- ICH GCP
- US-Register für klinische Studien
- Klinische 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
Studienübersicht
Status
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Voraussichtlich)
Kontakte und Standorte
Studienkontakt
- Name: Carla VandeWeerd, PhD
- Telefonnummer: 352-674-8859
- E-Mail: research@thevillageshealth.com
Studienorte
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Florida
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The Villages, Florida, Vereinigte Staaten, 32162
- Rekrutierung
- The Villages Health
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Kontakt:
- Carla VanderWeerd, PhD
- Telefonnummer: 352-674-8859
- E-Mail: research@thevillageshealth.com
-
Hauptermittler:
- Jeffrey Lowenkron, MD
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Hauptermittler:
- Carla VanderWeerd, PhD
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
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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)
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Developing a BNA database for healthy aging population.
Zeitfenster: 2 years
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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.
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2 years
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Jeffrey Lowenkron, MD, Chief Medical Officer, The Villages Health
- Hauptermittler: Carla VandeWeerd, PhD, Director of Research, The Villages Health
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Voraussichtlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- ELM-26
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
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