Cerebellar Stroke and Mood Disorders
- Conditions
- Stroke
- Interventions
- Other: Post stroke mood disorders evaluation
- Registration Number
- NCT03515486
- Lead Sponsor
- University Hospital, Bordeaux
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 38
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Post-stroke mood disorders evaluation Post stroke mood disorders evaluation 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.
- Primary Outcome Measures
Name Time Method Apathy Inventory (AI) Day 0 Apathetic syndrome defined by a score \> 2 on AI.
Center of Epidemiological Studies-Depression scale (CES-D) 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) Day 0 Evaluation of anxiety disorder defined by a score\> 22 on the BAI scale
- Secondary Outcome Measures
Name Time Method Actimetry During 7 days Circadian rhythms : sleep fragmentation and relative amplitude of circadian rhythms measured using one-week actimetry.
Experience Sampling Method (ESM) evaluations During 7 days Evaluation of daily-life mood disorders using one-week Experience Sampling Method (ESM) evaluations (smartphone)
Interpersonal Reactivity Index (IRI) 24 to 48 months Evaluation of emotional dysregulation
Facial emotion recognition tests 24 to 48 months Evaluation of emotional dysregulation
Brain Magnetic Resonance Imaging Day 0 Indexes of the structural and functional integrity of emotional regulation networks
Trait-Meta-Mood-Scale (TMMS) 24 to 48 months Evaluation of emotional dysregulation
Center of Epidemiological Studies-Depression scale (CES-D) 24 to 48 months Evaluation of depressive syndrome defined by a score\> 17 for men and\> 23 for women according to the CES-D
Beck Anxiety Inventory (BAI) 24 to 48 months Evaluation of anxiety disorder defined by a score\> 22 on the BAI scale
Apathy Inventory (AI) 24 to 48 months Apathetic syndrome defined by a score \> 2 on AI.
Trial Locations
- Locations (1)
CHU de Bordeaux
🇫🇷Bordeaux, France