NCT03515486

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 16, 2017

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 5, 2018

Completed
28 days until next milestone

First Posted

Study publicly available on registry

May 3, 2018

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2021

Completed
Last Updated

May 14, 2026

Status Verified

July 1, 2021

Enrollment Period

4.2 years

First QC Date

April 5, 2018

Last Update Submit

May 11, 2026

Conditions

Stroke

Keywords

StrokeCerebellumDepressionAnxietyMoodMagnetic resonance imaging (MRI)

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (12)

  • Experience Sampling Method (ESM) evaluations

    During 7 days

  • Actimetry

    During 7 days

  • Trait-Meta-Mood-Scale (TMMS)

    Day 0

  • Trait-Meta-Mood-Scale (TMMS)

    24 to 48 months

  • Interpersonal Reactivity Index (IRI)

    Day 0

  • +7 more secondary outcomes

Study Arms (1)

Post-stroke mood disorders evaluation

EXPERIMENTAL

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

Interventions

Post stroke mood disorders evaluationOTHER

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

Post-stroke mood disorders evaluation

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Bordeaux

Bordeaux, 33 076, France

Location

Related Publications (1)

  • Duttagupta S, Chanraud S, Sebag L, Mayo W, Catheline G, Poli M, Liegey JS, Sibon I, Berthoz-Landron S. Associating Disrupted Intrinsic Functional Networks with Cognitive and Socio-Affective Skills Following Cerebellar Stroke. Cerebellum. 2024 Dec 4;24(1):1. doi: 10.1007/s12311-024-01757-z.

    PMID: 39630367RESULT

MeSH Terms

Conditions

StrokeDepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBehavioral SymptomsBehaviorMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2018

First Posted

May 3, 2018

Study Start

January 16, 2017

Primary Completion

March 30, 2021

Study Completion

March 30, 2021

Last Updated

May 14, 2026

Record last verified: 2021-07

Locations

FR(1)