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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03931148
Acronym
IMAGISION
Enrollment
74
Registered
2019-04-30
Start date
2020-01-05
Completion date
2023-04-30
Last updated
2021-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging, Decision Making, Dementia

Keywords

Neuroimaging, Dementia, Decision making, Neuropsychology, Aging

Brief summary

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.

Detailed description

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: * Decision-making studies were conducted using the EEG-High Resolution (EEG-HR) technique. It is a technique for electromagnetic analysis of brain functions with excellent temporal resolution and quite good spatial resolution. This allows, during functional decision tests, a detailed analysis of the temporality of the activation of the frontal and prefrontal areas. * Functional MRI (fMRI) is a neurological imaging technique whose main strength lies in its spatial acuity. Thus, the performance of functional decisional tests under functional MRI allows a detailed analysis of the recruitment of the different zones between the dorsolateral prefrontal cortex and the median ventromedian cortex. 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.

Interventions

DIAGNOSTIC_TESTGeriatric Assesment with neuropsychological test more specific on decision making

The following tests will be made : MoCA, FAB, TMT, Stroop-Victoria, JAT

DIAGNOSTIC_TESTFunctional RMI

With specific test of decision making (IGT) specially adapted to the population

DIAGNOSTIC_TESTHigh Resolution EEG

With specific test of decision making (BART) specially adapted to the population

OTHERQualitative interview

Qualitative semi-directed interviews with participants, their caregivers and their geriatrician to analyse everyday life decision making ability.

Sponsors

Université de Montréal
CollaboratorOTHER
Centre Hospitalier Universitaire de Besancon
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Masking description

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.

Eligibility

Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Delirium * Major depressive symptoms * MRI contraindication

Design outcomes

Primary

MeasureTime frameDescription
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 imaging1The 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 .

Other

MeasureTime frameDescription
Comparison between neuropsychological test and neurofunctional imaging1 dayThe 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
Comparison between neurocognitive disorders stage and decision-making ability1 dayThe 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
Analysis of the implication of the decision-making ability in everyday life situation1 dayBased 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.

Countries

Canada, France

Contacts

Primary ContactThomas TANNOU, MD
ttannou@chu-besancon.fr+33381669003
Backup ContactAurelie MARCEAU, PhD
amarceau@chu-besancon.fr++33677132916

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026