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

C

Centre Hospitalier Universitaire de Besancon

Status

Unknown

Conditions

Aging
Decision Making
Dementia

Treatments

Diagnostic Test: Geriatric Assesment with neuropsychological test more specific on decision making
Diagnostic Test: Functional RMI
Other: Qualitative interview
Diagnostic Test: High Resolution EEG

Study type

Interventional

Funder types

Other

Identifiers

NCT03931148
API/2018/100
API3A2018 (Other Grant/Funding Number)
Prix H Mutuelle Alzheimer 2019 (Other Grant/Funding Number)
Don Du Souffle 2018 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

74 estimated patients

Sex

All

Ages

70+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • Delirium
  • Major depressive symptoms
  • MRI contraindication

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

74 participants in 1 patient group

Intervention
Experimental group
Description:
After first consultation for diagnosis of neurodegenerative disorder : * Geriatric Assessment with specific neuropsychologic tests of decision making * fRMI * EEG High Resolution * Qualitative interview
Treatment:
Diagnostic Test: Functional RMI
Diagnostic Test: High Resolution EEG
Diagnostic Test: Geriatric Assesment with neuropsychological test more specific on decision making
Other: Qualitative interview

Trial contacts and locations

2

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Central trial contact

Aurelie MARCEAU, PhD; Thomas TANNOU, MD

Data sourced from clinicaltrials.gov

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