- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Statut
Description détaillée
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.
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Carla VandeWeerd, PhD
- Numéro de téléphone: 352-674-8859
- E-mail: research@thevillageshealth.com
Lieux d'étude
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Florida
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The Villages, Florida, États-Unis, 32162
- Recrutement
- The Villages Health
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Contact:
- Carla VanderWeerd, PhD
- Numéro de téléphone: 352-674-8859
- E-mail: research@thevillageshealth.com
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Chercheur principal:
- Jeffrey Lowenkron, MD
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Chercheur principal:
- Carla VanderWeerd, PhD
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Developing a BNA database for healthy aging population.
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Jeffrey Lowenkron, MD, Chief Medical Officer, The Villages Health
- Chercheur principal: Carla VandeWeerd, PhD, Director of Research, The Villages Health
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- ELM-26
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
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