跳至主要内容
临床试验/NCT06262529
NCT06262529招募中不适用

Trajectories of Neurocognitive Impairment After Ischemic Stroke in Young Subjects

Centre Hospitalier Universitaire de Nice4 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2024年2月8日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
16
试验地点
4
主要终点
evolution of neurocognitive disorders (trajectories of global cognitive efficiency) over 1 year after stroke

研究概览

简要总结

Affecting more than 150,000 patients in France, stroke is a major public health issue and a leading cause of disability worldwide. In western countries, 80-85% of strokes are of ischemic subtype. This study will focus on young adults, aged 18-45, with a diagnosis of ischemic stroke.

Studies assessing post-stroke cognition in young patients reported an alarming prevalence of cognitive impairment, affecting about 60% of stroke survivors between 4 and 12 months after the acute event. However, longitudinal data on neurocognitive trajectories (i.e., the evolution of cognitive impairment over time) in young patients with ischemic stroke are lacking. Collecting such data requires an exhaustive neuropsychological assessment and several functional evaluations, at different times, for the same patient.

Repeated neurocognitive study of young patients with ischemic stroke will enable: a description of the prevalence of impaired global cognitive efficiency, an analysis of the specific neurocognitive domains affected, and the tracing of trajectories of recovery from cognitive impairment over time, in terms of global cognitive efficiency and as a function of specific neurocognitive domains (memory, executive, attentional, social cognition, instrumental functions, fatigability, etc.).

Up to date, the clinic-radiological predictors and associated factors of neurocognitive impairment after ischemic stroke in young patients have not been studied. Ischemic stroke causes acute brain lesions of the gray matter (GM) and white matter (WM). Numerous studies suggest that cognitive health may be more closely linked to the integrity of WM than to GM. Magnetic resonance imaging (MRI), and in particular diffusion tensor imaging (DTI) sequences, analyze WM bundles. By using fiber tracking algorithms image analysis enable the WM fiber bundle reconstruction and allow quantifying the volume of lesions (pre-existing and ischemic stroke-induced) in the WM tract.

The aim of this study is to study whether the extension of pre-existing and acute white matter lesions is associated with poorer cognitive recovery after ischemic stroke, both in terms of global cognitive performance and impairment in specific neurocognitive domains.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age: 18 to 45 years.
  • Pathology: ischemic stroke diagnosed with brain MRI as per standard clinical practice, with or without occlusion of proximal artery, anterior or posterior circulation.
  • Ability to understand and complete study tests and questionnaires: fluent French speaker and reader.
  • All patients must be affiliated to a social security scheme.
  • Signature of informed consent form.

排除标准

  • Pre-existing cognitive impairment (defined as CQI <78 or clinical dementia).
  • Severe functional dependence prior to stroke (defined as Modified Rankin Scale MRS = score 5).
  • Any neurological or psychiatric comorbidity.
  • Sensory disorders: visual impairment, blindness, deafness.
  • Severe acquired phasic disorders: on the expressive oral side, in the presence of an inability to express oneself, which interferes with the collection of responses to neuropsychological tests; and on the receptive oral side, in the presence of an inability to understand the instructions of neuropsychological tests. Phasic functioning is systematically assessed during hospitalization by means of the NIHSS (score ≤ 2 on the "Language" sub-test), and will be rechecked clinically and psychometrically during neuropsychological assessments using the Language Screening Test (LAST) for both expression and oral comprehension. - Severe motor disorders: inability to mobilize the dominant upper limb for written neuropsychological tests.
  • Contraindication to MRI.
  • Pregnant women.
  • HIV-positive patients: interaction of infectious pathology on cognitive functioning. Declarative, no HIV tests will be performed.
  • Withdrawal of informed consent.
  • Consumption of alcohol and/or narcotics on the day of neuropsychological assessments.

结局指标

主要结局

evolution of neurocognitive disorders (trajectories of global cognitive efficiency) over 1 year after stroke

时间窗: Between 3 months and 12 months

Montréal cognitive assessment (MOCA - score 0 to 30)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

Loading locations...

相似试验