Skip to main content
OpenTrials
Completed

NCT Number: NCT03515486

Cerebellar Stroke and Mood Disorders

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Bordeaux

Bordeaux, 33 076, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Post stroke mood disorders evaluation

Other

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 outcomes

  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 outcomes

  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. Trait-Meta-Mood-Scale (TMMS)

    Time frame: 24 to 48 months

    Evaluation of emotional dysregulation

  5. Interpersonal Reactivity Index (IRI)

    Time frame: Day 0

    Evaluation of emotional dysregulation

  6. Interpersonal Reactivity Index (IRI)

    Time frame: 24 to 48 months

    Evaluation of emotional dysregulation

  7. Facial emotion recognition tests

    Time frame: Day 0

    Evaluation of emotional dysregulation

  8. Facial emotion recognition tests

    Time frame: 24 to 48 months

    Evaluation of emotional dysregulation

  9. Brain Magnetic Resonance Imaging

    Time frame: Day 0

    Indexes of the structural and functional integrity of emotional regulation networks

  10. Center of Epidemiological Studies-Depression scale (CES-D)

    Time frame: 24 to 48 months

    Evaluation of depressive syndrome defined by a score> 17 for men and> 23 for women according to the CES-D

  11. Beck Anxiety Inventory (BAI)

    Time frame: 24 to 48 months

    Evaluation of anxiety disorder defined by a score> 22 on the BAI scale

  12. Apathy Inventory (AI)

    Time frame: 24 to 48 months

    Apathetic syndrome defined by a score > 2 on AI.

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Acronym: CERMOOD

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
May 3, 2018
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.