MedDataX Logo

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

NCT ID: NCT07295652

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-12

Study Completion Date

2039-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Neurologic Disorders Schizophrenia Bipolar Disorder (BD) Depressive Disorder

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

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
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cognitive assessment

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

Group Type EXPERIMENTAL

Cognitive assessment

Intervention Type 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.

Brain MRI (optional)

Intervention Type BEHAVIORAL

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

Electroencephalography (optional)

Intervention Type BEHAVIORAL

Electroencephalography performed at one visit

Magnetoencephalography (optional)

Intervention Type BEHAVIORAL

Magnetoencephalography performed at one visit

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cognitive assessment

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.

Intervention Type BEHAVIORAL

Brain MRI (optional)

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

Intervention Type BEHAVIORAL

Electroencephalography (optional)

Electroencephalography performed at one visit

Intervention Type BEHAVIORAL

Magnetoencephalography (optional)

Magnetoencephalography performed at one visit

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Institut du Cerveau et de la Moelle (ICM Institute)

UNKNOWN

Sponsor Role collaborator

Centre Hospitalier St Anne

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pierre BOURDILLON, Dr

Role: PRINCIPAL_INVESTIGATOR

Hôpital Fondation Adolphe de Rothschild

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Departement of Adult Psychiatry, GH Pitié Salpétrière

Paris, , France

Site Status RECRUITING

Groupe hospitalo-universitaire Paris Psychiatrie et Neurosciences

Paris, , France

Site Status RECRUITING

Hôpital Fondation Adolphe de Rothschild

Paris, , France

Site Status NOT_YET_RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Jacob DHOTE, Dr

Role: CONTACT

Phone: +33 145658177

Email: [email protected]

Fabien VINCKIER, Pr

Role: CONTACT

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Philippe FOSSATI, Pr

Role: primary

Jacob DHOTE, Dr

Role: primary

Fabien VINCKIER, Pr

Role: backup

Pierre BOURDILLON, Dr

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

D22-P009

Identifier Type: -

Identifier Source: org_study_id