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| Name | Class |
|---|---|
| Paris Brain Institute (ICM) | OTHER |
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Neuropsychiatric disorders are extremely common, severe, and disabling conditions. In the field of psychiatry, they notably include schizophrenia, mood disorders (depressive and bipolar disorders), autism spectrum or neurodevelopmental disorders, obsessive-compulsive disorder, eating disorders, and personality disorders. In the field of neurology, one can cite neurodegenerative diseases (such as Alzheimer's disease, but also frontotemporal dementia or Parkinson's disease, which often represent frequent and challenging differential diagnoses of psychiatric disorders), focal neurological lesions (notably strokes and tumors), or epilepsy.
Cognitive impairments are present in nearly all neuropsychiatric disorders and contribute significantly to disability.
While impairments in working memory and attention, executive functions, and social cognition have been relatively well studied, other cognitive domains remain largely unexplored in these populations. This is particularly the case for various aspects of motivation, metacognition, conscious access, or causal (Bayesian) inference.
Although these domains likely play an important role in prognosis, no consensus currently exists regarding the methods for evaluating these functions.
The main objective of this study is to define a multidimensional, transdiagnostic atlas of high-level cognitive impairments-both specific and shared-across severe psychiatric disorders (notably schizophrenia, depressive disorder, bipolar disorder, autism spectrum or neurodevelopmental disorders, and obsessive-compulsive disorder) and neurological disorders (notably neurodegenerative diseases, focal neurological lesions, and epilepsy), by comparing them to healthy volunteers.
The investigators also aim to investigate the progression of cognitive impairments over time, across different phases of illness (symptom stabilization or exacerbation) or therapeutic intervention, through longitudinal follow-up of patients being monitored within the recruiting center.
Finally, in a more exploratory manner, the investigators aim to investigate the neural correlates of the identified cognitive impairments.
This study aims to construct a multidimensional, transdiagnostic atlas of high-level cognitive alterations across a range of severe neuropsychiatric conditions. These include schizophrenia, depressive disorders, bipolar disorder, autism spectrum or neurodevelopmental disorders, and obsessive-compulsive disorder, as well as neurological disorders such as neurodegenerative diseases, focal neurological lesions, and epilepsy. Cognitive performance in these groups will be compared to that of healthy volunteers in order to identify both disorder-specific and shared impairments.
Beyond this primary aim, the study seeks to refine and optimize the cognitive assessment tools used. Tests will be progressively adapted to be more ergonomic, shorter, and better suited for populations with neuropsychiatric conditions. This includes enhancing their intuitiveness, informativeness, and adaptability for digital platforms (e.g., tablet or mobile), while maintaining prior validation and calibration in healthy populations. The adaptation process will be informed by participant feedback and interim analysis.
The study will also examine how cognitive impairments evolve over time and with clinical changes, in participants undergoing psychiatric or neurological follow-up. Repeated cognitive evaluations will be scheduled in relation to clinical evolution, particularly before and after therapeutic interventions used in standard care, such as pharmacological treatment, non-invasive neurostimulation, psychotherapy, or psychoeducation.
In addition, the neural correlates of cognitive impairments will be explored using existing clinical brain imaging when available. Participants without prior imaging may be invited to undergo MRI scans, potentially including additional sequences such as DTI or functional MRI, without contrast administration. Complementary assessments using EEG or MEG may also be conducted, employing classical analyses such as event-related potentials and time-frequency analysis.
In some cases, causal inferences may be drawn by linking specific brain lesions in neurological patients to observed cognitive impairments. Finally, the study will explore whether selected cognitive tests could assist in differential diagnosis between psychiatric and neurological conditions, particularly neurodegenerative disorders.
This is a prospective, multicenter interventional study involving both healthy individuals and patients. It is classified as a minimal-risk, low-burden study and is designed to support the development of a comprehensive, comparative database of high-level cognitive dysfunctions across severe neuropsychiatric disorders.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive assessment | Experimental | Neuropsychological assessment assessing different cognitive dimensions (e.g., motivation and decision-making, metacognition, access to consciousness, Bayesian inference) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive assessment | Behavioral | This intervention consists of computerized neuropsychological assessments designed to evaluate high-level cognitive impairments. The tests cover various cognitive dimensions including motivation, metacognition, conscious access, and Bayesian causal inference. These assessments are performed using computers or tablets, aiming to build a multidimensional cognitive atlas comparing patients with severe psychiatric and neurological conditions to healthy volunteers. The tests will be progressively optimized for usability and adapted to the specific difficulties faced by patients. For some participants, additional brain imaging (MRI without contrast, EEG, MEG) may be offered optionally to identify neural correlates of cognitive deficits. |
| Measure | Description | Time Frame |
|---|---|---|
| Performance scores on validated computerized neuropsychological tasks assessing high-level cognitive domains | Cognitive functions will be assessed using a battery of validated computerized neuropsychological tasks. The specific tasks will be selected and optimized for each target population, based on prior validation in healthy controls. Performance scores (e.g., accuracy, reaction time, decision-making indices) will be compared between patients with severe neuropsychiatric disorders and healthy volunteers. | Baseline, and up to one year after baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Optimization of performance scores on validated computerized neuropsychological tasks | A battery of validated computerized neuropsychological tasks will be progressively optimized based on participant feedback and interim analyses. The convergence of performance scores will be evaluated over multiple trials to refine the tests, ensuring suitability for populations with severe neuropsychiatric or neurological disorders. |
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Inclusion Criteria:
For patients:
For healthy volunteers:
Exclusion Criteria:
For healthy volunteers:
For participants undergoing MRI (without contrast agent):
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jacob DHOTE, Dr | Contact | +33 145658177 | j.dhote@ghu-paris.fr | |
| Fabien VINCKIER, Pr | Contact | F.VINCKIER@ghu-paris.fr |
| Name | Affiliation | Role |
|---|---|---|
| Pierre BOURDILLON, Dr | Hôpital Fondation Adolphe de Rothschild | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Departement of Adult Psychiatry, GH Pitié Salpétrière | Recruiting | Paris | 75013 | France |
The data obtained from medical visits (clinical informations, cognitive data, medical imaging, and EEG/MEG recordings) will be kept, coded and archived for a period of two years after the last publication of the research results or until the final research report is signed. These can be used later for collaborative research (academic and/or industrial partners) in the European Union (EU) and/or abroad exclusively for scientific purposes.
The data obtained from medical visits (clinical informations, cognitive data, medical imaging, and EEG/MEG recordings) will be kept, coded and archived for a period of two years after the last publication of the research results or until the final research report is signed.
The data can be used for collaborative research (academic and/or industrial partners) in the European Union (EU) and/or abroad exclusively for scientific purposes. Any party must contact the sponsor, who has full property of the data.
In case of requested transfer of the anonymized database resulting from this research abroad (outside the EU), the sponsor will request information regarding data storage and management, to make sure that the other party will be able to ensure a level of security equivalent to French or European Union law.
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This interventional study includes two distinct populations: patients with severe neuropsychiatric or neurological disorders, and healthy volunteers. All participants undergo the same cognitive assessments and evaluations. There is no randomization or allocation to different intervention arms; instead, all subjects receive the same intervention protocol for comparative purposes
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|
| Brain MRI (optional) | Behavioral | Brain MRI without contrast perform at one visit to identify neural correlates of cognitive deficits |
|
| Electroencephalography (optional) | Behavioral | Electroencephalography performed at one visit |
|
| Magnetoencephalography (optional) | Behavioral | Magnetoencephalography performed at one visit |
|
| Baseline, and up to one year after baseline |
| Change from baseline in performance scores on validated computerized neuropsychological tasks | Changes in cognitive performance scores over time among patients undergoing standard clinical care, including therapeutic interventions. Cognitive evaluations will be repeated before and after major clinical events or treatment changes to assess cognitive stability or improvement | Baseline, and up to one year after baseline |
| Structural and functional MRI | Structural and functional MRI will be used to generate brain maps measuring gray matter volume (VBM), connectivity (DTI), and regional activation (fMRI). These MRI markers will be related to cognitive performance scores obtained during cognitive testing. Participation in MRI assessments is optional. | At MRI visit, between baseline and study completion (up to 10 years for patients; up to 1 year for healthy volunteers) |
| Electroencephalography (EEG) event-related potentials (ERP) during cognitive tasks | EEG recordings will be performed during cognitive tasks. Event-related potentials (ERP) will be analyzed to investigate neurophysiological correlates of cognitive performance. These markers will be related to cognitive alterations in patients and compared across groups. Participation in EEG assessments is optional. | At EEG visits, from baseline through study completion (up to 10 years for patients; up to 1 year for healthy volunteers) |
| EEG time-frequency analyses during cognitive tasks | EEG recordings will be performed during cognitive tasks. Time-frequency analyses will be used to investigate neurophysiological correlates of cognitive performance. These markers will be related to cognitive alterations in patients and compared across groups. Participation in EEG assessments is optional. | At EEG visits, from baseline through study completion (up to 10 years for patients; up to 1 year for healthy volunteers) |
| Magnetoencephalography (MEG) event-related potentials (ERP) during cognitive tasks | MEG recordings will be performed during cognitive tasks. Event-related potentials (ERP) will be analyzed to investigate neurophysiological correlates of cognitive performance. These ERP markers will be related to cognitive alterations in patients and compared across groups. Participation in MEG assessments is optional. | At MEG visits, from baseline through study completion (up to 10 years for patients; up to 1 year for healthy volunteers) |
| MEG time-frequency analyses during cognitive tasks | MEG recordings will be performed during cognitive tasks. Time-frequency analyses will be used to investigate neurophysiological correlates of cognitive performance. These markers will be related to cognitive alterations in patients and compared across groups. Participation in MEG assessments is optional. | At MEG visits, from baseline through study completion (up to 10 years for patients; up to 1 year for healthy volunteers) |
| Predictive capacity of cognitive performance scores for differential diagnosis | Validated cognitive performance tests will be used to evaluate patients longitudinally. The evolution of scores over time will be analyzed to determine the ability of these tests to discriminate between common differential diagnoses, such as frontotemporal dementia and depression. This outcome reflects the predictive capacity of cognitive tests for the final clinical diagnosis. | Baseline, and up to one year after baseline |
| Groupe hospitalo-universitaire Paris Psychiatrie et Neurosciences | Recruiting | Paris | 75014 | France |
|
| Hôpital Fondation Adolphe de Rothschild | Not yet recruiting | Paris | France |
|
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D012559 | Schizophrenia |
| D001714 | Bipolar Disorder |
| D003866 | Depressive Disorder |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
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| ID | Term |
|---|---|
| D000073216 | Mental Status and Dementia Tests |
| D015225 | Magnetoencephalography |
| ID | Term |
|---|---|
| D009483 | Neuropsychological Tests |
| D011581 | Psychological Tests |
| D004191 | Behavioral Disciplines and Activities |
| D003943 | Diagnostic Techniques, Neurological |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004568 | Electrodiagnosis |
| D060306 | Magnetometry |
| D008919 | Investigative Techniques |
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