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Emotion and Attention in Alzheimer's Disease (ATEMMA) (ATEMMA)

14. januar 2022 opdateret af: University Hospital, Grenoble

Attentional Capture by Emotional Information in Alzheimer's Disease : an fMRI Study

The main purpose of this study is to investigate the existence of emotional attention impairments in Alzheimer's Disease, in correlation with amygdala and attention networks alterations. To this end, functional and structural neuroimaging will be used. A face expression recognition task, along with eyetracking, will be used to assess emotional attention impairments.

Studieoversigt

Status

Afsluttet

Betingelser

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

41

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

      • La Tronche, Frankrig
        • Grenoble University Hospital

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

18 år til 95 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Healthy volunteers :

    • Affiliation to social security
    • Medical examination before study participation
    • No contraindication to MRI
    • Informed consent signed
    • Young adults older than 18 years and younger than 40 years
    • Healthy old adults older than 65 years and younger than 95 years
    • Visual acuity allowing normal perception of stimuli or corrected to normal vision
  • Patients with Alzheimer's Disease :

    • Affiliation to social security
    • Medical examination before study participation
    • No contraindication to MRI
    • Informed consent signed
    • Patients with Alzheimer's Disease at mild or moderate stage (National Institute on Aging and Alzheimer's Association criteria), diagnosed at Grenoble CMRR (Centre Mémoire de Ressources et de Recherche)
    • Patients older than 65 years and younger than 95 years
    • MMSE (Mini-Mental State Examination) > 18/30
    • Ability to understand study instructions and give an informed consent
    • Visual acuity allowing normal perception of stimuli or corrected to normal vision

Exclusion Criteria:

  • Every participant having a vascular stent implanted less than 6 weeks before study
  • Every participant having a biomedical material implanted that is considered "unsafe" in the list: http://www.mrisafety.com/TheList_search.asp
  • Every acquisition procedure not respecting required conditions by the "conditional" usage in a participant having a biomedical material implanted that is considered "conditional" in the list: http://www.mrisafety.com/TheList_search.asp
  • Every subject having a biomedical material such as a cardiac, neuronal or sensorial stimulator (cochlear implant because of demagnetization, electrode heating or artefact risk) or a ventricular drain without trained medical or paramedical support during MRI for these participants
  • Ferromagnetic object inside the eye or the skull, close to nervous structures (displacement and complications risk such as eye or brain damage)
  • Claustrophobia
  • Psychiatric (e.g., bipolar disorder) or neurological pathology (e.g., epilepsy, Parkinson's Disease) other than Alzheimer's Disease
  • Non cooperating participant
  • Severe and uncontrolled affection: cardiac, respiratory, haematological, renal, hepatic, cancerous
  • Participation to other research protocols with exclusion period or MRI during the past weel
  • Drug therapy likely to modulate brain activity : neuroleptics, lithium, etc...
  • Alcohol ingestion before study
  • Participants concerned by articles L1125-5 to L1121-8 of CSP (Code de la Santé Publique) (pregnant or nursing women, underage or protected adult, person under administrative or judicial oversight
  • Participant receiving more than 4500 euros for his participation to other studies involving human person during the past 12 months before this study
  • Participant unable to be contacted in case of emergency
  • Inability to understand study instructions or give an informed consent

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Young adults
Participants aged between 18 and 40 years old.
We will present emotional expressions to participants. Their task will be to determine which emotion is expressed by each face. Participants' eye movements and brain activity will be recorded while they explore the face.
Aktiv komparator: Healthy old adults
Participants aged between 65 and 95 years old.
We will present emotional expressions to participants. Their task will be to determine which emotion is expressed by each face. Participants' eye movements and brain activity will be recorded while they explore the face.
Eksperimentel: Patients with Alzheimer's Disease
Participants aged between 65 and 95 years old with a diagnosis of Alzheimer's Disease.
We will present emotional expressions to participants. Their task will be to determine which emotion is expressed by each face. Participants' eye movements and brain activity will be recorded while they explore the face.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Classic recognition score
Tidsramme: 1 hour
Facial expression recognition score (%)
1 hour
Classic fixation time faces
Tidsramme: 1 hour
Fixation time on eyes as measured with eyetracking (ms)
1 hour
Fixation time scenes
Tidsramme: 30 mn
Fixation time on emotional scenes outside of MRI
30 mn
Classic fMRI activity
Tidsramme: 2 hours
fMRI activity in amygdala and emotional attention networks during face exploration and resting-state
2 hours

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Alternative recognition score
Tidsramme: 1 hour
Facial expression recognition score (%) during an alternative task designed to encourage focus on the eyes
1 hour
Alternative fixation time faces
Tidsramme: 1 hour
Fixation time on eyes as measured with eyetracking (ms) during this alternative task.
1 hour
Alternative fMRI activity
Tidsramme: 2 hours
fMRI activity in amygdala and emotional attention networks during this alternative task
2 hours

Samarbejdspartnere og efterforskere

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

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 (Faktiske)

31. maj 2019

Primær færdiggørelse (Faktiske)

30. november 2021

Studieafslutning (Faktiske)

30. november 2021

Datoer for studieregistrering

Først indsendt

27. maj 2019

Først indsendt, der opfyldte QC-kriterier

31. maj 2019

Først opslået (Faktiske)

3. juni 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. januar 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. januar 2022

Sidst verificeret

1. januar 2022

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 2018/113
  • 2018-A02945-50 (Anden identifikator: ID RCB)

Plan for individuelle deltagerdata (IPD)

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