Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

25. november 2019 opdateret af: 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.

Studieoversigt

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

2000

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Florida
      • The Villages, Florida, Forenede Stater, 32162
        • Rekruttering
        • The Villages Health
        • Kontakt:
        • Ledende efterforsker:
          • Jeffrey Lowenkron, MD
        • Ledende efterforsker:
          • Carla VanderWeerd, PhD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

50 år til 85 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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:

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Developing a BNA database for healthy aging population.
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. august 2016

Primær færdiggørelse (Forventet)

1. august 2022

Studieafslutning (Forventet)

1. december 2022

Datoer for studieregistrering

Først indsendt

4. august 2016

Først indsendt, der opfyldte QC-kriterier

17. august 2016

Først opslået (Skøn)

23. august 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

27. november 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. november 2019

Sidst verificeret

1. november 2019

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Depression

Abonner