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Completed

NCT Number: NCT03971994

Emotion and Attention in Alzheimer's Disease (ATEMMA)

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.

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Key information

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Grenoble University Hospital

La Tronche, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Facial expression recognition task

Behavioral

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.

Primary outcomes

  1. Classic recognition score

    Time frame: 1 hour

    Facial expression recognition score (%)

  2. Classic fixation time faces

    Time frame: 1 hour

    Fixation time on eyes as measured with eyetracking (ms)

  3. Fixation time scenes

    Time frame: 30 mn

    Fixation time on emotional scenes outside of MRI

  4. Classic fMRI activity

    Time frame: 2 hours

    fMRI activity in amygdala and emotional attention networks during face exploration and resting-state

Secondary outcomes

  1. Alternative recognition score

    Time frame: 1 hour

    Facial expression recognition score (%) during an alternative task designed to encourage focus on the eyes

  2. Alternative fixation time faces

    Time frame: 1 hour

    Fixation time on eyes as measured with eyetracking (ms) during this alternative task.

  3. Alternative fMRI activity

    Time frame: 2 hours

    fMRI activity in amygdala and emotional attention networks during this alternative task

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

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

Acronym: ATEMMA

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jun 3, 2019
Registry last updated
Jan 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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