Cerebellar Stroke and Mood Disorders (CERMOOD)
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|ClinicalTrials.gov Identifier: NCT03515486|
Recruitment Status : Recruiting
First Posted : May 3, 2018
Last Update Posted : May 3, 2018
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Other: Post stroke mood disorders evaluation||Not Applicable|
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 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Cerebellar Stroke and Mood Disorders|
|Actual Study Start Date :||January 16, 2017|
|Estimated Primary Completion Date :||December 16, 2018|
|Estimated Study Completion Date :||December 16, 2018|
Experimental: 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.
Other: 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
- Center of Epidemiological Studies-Depression scale (CES-D) [ Time Frame: 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) [ Time Frame: Day 0 ]Evaluation of anxiety disorder defined by a score> 22 on the BAI scale
- Apathy Inventory (AI) [ Time Frame: Day 0 ]Apathetic syndrome defined by a score > 2 on AI.
- Experience Sampling Method (ESM) evaluations [ Time Frame: During 7 days ]Evaluation of daily-life mood disorders using one-week Experience Sampling Method (ESM) evaluations (smartphone)
- Actimetry [ Time Frame: During 7 days ]Circadian rhythms : sleep fragmentation and relative amplitude of circadian rhythms measured using one-week actimetry.
- Trait-Meta-Mood-Scale (TMMS) [ Time Frame: Day 0 ]Evaluation of emotional dysregulation
- Interpersonal Reactivity Index (IRI) [ Time Frame: Day 0 ]Evaluation of emotional dysregulation
- Facial emotion recognition tests [ Time Frame: Day 0 ]Evaluation of emotional dysregulation
- Brain Magnetic Resonance Imaging [ Time Frame: Day 0 ]Indexes of the structural and functional integrity of emotional regulation networks
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03515486
|CHU de Bordeaux||Recruiting|
|Bordeaux, France, 33 076|
|Contact: Mathilde POLI 05 56 79 55 20 email@example.com|