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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
Sponsor:
Information provided by (Responsible Party):
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 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.

Condition or disease Intervention/treatment Phase
Stroke Other: Post stroke mood disorders evaluation Not Applicable

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 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.


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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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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

  2. Beck Anxiety Inventory (BAI) [ Time Frame: Day 0 ]
    Evaluation of anxiety disorder defined by a score> 22 on the BAI scale

  3. Apathy Inventory (AI) [ Time Frame: Day 0 ]
    Apathetic syndrome defined by a score > 2 on AI.


Secondary Outcome Measures :
  1. 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)

  2. Actimetry [ Time Frame: During 7 days ]
    Circadian rhythms : sleep fragmentation and relative amplitude of circadian rhythms measured using one-week actimetry.

  3. Trait-Meta-Mood-Scale (TMMS) [ Time Frame: Day 0 ]
    Evaluation of emotional dysregulation

  4. Interpersonal Reactivity Index (IRI) [ Time Frame: Day 0 ]
    Evaluation of emotional dysregulation

  5. Facial emotion recognition tests [ Time Frame: Day 0 ]
    Evaluation of emotional dysregulation

  6. Brain Magnetic Resonance Imaging [ Time Frame: Day 0 ]
    Indexes of the structural and functional integrity of emotional regulation networks



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria :

  • 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

Exclusion Criteria :

  • 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

Information from the National Library of Medicine

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


Locations
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France
CHU de Bordeaux Recruiting
Bordeaux, France, 33 076
Contact: Mathilde POLI    05 56 79 55 20    mathilde.poli@chu-bordeaux.fr   
Sponsors and Collaborators
University Hospital, Bordeaux

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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT03515486     History of Changes
Other Study ID Numbers: CHUBX 2015/36
First Posted: May 3, 2018    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Bordeaux:
Stroke
Cerebellum
Depression
Anxiety
Mood
Magnetic resonance imaging (MRI)
Additional relevant MeSH terms:
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Stroke
Mood Disorders
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Mental Disorders