Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID07295652

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

Led by Centre Hospitalier St Anne · Updated on 2025-12-19

600

Participants Needed

3

Research Sites

N/A

Total Duration

On this page

Sponsors

C

Centre Hospitalier St Anne

Lead Sponsor

I

Institut du Cerveau et de la Moelle (ICM Institute)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating high-level cognitive impairments that occur across a broad range of severe neuropsychiatric and neurological disorders, including schizophrenia, mood disorders, autism spectrum disorders, obsessive-compulsive disorder, neurodegenerative diseases, focal neurological lesions, and epilepsy. This study aims to create a comprehensive atlas that identifies both shared and disorder-specific cognitive deficits by comparing patients' cognitive performance to that of healthy volunteers. The study also plans to track changes in cognitive function over time and in relation to treatment or symptom changes, while exploring underlying brain mechanisms linked to these impairments. Participants will undergo computerized neuropsychological assessments covering various cognitive domains such as motivation, metacognition, conscious awareness, and causal inference. These tests will be adapted progressively to become shorter, more user-friendly, and digital-device compatible, based on participant feedback and interim results. Additional optional assessments include brain imaging techniques such as MRI without contrast, electroencephalography (EEG), and magnetoencephalography (MEG) to explore neural correlates of cognitive deficits. The study is prospective and multicenter, involving both patients and healthy volunteers. During the study, participants will complete repeated cognitive tests at baseline and follow-up visits up to one year later to measure changes and optimize testing. Imaging assessments may occur between baseline and study completion and can extend up to 10 years for patients under clinical follow-up. Researchers will monitor cognitive performance scores and relate them to clinical changes and therapeutic interventions. The primary outcome is performance on validated computerized cognitive tasks, while secondary outcomes include imaging results and predictive capacity for differential diagnosis. This minimal-risk study supports creating a detailed database of cognitive dysfunctions across neuropsychiatric disorders.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • For healthy volunteers: Current diagnosis of a psychiatric disorder according to ICD-10 (F20-F98) or current prescription of 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 such as stroke, coma, epilepsy, neuroinflammatory or neurodegenerative disease, or identified cognitive disorder
  • Inability to complete cognitive testing due to motor or sensory impairment
  • For participants undergoing MRI: Presence of MRI contraindications such as non-MRI-compatible pacemaker, heart valve, implant, or metallic foreign body
  • Pregnancy at the time of MRI

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - Baseline and repeated evaluations up to one year after baseline

Participants undergo computerized neuropsychological assessments designed to evaluate high-level cognitive impairments. These assessments cover various cognitive domains such as motivation, metacognition, conscious access, and Bayesian causal inference. Tests will be progressively optimized for usability and adapted to participants' specific difficulties.

Repeated visits scheduled in relation to clinical evolution and therapeutic interventions

Diagnostic Evaluation

Duration - Single visit for each optional imaging assessment

Optional brain imaging assessments including MRI without contrast, EEG, and MEG are performed to identify neural correlates of cognitive deficits. These evaluations may be offered once during the study.

1 visit (in-person) per imaging modality if performed

Long-term Monitoring

Duration - Up to 10 years for patients; up to 1 year for healthy volunteers

Participants are monitored through repeated cognitive evaluations and optional brain imaging over an extended period to observe the evolution of cognitive impairments and clinical changes, supporting research up to 10 years for patients and up to 1 year for healthy volunteers.

Visits depend on clinical follow-up and study schedule

Trial Site Locations

Total: 3 locations

1

Departement of Adult Psychiatry, GH Pitié Salpétrière

Paris, France, 75013

Actively Recruiting

2

Groupe hospitalo-universitaire Paris Psychiatrie et Neurosciences

Paris, France, 75014

Actively Recruiting

3

Hôpital Fondation Adolphe de Rothschild

Paris, France

Not Yet Recruiting

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Research Team

J

Jacob DHOTE, Dr

F

Fabien VINCKIER, Pr

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

1

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