Cerebellar Stroke and Mood Disorders (CERMOOD)

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Other: Post stroke mood disorders evaluation

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.

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33 076
    • CHU de Bordeaux

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Day 0
Beck Anxiety Inventory (BAI)	Evaluation of anxiety disorder defined by a score> 22 on the BAI scale	Day 0
Apathy Inventory (AI)	Apathetic syndrome defined by a score > 2 on AI.	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Experience Sampling Method (ESM) evaluations	Evaluation of daily-life mood disorders using one-week Experience Sampling Method (ESM) evaluations (smartphone)	During 7 days
Actimetry	Circadian rhythms : sleep fragmentation and relative amplitude of circadian rhythms measured using one-week actimetry.	During 7 days
Trait-Meta-Mood-Scale (TMMS)	Evaluation of emotional dysregulation	Day 0
Trait-Meta-Mood-Scale (TMMS)	Evaluation of emotional dysregulation	24 to 48 months
Interpersonal Reactivity Index (IRI)	Evaluation of emotional dysregulation	Day 0
Interpersonal Reactivity Index (IRI)	Evaluation of emotional dysregulation	24 to 48 months
Facial emotion recognition tests	Evaluation of emotional dysregulation	Day 0
Facial emotion recognition tests	Evaluation of emotional dysregulation	24 to 48 months
Brain Magnetic Resonance Imaging	Indexes of the structural and functional integrity of emotional regulation networks	Day 0
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	24 to 48 months
Beck Anxiety Inventory (BAI)	Evaluation of anxiety disorder defined by a score> 22 on the BAI scale	24 to 48 months
Apathy Inventory (AI)	Apathetic syndrome defined by a score > 2 on AI.	24 to 48 months

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2017
• Primary Completion (Actual): March 30, 2021
• Study Completion (Actual): March 30, 2021

Study Registration Dates

• First Submitted: April 5, 2018
• First Submitted That Met QC Criteria: May 2, 2018
• First Posted (Actual): May 3, 2018

Study Record Updates

• Last Update Posted (Actual): July 16, 2021
• Last Update Submitted That Met QC Criteria: July 15, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Depression; Stroke; Anxiety; Mood; Magnetic resonance imaging (MRI); Cerebellum
• Additional Relevant MeSH Terms: Mental Disorders; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Mood Disorders
• Other Study ID Numbers: CHUBX 2015/36

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No