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临床试验/NCT03515486
NCT03515486已完成不适用

Cerebellar Stroke and Mood Disorders

University Hospital, Bordeaux2 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2017年1月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
38
试验地点
2
主要终点
Apathy Inventory (AI)

研究概览

简要总结

Post-stroke mood disorders (PSMD), including depression, anxiety and apathy, are observed in about 30 % of stroke patients at follow-up 3 or 4 months after stroke occurrence. They impair the functional outcome of the patients and their quality of life. Among the different brain structures involved in PSMD the role of the cerebellum has been under-evaluated while it is now well-known to be involved in mood regulation. The aim of this study will be to describe the characteristics of early and late mood disorders following a first acute ischemic cerebellar stroke using face to face interviews and mobile technologies and investigate their pathophysiological mechanisms through advanced brain Magnetic resonance imaging (MRI) evaluation of cortico-cerebello-cortical morphological and functional connectivity.

详细描述

Stroke is the leading cause of acquired disability in adults. Beyond these physical consequences, stroke is a major cause of mood disorders (depression, anxiety, apathy), affecting more than 30% of patients at 3 months after the initial accident. These mood disorders impair patient's quality of life and their post-stroke functional recovery. Their detection is usually based on an interview conducted during a follow-up visit and intensity is measured through dedicated scales. However the sensitivity of these assessments could be improved by multiple daily ecological assessments carried out in the patient environment through mobile technologies such as smartphones (Experience Sampling Method) and actimeters. Moreover, a better understanding of the pathophysiological mechanisms underlying the presence of post-stroke mood disorders could improve their management. Clinical factors such as the severity of the disability or the female gender are associated with the occurrence of mood disorders but the independent role of the anatomical location of brain injury remains uncertain. During the last decade many studies have suggested the role of the cerebellum in the regulation of cognition and, to a lesser extent, mood. An anatomical or functional impairment of the cortico-cerebellar-cortical loops might contribute to the occurrence of the mood disorders observed in some patients with cerebellar lesion.

The aim of this project is to explore in the context of a cerebellar infarct the transverse association between the presence of post-stroke mood disorders, detected both by standard evaluations and assessments conducted in the ecological environment, and the functional and structural alteration of cortico-cerebellar-cortical loops evaluated by MRI.

研究设计

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

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with a first ischemic stroke affecting the cerebellum and returning to a post-visit AVS at 4 ± 1 month
  • Age > 18 ans
  • Modified Rankin Scale pre-stroke ≤ 1

排除标准

  • History of central neurological disorder
  • Pre-stroke cognitive impairment (IQ-code> 3.3) or post-stroke cognitive disorder defined by a MoCA < 24
  • History of mood disorders history in the 6 months prior stroke (clinical screening)
  • Moderate to severe leukoencephalopathy (Fazekas score ≥ 2 )
  • Unable to use a smartphone (aphasia, visual disorder…)
  • Participation in a pharmacological protocol involving psychotropic drugs (anxiolytics, antidepressants, antipsychotics) or a non-pharmacological protocol involving psychotherapeutic management
  • Pregnancy
  • MRI contra-indication(pacemaker, claustrophobia ...)
  • Non affiliated to the French social insurance

研究组 & 干预措施

Post-stroke mood disorders evaluation

Experimental

Each patient will be assessed by a clinical evaluation, will have a standardized psychological evaluation, will perform a brain MRI and will be given a smartphone and an actimeter for a one-week period for the purpose of ecological evaluations.

干预措施: Post stroke mood disorders evaluation (Other)

结局指标

主要结局

Apathy Inventory (AI)

时间窗: Day 0

Apathetic syndrome defined by a score \> 2 on AI.

Center of Epidemiological Studies-Depression scale (CES-D)

时间窗: Day 0

Evaluation of depressive syndrome defined by a score\> 17 for men and\> 23 for women according to the CES-D

Beck Anxiety Inventory (BAI)

时间窗: Day 0

Evaluation of anxiety disorder defined by a score\> 22 on the BAI scale

次要结局

  • Experience Sampling Method (ESM) evaluations(During 7 days)
  • Actimetry(During 7 days)
  • Interpersonal Reactivity Index (IRI)(24 to 48 months)
  • Facial emotion recognition tests(24 to 48 months)
  • Brain Magnetic Resonance Imaging(Day 0)
  • Trait-Meta-Mood-Scale (TMMS)(24 to 48 months)
  • Center of Epidemiological Studies-Depression scale (CES-D)(24 to 48 months)
  • Beck Anxiety Inventory (BAI)(24 to 48 months)
  • Apathy Inventory (AI)(24 to 48 months)

研究者

发起方
University Hospital, Bordeaux
申办方类型
Other
责任方
Sponsor

研究点 (2)

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