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Neurologic DisordersCOGPSYNCT07295652

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

A study testing Cognitive assessment, Brain MRI (optional) and Electroencephalography (optional) in people with Neurologic Disorders and Schizophrenia, run by Centre Hospitalier St Anne at 3 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Cognitive assessment, Brain MRI (optional) and Electroencephalography (optional)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
600 participants
Where
3 sitesFrance
Study dates
12 Mar 2024to Mar 2039
Phase
Interventional
Are there results?
Not yet: the study is under way

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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 9Show fewer
  • Aged over 18 years
  • Provided written informed consent
  • Affiliated with a social security scheme

Who cannot join

  • 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)
Show all 9Show fewer
  • 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

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jacob DHOTE, Dr contact

+33 145658177

j.dhote@ghu-paris.fr

Fabien VINCKIER, Pr contact

F.VINCKIER@ghu-paris.fr

France3 sites, 3 recruiting
  • Departement of Adult Psychiatry, GH Pitié Salpétrière

    Paris, 75013

    Philippe FOSSATI, Pr, 0142162870 ext. +33, philippe.fossati@aphp.fr

    Recruiting
  • Groupe hospitalo-universitaire Paris Psychiatrie et Neurosciences

    Paris, 75014

    Jacob DHOTE, Dr, 33 + 0145658177, j.dhote@ghu-paris.fr

    Fabien VINCKIER, Pr, F.VINCKIER@ghu-paris.fr

    Recruiting
  • Hôpital Fondation Adolphe de Rothschild

    Paris

    Pierre BOURDILLON, Dr

    Not yet recruiting

Other trials in France

About this study

Official title: Characterization of High-level Cognitive Impairments in Patients With Neuropsychiatric Disorders

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.

Read more

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.

Read the detailed description

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.

Being tested
Cognitive assessment, Brain MRI (optional), Electroencephalography (optional), Magnetoencephalography (optional)
Keywords
Cognitive dysfunction, Executive function, Metacognition, Motivation, Social cognition, Transdiagnostic approach, High-level cognition, Longitudinal cognitive changes, Cognitive profiling, Differential diagnosis
Medical subject headings
Nervous System Diseases, Schizophrenia, Bipolar Disorder, Depressive Disorder, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive assessmentBehavioural

    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)Behavioural

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

  • Electroencephalography (optional)Behavioural

    Electroencephalography performed at one visit

  • Magnetoencephalography (optional)Behavioural

    Magnetoencephalography performed at one visit

Study groups in NCT07295652
Study groupRoleWhat they receive
Cognitive assessmentExperimentalNeuropsychological assessment assessing different cognitive dimensions (e.g., motivation and decision-making, metacognition, access to consciousness, Bayesian inference)
Receives: Behavioral: Cognitive assessment; Behavioral: Brain MRI (optional); Behavioral: Electroencephalography (optional); Behavioral: Magnetoencephalography (optional)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, and up to one year after baseline

Secondary outcomes (8)
  1. 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.

    Measured: Baseline, and up to one year after baseline

  2. 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

    Measured: Baseline, and up to one year after baseline

  3. 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.

    Measured: At MRI visit, between baseline and study completion (up to 10 years for patients; up to 1 year for healthy volunteers)

  4. 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.

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

  5. 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.

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

  6. 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.

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

  7. 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.

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

  8. 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.

    Measured: Baseline, and up to one year after baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2025
  2. Study start12 Mar 2024
  3. Primary completionMar 2039 (estimated)
  4. Study completionMar 2039 (estimated)

Resources

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
Basic science
Allocation
Not applicable
Intervention model
Single group
Model description
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
Masking
None (open label)
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07295652
Sponsor's protocol ID
D22-P009
Acronym
COGPSY
Status last verified
Dec 2025
First submitted
13 Jun 2025
Last updated
19 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive assessment, Brain MRI (optional) and Electroencephalography (optional) in people with Neurologic Disorders and Schizophrenia, run by Centre Hospitalier St Anne at 3 sites in France.

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 9 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jacob DHOTE, Dr (+33 145658177, j.dhote@ghu-paris.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Performance scores on validated computerized neuropsychological tasks assessing high-level cognitive domains (time frame: Baseline, and up to one year after baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 19 Dec 2025.

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