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

Aging Clinical Trial

— IMAGISION  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03931148
• Other study ID #: API/2018/100
• Secondary ID: API3A2018Don Du
• Status: Recruiting
• Phase: N/A
• Start date: January 5, 2020
• Est. completion date: April 2023

Study information

• Verified date: August 2021
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: Thomas TANNOU, MD
• Phone: +33381669003
• Email: ttannou[@]chu-besancon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 74
• Est. completion date: April 2023
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

Inclusion Criteria:

• French speaker

• Recent diagnosis of neurocognitive disorder

• Agreed with the study

Exclusion Criteria:

• Delirium

• Major depressive symptoms

• MRI contraindication

Related Conditions & MeSH terms

• Aging
• Decision Making
• Dementia
• Neurocognitive Disorders

Intervention

Diagnostic Test:
• Geriatric Assesment with neuropsychological test more specific on decision making
The following tests will be made : MoCA, FAB, TMT, Stroop-Victoria, JAT
• Functional RMI
With specific test of decision making (IGT) specially adapted to the population
• High Resolution EEG
With specific test of decision making (BART) specially adapted to the population

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

Locations

Country	Name	City	State
Canada	CRIUGM	Montreal	Quebec
France	Centre Hospitalier Universitaire de Besancon	Besancon	BFC

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon	Université de Montréal

Countries where clinical trial is conducted

Canada,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	1 day
Other	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	1 day
Other	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.	1 day
Primary	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 ".	1