Characterization of High-Level Cognitive Impairments in Patients With Neuropsychiatric Disorders

NCT07295652 | Recruiting

• 1 other identifier: D22-P009
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Neurologic Disorders; Schizophrenia; Bipolar Disorder (BD); Depressive Disorder

Keywords

Cognitive dysfunction; Executive function; Metacognition; Motivation; Social cognition; Transdiagnostic approach; High-level cognition; Longitudinal cognitive changes; Cognitive profiling; Differential diagnosis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• Optimization of performance scores on validated computerized neuropsychological tasks

  Baseline, and up to one year after baseline

• Change from baseline in performance scores on validated computerized neuropsychological tasks

  Baseline, and up to one year after baseline

• Structural and functional MRI

  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

  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

  At EEG visits, from baseline through study completion (up to 10 years for patients; up to 1 year for healthy volunteers)

Study Arms (1)

Cognitive assessment

EXPERIMENTAL

Neuropsychological assessment assessing different cognitive dimensions (e.g., motivation and decision-making, metacognition, access to consciousness, Bayesian inference)

Behavioral: Cognitive assessment; Behavioral: Brain MRI (optional); Behavioral: Electroencephalography (optional); Behavioral: Magnetoencephalography (optional)

Interventions

Brain MRI (optional) BEHAVIORAL

Brain MRI without contrast perform at one visit to identify neural correlates of cognitive deficits

Cognitive assessment

Electroencephalography (optional) BEHAVIORAL

Electroencephalography performed at one visit

Cognitive assessment

Magnetoencephalography (optional) BEHAVIORAL

Magnetoencephalography performed at one visit

Cognitive assessment

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.

Cognitive assessment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For patients:
• Aged over 18 years
• Diagnosed with a psychiatric disorder according to ICD-10 by a psychiatrist (F10-F98) or diagnosed with a neurological disorder according to ICD-10 by a neurologist (G00-G99)
• Provided written informed consent
• Affiliated with a social security scheme
• For healthy volunteers:
• Aged over 18 years
• Provided written informed consent
• Affiliated with a social security scheme

You may not qualify if:

• For healthy volunteers:
• Current diagnosis of a psychiatric disorder according to ICD-10 (F20-F98) or current prescription of a psychotropic medication, or diagnosis of a neurological disorder according to ICD-10 (G00-G99)
• History of depression (F32)
• Substance use disorder (excluding tobacco)
• Neurological history (e.g., stroke, coma, epilepsy, neuroinflammatory or neurodegenerative disease) or identified cognitive disorder
• Inability to complete cognitive testing (e.g., due to motor or sensory impairment)
• For participants undergoing MRI (without contrast agent):
• Presence of MRI contraindications: non-MRI-compatible pacemaker, heart valve, implant, or metallic foreign body
• Pregnancy at the time of MRI

Sponsors & Collaborators

• Centre Hospitalier St Anne: lead
• Institut du Cerveau et de la Moelle (ICM Institute): collaborator

Study Sites (3)

Departement of Adult Psychiatry, GH Pitié Salpétrière

Paris, 75013, France

RECRUITING

Groupe hospitalo-universitaire Paris Psychiatrie et Neurosciences

Paris, 75014, France

RECRUITING

Hôpital Fondation Adolphe de Rothschild

Paris, France

NOT YET RECRUITING

MeSH Terms

Conditions

Nervous System Diseases; Schizophrenia; Bipolar Disorder; Depressive Disorder; Cognitive Dysfunction

Interventions

Mental Status and Dementia Tests; Magnetoencephalography

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Bipolar and Related Disorders; Mood Disorders; Cognition Disorders; Neurocognitive Disorders

Intervention Hierarchy (Ancestors)

Neuropsychological Tests; Psychological Tests; Behavioral Disciplines and Activities; Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Magnetometry; Investigative Techniques

Study Officials

• Pierre BOURDILLON, Dr

  Hôpital Fondation Adolphe de Rothschild

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacob DHOTE, Dr

CONTACT

+33 145658177; j.dhote@ghu-paris.fr

Fabien VINCKIER, Pr

CONTACT

F.VINCKIER@ghu-paris.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: June 13, 2025
• First Posted: December 19, 2025
• Study Start: March 12, 2024
• Primary Completion (Estimated): March 1, 2039
• Study Completion (Estimated): March 1, 2039
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 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.
• Access Criteria: 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.

Locations

FR (3)