- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03971994
Emotion and Attention in Alzheimer's Disease (ATEMMA) (ATEMMA)
14 januari 2022 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
41
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
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La Tronche, Frankrike
- Grenoble University Hospital
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 95 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: Young adults
Participants aged between 18 and 40 years old.
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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.
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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.
|
|
Experimentell: Patients with Alzheimer's Disease
Participants aged between 65 and 95 years old with a diagnosis of Alzheimer's Disease.
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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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Classic recognition score
Tidsram: 1 hour
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Facial expression recognition score (%)
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1 hour
|
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Classic fixation time faces
Tidsram: 1 hour
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Fixation time on eyes as measured with eyetracking (ms)
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1 hour
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Fixation time scenes
Tidsram: 30 mn
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Fixation time on emotional scenes outside of MRI
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30 mn
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Classic fMRI activity
Tidsram: 2 hours
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fMRI activity in amygdala and emotional attention networks during face exploration and resting-state
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2 hours
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Alternative recognition score
Tidsram: 1 hour
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Facial expression recognition score (%) during an alternative task designed to encourage focus on the eyes
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1 hour
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Alternative fixation time faces
Tidsram: 1 hour
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Fixation time on eyes as measured with eyetracking (ms) during this alternative task.
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1 hour
|
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Alternative fMRI activity
Tidsram: 2 hours
|
fMRI activity in amygdala and emotional attention networks during this alternative task
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2 hours
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
31 maj 2019
Primärt slutförande (Faktisk)
30 november 2021
Avslutad studie (Faktisk)
30 november 2021
Studieregistreringsdatum
Först inskickad
27 maj 2019
Först inskickad som uppfyllde QC-kriterierna
31 maj 2019
Första postat (Faktisk)
3 juni 2019
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
18 januari 2022
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
14 januari 2022
Senast verifierad
1 januari 2022
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2018/113
- 2018-A02945-50 (Annan identifierare: ID RCB)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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