria for MDD per the DSM IV-TR
- MMSE scores according to Number of years of Education:
MMSE score Years of Education 17-18 ≤6 20-21 7-8 23-24 ≥10
-20<MoCA score >26
Exclusion Criteria:
- Any chronic disease or condition other than current pathology
- Any other psychiatric disorder
- CNS medications within the short period of time prior to the EEG testing which are not in a medically stable treatment phase.
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
|---|
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Healthy aging
Subjects meeting criteria for healthy aging No intervention administered
|
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Early Alzheimer Disease
Subjects meeting criteria for Early Alzheimer Disease No intervention administered
|
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Depression
Subjects meeting criteria for Depression No intervention administered
|
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MCI-Mild Cognitive Impairment
Subjects meeting criteria for MCI-Mild Cognitive Impairment No intervention administered
|
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General Arm
Subjects not meeting criteria for any of the other arms (Healthy, Early Alzheimer's, Depression, or MCI)
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Developing a BNA database for healthy aging population.
Časové okno: 2 years
|
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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Jeffrey Lowenkron, MD, Chief Medical Officer, The Villages Health
- Vrchní vyšetřovatel: Carla VandeWeerd, PhD, Director of Research, The Villages Health
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- ELM-26
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
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