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Cerebellar Stroke and Mood Disorders (CERMOOD)

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Post stroke mood disorders evaluation
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Stroke focused on measuring Stroke, Cerebellum, Depression, Anxiety, Mood, Magnetic resonance imaging (MRI)

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de Bordeaux

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Post-stroke mood disorders evaluation

Arm Description

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.

Outcomes

Primary Outcome Measures

Center of Epidemiological Studies-Depression scale (CES-D)
Evaluation of depressive syndrome defined by a score> 17 for men and> 23 for women according to the CES-D
Beck Anxiety Inventory (BAI)
Evaluation of anxiety disorder defined by a score> 22 on the BAI scale
Apathy Inventory (AI)
Apathetic syndrome defined by a score > 2 on AI.

Secondary Outcome Measures

Experience Sampling Method (ESM) evaluations
Evaluation of daily-life mood disorders using one-week Experience Sampling Method (ESM) evaluations (smartphone)
Actimetry
Circadian rhythms : sleep fragmentation and relative amplitude of circadian rhythms measured using one-week actimetry.
Trait-Meta-Mood-Scale (TMMS)
Evaluation of emotional dysregulation
Trait-Meta-Mood-Scale (TMMS)
Evaluation of emotional dysregulation
Interpersonal Reactivity Index (IRI)
Evaluation of emotional dysregulation
Interpersonal Reactivity Index (IRI)
Evaluation of emotional dysregulation
Facial emotion recognition tests
Evaluation of emotional dysregulation
Facial emotion recognition tests
Evaluation of emotional dysregulation
Brain Magnetic Resonance Imaging
Indexes of the structural and functional integrity of emotional regulation networks
Center of Epidemiological Studies-Depression scale (CES-D)
Evaluation of depressive syndrome defined by a score> 17 for men and> 23 for women according to the CES-D
Beck Anxiety Inventory (BAI)
Evaluation of anxiety disorder defined by a score> 22 on the BAI scale
Apathy Inventory (AI)
Apathetic syndrome defined by a score > 2 on AI.

Full Information

First Posted
April 5, 2018
Last Updated
July 15, 2021
Sponsor
University Hospital, Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT03515486
Brief Title
Cerebellar Stroke and Mood Disorders
Acronym
CERMOOD
Official Title
Cerebellar Stroke and Mood Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
January 16, 2017 (Actual)
Primary Completion Date
March 30, 2021 (Actual)
Study Completion Date
March 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Cerebellum, Depression, Anxiety, Mood, Magnetic resonance imaging (MRI)

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Post-stroke mood disorders evaluation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Post stroke mood disorders evaluation
Intervention Description
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 Measure Information:
Title
Center of Epidemiological Studies-Depression scale (CES-D)
Description
Evaluation of depressive syndrome defined by a score> 17 for men and> 23 for women according to the CES-D
Time Frame
Day 0
Title
Beck Anxiety Inventory (BAI)
Description
Evaluation of anxiety disorder defined by a score> 22 on the BAI scale
Time Frame
Day 0
Title
Apathy Inventory (AI)
Description
Apathetic syndrome defined by a score > 2 on AI.
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
Experience Sampling Method (ESM) evaluations
Description
Evaluation of daily-life mood disorders using one-week Experience Sampling Method (ESM) evaluations (smartphone)
Time Frame
During 7 days
Title
Actimetry
Description
Circadian rhythms : sleep fragmentation and relative amplitude of circadian rhythms measured using one-week actimetry.
Time Frame
During 7 days
Title
Trait-Meta-Mood-Scale (TMMS)
Description
Evaluation of emotional dysregulation
Time Frame
Day 0
Title
Trait-Meta-Mood-Scale (TMMS)
Description
Evaluation of emotional dysregulation
Time Frame
24 to 48 months
Title
Interpersonal Reactivity Index (IRI)
Description
Evaluation of emotional dysregulation
Time Frame
Day 0
Title
Interpersonal Reactivity Index (IRI)
Description
Evaluation of emotional dysregulation
Time Frame
24 to 48 months
Title
Facial emotion recognition tests
Description
Evaluation of emotional dysregulation
Time Frame
Day 0
Title
Facial emotion recognition tests
Description
Evaluation of emotional dysregulation
Time Frame
24 to 48 months
Title
Brain Magnetic Resonance Imaging
Description
Indexes of the structural and functional integrity of emotional regulation networks
Time Frame
Day 0
Title
Center of Epidemiological Studies-Depression scale (CES-D)
Description
Evaluation of depressive syndrome defined by a score> 17 for men and> 23 for women according to the CES-D
Time Frame
24 to 48 months
Title
Beck Anxiety Inventory (BAI)
Description
Evaluation of anxiety disorder defined by a score> 22 on the BAI scale
Time Frame
24 to 48 months
Title
Apathy Inventory (AI)
Description
Apathetic syndrome defined by a score > 2 on AI.
Time Frame
24 to 48 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
CHU de Bordeaux
City
Bordeaux
ZIP/Postal Code
33 076
Country
France

12. IPD Sharing Statement

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