Health TrialsbyHealthPanel

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

ConditionsNeurologic DisordersSchizophreniaBipolar Disorder (BD)Depressive Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier St Anne

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

  • 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

Treatment groups

600 Participants
are divided into 1 treatment group
Group A: Cognitive assessmentExperimental treatment 4 interventions

Trial outcomes

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.

Time frame
Baseline, and up to one year after baseline

Secondary outcomes

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.

Time frame
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

Time frame
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.

Time frame
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.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Hospitalier St Anne

Lead sponsor

Institut du Cerveau et de la Moelle (ICM Institute)

Collaborator

Source ClinicalTrials.gov
Apply now