NCT03971994已完成不适用
Attentional Capture by Emotional Information in Alzheimer's Disease : an fMRI Study
University Hospital, Grenoble1 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2019年5月31日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Classic fMRI activity
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Classic fMRI activity
时间窗: 2 hours
fMRI activity in amygdala and emotional attention networks during face exploration and resting-state
Classic recognition score
时间窗: 1 hour
Facial expression recognition score (%)
Fixation time scenes
时间窗: 30 mn
Fixation time on emotional scenes outside of MRI
Classic fixation time faces
时间窗: 1 hour
Fixation time on eyes as measured with eyetracking (ms)
次要结局
- Alternative fixation time faces(1 hour)
- Alternative recognition score(1 hour)
- Alternative fMRI activity(2 hours)
研究者
研究点 (1)
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