The Interplay Between Emotional Processing and Self-Monitoring in Neurodegenerative Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- ELECTROPHYSIOLOGICAL AND ELECTRODERMAL MEASURES
研究概览
简要总结
The ASSESS project is a monocenter, regionally based, study evaluating the pathophysiological/functional processes underlying anosognosia in both AD and bvFTD. The multimodal analysis will be applied to the obtained cognitive, neuroimaging and electrophysiological data in order to describe the mechanistic cascade of anosognosia and their neuronal and electrophysiological biomarkers. Importantly, it has the potential to significantly impact society by: i) addressing a fundamental scientific question towards a causal understanding on how self-awareness emerges in the human brain; and ii) developing a cognitive BCI-system, which will allow us to validated neurophenomenologically EEG biomarkers in anosognosia, and may give us access in later steps to neurofeedback applications for the improvement of self-awareness in early stages of AD and bvFTD, with major social and economic gains.
详细描述
- INTRODUCTION The ability to appraise our own performance is a unique component of human functioning. It is impaired in brain diseases responsible for anosognosia, resulting in poor self-appraisal of one's own deficits. Anosognosia negatively impacts on capacity issues, such as treatment compliance and the patients' ability to deal appropriately with risk situations, with damaging consequences on their quality of life. Furthermore, it places a serious burden on the healthcare systems and may be extremely distressing for the patients' caregivers. Although initially described after vascular brain lesions and frequently observed in neurodegenerative disorders, such as the Alzheimer's disease (AD) or the behavioral variant of frontotemporal dementia (bvFTD), anosognosia remains an intriguing phenomenon and its neural mechanisms largely unknown. There is, however, evidence in neurodegenerative disorders pointing to frontally-mediated dysfunctions as causes of anosognosia. Here, we build on a convergence of emotional and self-monitoring processes, and specifically explore their role in the emergence of anosognosia in AD and bvFTD patients, thus predicting that unawareness across domains may depend on common processes. In particular, we hypothetize that anosognosia might result from the inability to establish the linkage between emotional arousal and self-monitoring (that would normally trigger adaptive behaviors), due to critical connectivity impairments in the uncinate fasciculus in both AD and bvFTD (regardless to the nature of the deficits to which the patients are unaware). Indeed, by virtue of its connectivity, linking limbic with frontal/executive systems, one might expect that the uncinate fasciculus plays a major role in the interplay between emotional arousal and self-monitoring.
- OBJECTIVES
The main scientific, clinical and technological objectives of this project are:
-
To test the interplay between self-monitoring and autonomic reactivity (as a proxy of emotional arousal) and then determine whether it is disturbed in both groups of patients relative to healthy controls, and whether it correlates with the patients' anosognosia level, as measured by standard scales (STUDY 1);
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To test whether structural and functional damage to the uncinate fasciculus correlate with the patients' anosognosia level, and whether it may be critical for the emergence of this neurological syndrome (STUDY 2); and
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To establish the neurophysiological markers of anosognosia in order to further develop a cognitive Brain-computer interface (BCI) aimed at monitoring patients' self-awareness in real time (STUDY 3).
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PROJECT IMPLEMENTATION
The current project will be implemented over three distinct periods, corresponding to 3 well-identified work packages (WPs), during 48 months: 1. Data Acquisition; 2. Data Analysis; and 3. BCI Application WPs, as follows:
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PATIENTS and HEALTHY CONTROLS :
- •French speakers*, age ≥ 50 ≤ 85 years of age, with normal color vision or corrected-tonormal visual acuity,
- •Capacity to consent,
- •Covered by social security,
- •Ability to undergo MRI scanning,
- •The spouse / caregiver is able to accompany the subject to both visits and ready to complete questionnaires.
- •Already in menopause (for women)
- •30 patients fulfilling the core diagnostic features of bvFTD; 30 patients fulfilling the core diagnostic features of AD; both in a mild to moderate cognitive and functional severity stage, as determined by: MMSE score greater than or equal to 18, and CDR global score less than or equal to 2, Grober et Buschke: TRGB < 42 as well as clinical signs (subjective impression) of anosognosia.
- •HEALTHY SUBJECTS (n=40) :
- •MMSE score ≥ 27;TRGB> 42 Education, gender-, and aged-matched controls. * Subjects will be administered neuropsychological tests that have been validated for French speakers.
排除标准
- •Illiteracy /unable to count or to read;
- •Having a neurological disorder, such as: epilepsy, extrapyramidal signs, brain tumour, subdural haematoma, history of head trauma followed by persistent neurological deficits (motor, sensory or cognitive); stroke that has occurred in the last three months;
- •Report of a present or prior major psychiatric disorder;
- •Potentially confounding medications, particularly beta-blockers that may have effects on the peripheral nervous system; typically, beta-blockers are used to control heart rhythm, treat angina, and reduce high blood pressure.
- •Person deprived of their liberty by judicial or administrative decision
- •Participation in a drug trial or exclusion period of another study
- •Inability to understand information about the protocol
- •Meeting brain MRI exclusion criteria (pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin, or body, claustrophobia) or refusing MRI. * Contra-indication questionnaire to be filled in beforehand.
结局指标
主要结局
ELECTROPHYSIOLOGICAL AND ELECTRODERMAL MEASURES
时间窗: 45 Minutes
Primary studied parameters include the measure of: i) A classic marker of brain responses to one's own errors, which can be measured by EEG (the so-called error-related negativity, ERN), regarding the individual variability and between-group differences in self-monitoring accuracy; ii) The ERN amplitude and latency, as indexes of self-monitoring ability, regarding subjects' emotional arousal, as studied by the amplitude of electrodermal responses (EDRs); iii) The ERN amplitude and latency, and the EDR amplitudes, regarding the level of anosognosia within the patients' groups.
次要结局
- NEUROIMAGING(45 minutes)