Cerebellar Stroke and Mood Disorders

Stroke Clinical Trial

— CERMOOD  

Official title:

Cerebellar Stroke and Mood Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03515486
• Other study ID #: CHUBX 2015/36
• Status: Completed
• Phase: N/A
• Start date: January 16, 2017
• Est. completion date: March 30, 2021

Study information

• Verified date: July 2021
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: March 30, 2021
• Est. primary completion date: March 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Mood Disorders
• Stroke

Intervention

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

Locations

Country	Name	City	State
France	CHU de Bordeaux	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

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