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Cerebellar Stroke and Mood Disorders

Cerebellar Stroke and Mood Disorders

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03515486
Acronym
CERMOOD
Enrollment
38
Registered
2018-05-03
Start date
2017-01-16
Completion date
2021-03-30
Last updated
2026-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

Stroke, Cerebellum, Depression, Anxiety, Mood, Magnetic resonance imaging (MRI)

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.

Interventions

OTHERPost 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

Sponsors

University Hospital, Bordeaux
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Center of Epidemiological Studies-Depression scale (CES-D)Day 0Evaluation of depressive syndrome defined by a score\> 17 for men and\> 23 for women according to the CES-D
Beck Anxiety Inventory (BAI)Day 0Evaluation of anxiety disorder defined by a score\> 22 on the BAI scale
Apathy Inventory (AI)Day 0Apathetic syndrome defined by a score \> 2 on AI.

Secondary

MeasureTime frameDescription
Experience Sampling Method (ESM) evaluationsDuring 7 daysEvaluation of daily-life mood disorders using one-week Experience Sampling Method (ESM) evaluations (smartphone)
ActimetryDuring 7 daysCircadian rhythms : sleep fragmentation and relative amplitude of circadian rhythms measured using one-week actimetry.
Trait-Meta-Mood-Scale (TMMS)Day 0Evaluation of emotional dysregulation
Interpersonal Reactivity Index (IRI)Day 0Evaluation of emotional dysregulation
Facial emotion recognition testsDay 0Evaluation of emotional dysregulation
Brain Magnetic Resonance ImagingDay 0Indexes of the structural and functional integrity of emotional regulation networks
Center of Epidemiological Studies-Depression scale (CES-D)24 to 48 monthsEvaluation of depressive syndrome defined by a score\> 17 for men and\> 23 for women according to the CES-D
Beck Anxiety Inventory (BAI)24 to 48 monthsEvaluation of anxiety disorder defined by a score\> 22 on the BAI scale
Apathy Inventory (AI)24 to 48 monthsApathetic syndrome defined by a score \> 2 on AI.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 15, 2026