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

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ClinicalTrials.gov Identifier: NCT03931148
Recruitment Status : Not yet recruiting
First Posted : April 30, 2019
Last Update Posted : April 30, 2019
Sponsor:
Collaborator:
Université de Montréal
Information provided by (Responsible Party):
Thomas TANNOU, Centre Hospitalier Universitaire de Besancon

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 high resolution EEG) to geriatric expertise, associated with the performance of a battery of neuropsychological tests in the evaluation of decision-making capacity.

Condition or disease Intervention/treatment Phase
Decision Making Dementia Aging Diagnostic Test: Geriatric Assesment with neuropsychological test more specific on decision making Diagnostic Test: Functional RMI Diagnostic Test: High Resolution EEG Not Applicable

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 EEG-HR and functional MRI as diagnostic tools as part of an overall gerontological evaluation.

The question that arises is therefore that of the development of diagnostic tools.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: Analyses of functional imaging results (MRI and 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.
Primary Purpose: Diagnostic
Official Title: Feasibility Study of the Interest of Functional Neuroimaging in Assessing Decision-making Capacity of Older People With Neurocognitive Disorders
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : March 2021

Arm Intervention/treatment
Experimental: Intervention

After first consultation for diagnosis of neurodegenerative disorder :

  • Geriatric Assessment with specific neuropsychologic tests of decision making
  • fRMI
  • EEG High Resolution
Diagnostic Test: Geriatric Assesment with neuropsychological test more specific on decision making
The following tests will be made : MoCA, FAB, TMT, Stroop-Victoria, JAT

Diagnostic Test: Functional RMI
With specific test of decision making (IGT) specially adapted to the population

Diagnostic Test: High Resolution EEG
With specific test of decision making (BART) specially adapted to the population




Primary Outcome Measures :
  1. 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 [ Time Frame: 1 day ]

    Concerning functional neuroimaging: The lack of activation of brain areas will identify the patient as "doubtful of ability", while the activation of areas will identify the patient as "capable".

    Concerning standardized geriatric assessment: at the end of the consultation and more specific neuropsychological tests, the geriatrician will decide on his assessment of the patient's decision-making ability, classifying the patient as "fit" or "with neurocognitive disorders that render him incapable of making decisions".

    The hypothesis is that 10% of cases that are classified by clinical evaluation as "cognitively impaired impacting decision making" may have activation of the prefrontal ventromedial and dorsolateral cortex areas during neuroimaging (fMRI) evaluation, which would correspond to a potential improvement in diagnosis due to the use of imaging.



Secondary Outcome Measures :
  1. Comparison of % of patient with prefrontal cortical activation on EEG-HR with % of succeed on MoCA from the neuropsychological reference tests of geriatric assessment. [ Time Frame: 1 day ]
    To date, it is the combined neuropsychological tests in geriatric assessment that make it possible, through cumulative analysis coupled with structural imaging, to describe the functioning of some of the skills required for decision-making. The evaluation of each functional neuroimaging marker (EEG-HR and fRMI) should therefore be compared to each of the main reference elements: cognitive evaluation with MocA, executive function with FAB and Stroop and judgment with JAT.

  2. Comparison of % of patient with prefrontal cortical activation on fMRI with % of succeed on MoCA from the neuropsychological reference tests of geriatric assessment [ Time Frame: 1 day ]
    To date, it is the combined neuropsychological tests in geriatric assessment that make it possible, through cumulative analysis coupled with structural imaging, to describe the functioning of some of the skills required for decision-making. The evaluation of each functional neuroimaging marker (EEG-HR and fRMI) should therefore be compared to each of the main reference elements: cognitive evaluation with MocA, executive function with FAB and Stroop and judgment with JAT.

  3. Comparison of % of patient with prefrontal cortical activation on EEG-HR with % of succeed on FAB from the neuropsychological reference tests of geriatric assessment [ Time Frame: 1 day ]
    To date, it is the combined neuropsychological tests in geriatric assessment that make it possible, through cumulative analysis coupled with structural imaging, to describe the functioning of some of the skills required for decision-making. The evaluation of each functional neuroimaging marker (EEG-HR and fRMI) should therefore be compared to each of the main reference elements: cognitive evaluation with MocA, executive function with FAB and Stroop and judgment with JAT.

  4. Comparison of % of patient with prefrontal cortical activation on fRMI with % of succeed on FAB from the neuropsychological reference tests of geriatric assessment [ Time Frame: 1 day ]
    To date, it is the combined neuropsychological tests in geriatric assessment that make it possible, through cumulative analysis coupled with structural imaging, to describe the functioning of some of the skills required for decision-making. The evaluation of each functional neuroimaging marker (EEG-HR and fRMI) should therefore be compared to each of the main reference elements: cognitive evaluation with MocA, executive function with FAB and Stroop and judgment with JAT.

  5. Comparison of % of patient with prefrontal cortical activation on fRMI with % of succeed on JAT from the neuropsychological reference tests of geriatric assessment [ Time Frame: 1 day ]
    To date, it is the combined neuropsychological tests in geriatric assessment that make it possible, through cumulative analysis coupled with structural imaging, to describe the functioning of some of the skills required for decision-making. The evaluation of each functional neuroimaging marker (EEG-HR and fRMI) should therefore be compared to each of the main reference elements: cognitive evaluation with MocA, executive function with FAB and Stroop and judgment with JAT.

  6. Comparison of % of patient with prefrontal cortical activation on EEG-HR with % of succeed on JAT from the neuropsychological reference tests of geriatric assessment [ Time Frame: 1 day ]
    To date, it is the combined neuropsychological tests in geriatric assessment that make it possible, through cumulative analysis coupled with structural imaging, to describe the functioning of some of the skills required for decision-making. The evaluation of each functional neuroimaging marker (EEG-HR and fRMI) should therefore be compared to each of the main reference elements: cognitive evaluation with MocA, executive function with FAB and Stroop and judgment with JAT.

  7. Comparison of % of patient with prefrontal cortical activation on EEG-HR with % of succeed on Stroop-Victoria from the neuropsychological reference tests of geriatric assessment [ Time Frame: 1 day ]
    To date, it is the combined neuropsychological tests in geriatric assessment that make it possible, through cumulative analysis coupled with structural imaging, to describe the functioning of some of the skills required for decision-making. The evaluation of each functional neuroimaging marker (EEG-HR and fRMI) should therefore be compared to each of the main reference elements: cognitive evaluation with MocA, executive function with FAB and Stroop and judgment with JAT.

  8. Comparison of % of patient with prefrontal cortical activation on fRMI with % of succeed on Stroop-Victoria from the neuropsychological reference tests of geriatric assessment [ Time Frame: 1 day ]
    To date, it is the combined neuropsychological tests in geriatric assessment that make it possible, through cumulative analysis coupled with structural imaging, to describe the functioning of some of the skills required for decision-making. The evaluation of each functional neuroimaging marker (EEG-HR and fRMI) should therefore be compared to each of the main reference elements: cognitive evaluation with MocA, executive function with FAB and Stroop and judgment with JAT.



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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Delirium
  • Major depressive symptoms
  • MRI contraindication

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03931148


Contacts
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Contact: Thomas TANNOU, MD +33381669003 ttannou@chu-besancon.fr
Contact: Aurelie MARCEAU, PhD ++33677132916 amarceau@chu-besancon.fr

Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
Université de Montréal
Investigators
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Study Chair: Regis AUBRY, PhD Centre Hospitalier Universitaire de Besancon
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Responsible Party: Thomas TANNOU, University Hospital Practitioner, Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT03931148    
Other Study ID Numbers: IMAGISION
API3A2018 ( Other Grant/Funding Number: CHU de Besancon )
Don Du Souffle 2018 ( Other Grant/Funding Number: Don du Souffle Besancon )
First Posted: April 30, 2019    Key Record Dates
Last Update Posted: April 30, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Thomas TANNOU, Centre Hospitalier Universitaire de Besancon:
Neuroimaging
Dementia
Decision making
Neuropsychology
Aging
Additional relevant MeSH terms:
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Dementia
Neurocognitive Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Mental Disorders