Decision MakingIMAGISIONNCT03931148
Interest of Functional Neuroimaging in Assessing Decision-making Capacity of Older People With Neurocognitive Disorders
A study testing Geriatric Assesment with neuropsychological test more specific on decision making, Functional RMI and High Resolution EEG in people with Decision Making and Dementia, run by Centre Hospitalier Universitaire de Besancon at 2 sites in 2 countries.
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… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Decision Making, Dementia, Aging
- What is being tested?
- Geriatric Assesment with neuropsychological test more specific on decision making, Functional RMI and High Resolution EEG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 5 Jan 2020to Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- French speaker
- Recent diagnosis of neurocognitive disorder
- Agreed with the study
Who cannot join
- Delirium
- Major depressive symptoms
- MRI contraindication
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Canada1 site, 1 recruiting
- Recruiting
CRIUGM
Montreal, Quebec, H3W1W6
Thomas TANNOU, MD, +15143403540, thomas.tannou@umontreal.ca
Sven JOUBERT, PhD, +15143403540, sven.joubert@umontreal.ca
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Universitaire de Besancon
Besançon, Bourgogne-Franche-Comté, 25000
Thomas TANNOU, MD, +33381669003
Thomas TANNOU, MD
About this study
Official title: Feasibility Study of the Interest of Functional Neuroimaging in Assessing Decision-making Capacity of Older People With Neurocognitive Disorders
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.
Read the 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.
- Conditions
- Decision Making, Dementia, Aging
- Being tested
- Geriatric Assesment with neuropsychological test more specific on decision making, Functional RMI, High Resolution EEG, Qualitative interview
- Keywords
- Neuroimaging, Dementia, Decision making, Neuropsychology, Aging
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Geriatric Assesment with neuropsychological test more specific on decision makingDiagnostic test
The following tests will be made : MoCA, FAB, TMT, Stroop-Victoria, JAT
Functional RMIDiagnostic test
With specific test of decision making (IGT) specially adapted to the population
High Resolution EEGDiagnostic test
With specific test of decision making (BART) specially adapted to the population
Qualitative interviewOther
Qualitative semi-directed interviews with participants, their caregivers and their geriatrician to analyse everyday life decision making ability.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | After first consultation for diagnosis of neurodegenerative disorder :
* Geriatric Assessment with specific neuropsychologic tests of decision making
* fRMI
* EEG High Resolution
* Qualitative interview Receives: Diagnostic Test: Geriatric Assesment with neuropsychological test more specific on decision making; Diagnostic Test: Functional RMI; Diagnostic Test: High Resolution EEG; Other: Qualitative interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 ".
Measured: 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2019
- Study start5 Jan 2020
- Primary completionSep 2022 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Decision MakingStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Collaborators
- Université de Montréal
- Responsible party
- Principal investigator, Thomas TANNOU, Centre Hospitalier Universitaire de Besancon
- Investigators
- Regis AUBRY, PhD, Study chair, Centre Hospitalier Universitaire de Besancon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03931148
- Sponsor's protocol ID
- API/2018/100
- Other IDs
- API3A2018, Don Du Souffle 2018, Prix H Mutuelle Alzheimer 2019
- Acronym
- IMAGISION
- Status last verified
- Aug 2021
- First submitted
- 23 Apr 2019
- Last updated
- 23 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34588264
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of the Interest of Functional Neuroimaging in Assessing Decision-making Capacity of Older People With Neurocognitive Disorders
- ClinicalTrials.gov ID
- NCT03931148
- Acronym / sponsor ID
- IMAGISION / API/2018/100
- Conditions
- Decision Making, Dementia, Aging
- Keywords
- Neuroimaging, Dementia, Decision making, Neuropsychology, Aging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Collaborators
- Université de Montréal
- Study start
- 5 Jan 2020 (actual)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 30 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Diagnostic Test: Geriatric Assesment with neuropsychological test more specific on decision making, Diagnostic Test: Functional RMI, Diagnostic Test: High Resolution EEG, Other: Qualitative interviewAfter first consultation for diagnosis of neurodegenerative disorder : * Geriatric Assessment with specific neuropsychologic tests of decision making * fRMI * EEG High Resolution * Qualitative interview |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- French speaker
- Recent diagnosis of neurocognitive disorder
- Agreed with the study
Key exclusion criteria (3 listed)
- Delirium
- Major depressive symptoms
- MRI contraindication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Geriatric Assesment with neuropsychological test more specific on decision makingThe following tests will be made : MoCA, FAB, TMT, Stroop-Victoria, JAT | Diagnostic test | Intervention |
| Functional RMIWith specific test of decision making (IGT) specially adapted to the population | Diagnostic test | Intervention |
| High Resolution EEGWith specific test of decision making (BART) specially adapted to the population | Diagnostic test | Intervention |
| Qualitative interviewQualitative semi-directed interviews with participants, their caregivers and their geriatrician to analyse everyday life decision making ability. | Other | Intervention |
Primary outcome
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
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 ".
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2021.
- Derived from this study: PubMed 34588264Tannou 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Regis AUBRY, PhD study chair
Centre Hospitalier Universitaire de Besancon
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Geriatric Assesment with neuropsychological test more specific on decision making, Functional RMI and High Resolution EEG in people with Decision Making and Dementia, run by Centre Hospitalier Universitaire de Besancon at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas TANNOU, MD (+33381669003, ttannou@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03931148, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2021.