Characterization of High-level Cognitive Impairments in Patients With Neuropsychiatric Disorders
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 5
- 主要终点
- Performance scores on validated computerized neuropsychological tasks assessing high-level cognitive domains
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Performance scores on validated computerized neuropsychological tasks assessing high-level cognitive domains
时间窗: Baseline, and up to one year after baseline
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.
次要结局
- 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))
- Magnetoencephalography (MEG) event-related potentials (ERP) during cognitive tasks(At MEG visits, from baseline through study completion (up to 10 years for patients; up to 1 year for healthy volunteers))
- MEG time-frequency analyses during cognitive tasks(At MEG visits, from baseline through study completion (up to 10 years for patients; up to 1 year for healthy volunteers))
- Predictive capacity of cognitive performance scores for differential diagnosis(Baseline, and up to one year after baseline)