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Reference Database & Longitudinal Registry of the Normal and Pathological Aging Brain ((BNA™))

25 de noviembre de 2019 actualizado por: ElMindA Ltd

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

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.

Descripción general del estudio

Descripción detallada

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.

Tipo de estudio

De observación

Inscripción (Anticipado)

2000

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Florida
      • The Villages, Florida, Estados Unidos, 32162
        • Reclutamiento
        • The Villages Health
        • Contacto:
        • Investigador principal:
          • Jeffrey Lowenkron, MD
        • Investigador principal:
          • Carla VanderWeerd, PhD

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

50 años a 85 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

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:

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
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)

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Developing a BNA database for healthy aging population.
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Jeffrey Lowenkron, MD, Chief Medical Officer, The Villages Health
  • Investigador principal: Carla VandeWeerd, PhD, Director of Research, The Villages Health

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de agosto de 2016

Finalización primaria (Anticipado)

1 de agosto de 2022

Finalización del estudio (Anticipado)

1 de diciembre de 2022

Fechas de registro del estudio

Enviado por primera vez

4 de agosto de 2016

Primero enviado que cumplió con los criterios de control de calidad

17 de agosto de 2016

Publicado por primera vez (Estimar)

23 de agosto de 2016

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

27 de noviembre de 2019

Última actualización enviada que cumplió con los criterios de control de calidad

25 de noviembre de 2019

Última verificación

1 de noviembre de 2019

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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