跳至主要内容
临床试验/NCT03931148
NCT03931148Unknown不适用

Feasibility Study of the Interest of Functional Neuroimaging in Assessing Decision-making Capacity of Older People With Neurocognitive Disorders

Centre Hospitalier Universitaire de Besancon4 个研究点 分布在 2 个国家目标入组 74 人开始时间: 2020年1月5日最近更新:
适应症

试验速览

阶段
不适用
入组人数
74
试验地点
4
主要终点
Estimation of concordance/disordance between the standardized global gerontological evaluation and the objectification of the activation zones of prefrontal ventromedial and dorsolateral cortex by functional imaging

研究概览

简要总结

IMAGISION aims to explore, in a cohort of patients referred for geriatric consultation for neurocognitive evaluation, the contribution of functional neuroimaging (functional MRI and, if possible, high resolution EEG) to geriatric expertise, associated with the performance of a battery of neuropsychological tests in the evaluation of decision-making capacity.

详细描述

It is during aging of patients, especially those with polypathological disorders and in whom cognitive disorders appear, that the most complex and ethical questions arise. In this context, these patients are frequently referred to geriatric consultations or memory centres for a global assessment of their cognitive functions and life skills in order to optimize their care and anticipate their medical and medico-social future. The assessment of decision-making capacity is essential in this regard.

Nevertheless, there is no test that specifically explores this issue and, therefore, people's decision-making abilities may not be properly estimated and may prevent some patients from making decisions when they would be able to do so.

Thus, although the issue of decision-making has generally been explored from a neuropsychological perspective in many studies, there is no specific test or score for decision-making capacity, as it is a complex process. The question of decision-making capacity in complex situations is therefore addressed by a multiple analysis of many parameters, including different neuropsychological data, which are then synthesized by the clinician in a standardized geriatric assessment to get an idea, among other things, of the overall ability to make decisions.

Given the difficulty of this and the ethical and societal issue, the research question focuses on the contribution of neuroimaging technologies to the assessment of decision-making capacity.

In fact, several studies have explored the issue as part of the functional neuroimaging study. The investigators note, in particular:

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

盲法说明

Analyses of functional imaging results (MRI and/or EEG) will be carried out blindly from the results of the geriatric assessment of decision-making ability. The results between the geriatrician's assessment of decision-making ability and the results of functional imaging tests will then be compared.

入排标准

年龄范围
70 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • French speaker
  • Recent diagnosis of neurocognitive disorder
  • Agreed with the study

排除标准

  • Major depressive symptoms
  • MRI contraindication

结局指标

主要结局

Estimation of concordance/disordance between the standardized global gerontological evaluation and the objectification of the activation zones of prefrontal ventromedial and dorsolateral cortex by functional imaging

时间窗: 1

The cohort data will be compared between patients identified as " questionable ability " according to the clinical evaluation (reference) and the neuroimaging evaluation, in order to see if the imaging allows to reclassify patients as " able ". A 10 % diagnostic gain in expected. Concerning functional neuroimaging (Balloon Analog Risk Task): The lack of activation of specific brain areas during period of interest will be considered as "compatible with the ability to make decisions" on neuro-functional imaging, while patients who do not activate the ROIs in the same situation will be considered as "compatible with questionable decision-making ability". Concerning standardized geriatric assessment: At the end of the initial consultation, based on his clinical examination, interview and standardized neuropsychological assessment, the geriatrician will classify each patient either as " preserved decision-making ability " or " questionable decision-making ability ".

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Thomas TANNOU

University Hospital Practitioner

Centre Hospitalier Universitaire de Besancon

研究点 (4)

Loading locations...

相似试验