An interventional study of Geriatric Assesment with neuropsychological test more specific on decision making and Functional RMI in Decision Making, Dementia and Aging, sponsored by Centre Hospitalier Universitaire de Besancon. Status unknown at 2 sites in 2 countries. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2021-08-23.
Sponsored by Centre Hospitalier Universitaire de Besancon · Not applicable, Interventional, and Diagnostic
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.
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:
These 2 neuroimaging techniques allowed a neuro-functional analysis of decision making, based on the realization of more specific tests, modelling decision making. Among these models, the Iowa Game Task and the Balloon Assessement Risk Task are frequently used.
Nevertheless, all these tests and explorations were conducted independently, and no studies have investigated the contribution of a neurofunctional approach to patient decision-making through complementary explorations in functional MRI and /or in EEG-HR as diagnostic tools as part of an overall gerontological evaluation of decision making ability.
The question that arises is therefore that of the development of diagnostic tools.
2,172 studies on the registry are indexed under Dementia; 540 are open to participants now.
This study's planned enrollment of 74 is below the median of 83 across 1,629 interventional studies indexed under Dementia.
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Exclusion Criteria:
After first consultation for diagnosis of neurodegenerative disorder : * Geriatric Assessment with specific neuropsychologic tests of decision making * fRMI * EEG High Resolution * Qualitative interview
Diagnostic Test: Geriatric Assesment with neuropsychological test more specific on decision making · Diagnostic Test: Functional RMI · Diagnostic Test: High Resolution EEG · Other: Qualitative interview
The following tests will be made : MoCA, FAB, TMT, Stroop-Victoria, JAT
With specific test of decision making (IGT) specially adapted to the population
With specific test of decision making (BART) specially adapted to the population
Qualitative semi-directed interviews with participants, their caregivers and their geriatrician to analyse everyday life decision making ability.
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
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 ".
Time frame: 1
Comparison between neuropsychological test and neurofunctional imaging
The results of the functional neuroimaging tests will be analyzed in comparison with the neuropsychological tests performed, to verify the correlation between the results of the neuropsychological tests of decision-making ability and the results of the neuroimaging tests, and thus to identify, among the battery of tests used, those that are the most discriminating in the evaluation of decision-making ability
Time frame: 1 day
Comparison between neurocognitive disorders stage and decision-making ability
The neuropsychological tests that will be carried out will allow to identify the stage of neurocognitive disorders in patients. These elements can be correlated with the analysis of decision-making abilities in order to demonstrate a correlation between neurocognitive disorders, their stage, and decision-making ability
Time frame: 1 day
Analysis of the implication of the decision-making ability in everyday life situation
Based on the semi-directed interviews, a qualitative analysis will be carried out to study the reality of everyday life situations where decision-making ability is mobilized. A particular focus will be made on the impact of neurocognitive disorders on aging in place, and thus on the decision to integrate a nursing home.
Time frame: 1 day
Plan to share: No
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Centre Hospitalier Universitaire de Besancon