Interest of Functional Neuroimaging in Assessing Decision-making Capacity of Older People With Neurocognitive Disorders
IMAGISION
Feasibility Study of the Interest of Functional Neuroimaging in Assessing Decision-making Capacity of Older People With Neurocognitive Disorders
4 other identifiers
interventional
74
2 countries
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2020
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 23, 2019
CompletedFirst Posted
Study publicly available on registry
April 30, 2019
CompletedStudy Start
First participant enrolled
January 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2023
CompletedAugust 23, 2021
August 1, 2021
2.7 years
April 23, 2019
August 17, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (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
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
Other Outcomes (3)
Comparison between neuropsychological test and neurofunctional imaging
1 day
Comparison between neurocognitive disorders stage and decision-making ability
1 day
Analysis of the implication of the decision-making ability in everyday life situation
1 day
Study Arms (1)
Intervention
EXPERIMENTALAfter first consultation for diagnosis of neurodegenerative disorder : * Geriatric Assessment with specific neuropsychologic tests of decision making * fRMI * EEG High Resolution * Qualitative interview
Interventions
The following tests will be made : MoCA, FAB, TMT, Stroop-Victoria, JAT
With specific test of decision making (IGT) specially adapted to the population
With specific test of decision making (BART) specially adapted to the population
Qualitative semi-directed interviews with participants, their caregivers and their geriatrician to analyse everyday life decision making ability.
Eligibility Criteria
You may qualify if:
- French speaker
- Recent diagnosis of neurocognitive disorder
- Agreed with the study
You may not qualify if:
- Delirium
- Major depressive symptoms
- MRI contraindication
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
CRIUGM
Montreal, Quebec, H3W1W6, Canada
Centre Hospitalier Universitaire de Besancon
Besançon, Bourgogne-Franche-Comté, 25000, France
Related Publications (1)
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.
PMID: 34588264DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Regis AUBRY, PhD
Centre Hospitalier Universitaire de Besancon
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Masking Details
- 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.
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- University Hospital Practitioner
Study Record Dates
First Submitted
April 23, 2019
First Posted
April 30, 2019
Study Start
January 5, 2020
Primary Completion
September 1, 2022
Study Completion
April 1, 2023
Last Updated
August 23, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will not share