Interest of Functional Neuroimaging in Assessing Decision-making Capacity of Older People With Neurocognitive Disorders (IMAGISION)
Primary Purpose
Decision Making, Dementia, Aging
Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Geriatric Assesment with neuropsychological test more specific on decision making
Functional RMI
High Resolution EEG
Qualitative interview
Sponsored by
About this trial
This is an interventional diagnostic trial for Decision Making focused on measuring Neuroimaging, Dementia, Decision making, Neuropsychology, Aging
Eligibility Criteria
Inclusion Criteria:
- French speaker
- Recent diagnosis of neurocognitive disorder
- Agreed with the study
Exclusion Criteria:
- Delirium
- Major depressive symptoms
- MRI contraindication
Sites / Locations
- CRIUGMRecruiting
- Centre Hospitalier Universitaire de BesanconRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention
Arm Description
After first consultation for diagnosis of neurodegenerative disorder : Geriatric Assessment with specific neuropsychologic tests of decision making fRMI EEG High Resolution Qualitative interview
Outcomes
Primary Outcome Measures
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 ".
Secondary Outcome Measures
Full Information
NCT ID
NCT03931148
First Posted
April 23, 2019
Last Updated
August 17, 2021
Sponsor
Centre Hospitalier Universitaire de Besancon
Collaborators
Université de Montréal
1. Study Identification
Unique Protocol Identification Number
NCT03931148
Brief Title
Interest of Functional Neuroimaging in Assessing Decision-making Capacity of Older People With Neurocognitive Disorders
Acronym
IMAGISION
Official Title
Feasibility Study of the Interest of Functional Neuroimaging in Assessing Decision-making Capacity of Older People With Neurocognitive Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 5, 2020 (Actual)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
April 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon
Collaborators
Université de Montréal
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Decision Making, Dementia, Aging
Keywords
Neuroimaging, Dementia, Decision making, Neuropsychology, Aging
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
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.
Allocation
N/A
Enrollment
74 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
After first consultation for diagnosis of neurodegenerative disorder :
Geriatric Assessment with specific neuropsychologic tests of decision making
fRMI
EEG High Resolution
Qualitative interview
Intervention Type
Diagnostic Test
Intervention Name(s)
Geriatric Assesment with neuropsychological test more specific on decision making
Intervention Description
The following tests will be made : MoCA, FAB, TMT, Stroop-Victoria, JAT
Intervention Type
Diagnostic Test
Intervention Name(s)
Functional RMI
Intervention Description
With specific test of decision making (IGT) specially adapted to the population
Intervention Type
Diagnostic Test
Intervention Name(s)
High Resolution EEG
Intervention Description
With specific test of decision making (BART) specially adapted to the population
Intervention Type
Other
Intervention Name(s)
Qualitative interview
Intervention Description
Qualitative semi-directed interviews with participants, their caregivers and their geriatrician to analyse everyday life decision making ability.
Primary Outcome Measure Information:
Title
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
Description
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
Other Pre-specified Outcome Measures:
Title
Comparison between neuropsychological test and neurofunctional imaging
Description
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
Title
Comparison between neurocognitive disorders stage and decision-making ability
Description
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
Title
Analysis of the implication of the decision-making ability in everyday life situation
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
French speaker
Recent diagnosis of neurocognitive disorder
Agreed with the study
Exclusion Criteria:
Delirium
Major depressive symptoms
MRI contraindication
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas TANNOU, MD
Phone
+33381669003
Email
ttannou@chu-besancon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Aurelie MARCEAU, PhD
Phone
++33677132916
Email
amarceau@chu-besancon.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Regis AUBRY, PhD
Organizational Affiliation
Centre Hospitalier Universitaire de Besancon
Official's Role
Study Chair
Facility Information:
Facility Name
CRIUGM
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3W1W6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas TANNOU, MD
Phone
+15143403540
Email
thomas.tannou@umontreal.ca
First Name & Middle Initial & Last Name & Degree
Sven JOUBERT, PhD
Phone
+15143403540
Email
sven.joubert@umontreal.ca
First Name & Middle Initial & Last Name & Degree
Sven JOUBERT, PhD
Facility Name
Centre Hospitalier Universitaire de Besancon
City
Besancon
State/Province
BFC
ZIP/Postal Code
25000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas TANNOU, MD
Phone
+33381669003
First Name & Middle Initial & Last Name & Degree
Thomas TANNOU, MD
First Name & Middle Initial & Last Name & Degree
Eloi MAGNIN, MD-PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34588264
Citation
Tannou T, Godard-Marceau A, Joubert S, Daneault S, Kergoat MJ, Magnin E, Comte A, Gabriel D, Vidal C, Pazart L, Aubry R. Added value of functional neuroimaging to assess decision-making capacity of older adults with neurocognitive disorders: protocol for a prospective, monocentric, single-arm study (IMAGISION). BMJ Open. 2021 Sep 29;11(9):e053549. doi: 10.1136/bmjopen-2021-053549.
Results Reference
derived
Learn more about this trial
Interest of Functional Neuroimaging in Assessing Decision-making Capacity of Older People With Neurocognitive Disorders
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