StrokeCERMOODNCT03515486
Cerebellar Stroke and Mood Disorders
A study testing Post stroke mood disorders evaluation in people with Stroke, run by University Hospital, Bordeaux at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Stroke
- What is being tested?
- Post stroke mood disorders evaluation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteFrance
- Study dates
- 16 Jan 2017to 30 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- Pregnancy
- MRI contra-indication(pacemaker, claustrophobia ...)
- Non affiliated to the French social insurance
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Post stroke mood disorders evaluation
- Keywords
- Stroke, Cerebellum, Depression, Anxiety, Mood, Magnetic resonance imaging (MRI)
- Medical subject headings
- Stroke, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Post stroke mood disorders evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 0
Beck Anxiety Inventory (BAI)
Evaluation of anxiety disorder defined by a score> 22 on the BAI scale
Measured: Day 0
Apathy Inventory (AI)
Apathetic syndrome defined by a score > 2 on AI.
Measured: Day 0
Secondary outcomes (12)
Experience Sampling Method (ESM) evaluations
Evaluation of daily-life mood disorders using one-week Experience Sampling Method (ESM) evaluations (smartphone)
Measured: During 7 days
Actimetry
Circadian rhythms : sleep fragmentation and relative amplitude of circadian rhythms measured using one-week actimetry.
Measured: During 7 days
Trait-Meta-Mood-Scale (TMMS)
Evaluation of emotional dysregulation
Measured: Day 0
Trait-Meta-Mood-Scale (TMMS)
Evaluation of emotional dysregulation
Measured: 24 to 48 months
Interpersonal Reactivity Index (IRI)
Evaluation of emotional dysregulation
Measured: Day 0
Interpersonal Reactivity Index (IRI)
Evaluation of emotional dysregulation
Measured: 24 to 48 months
Facial emotion recognition tests
Evaluation of emotional dysregulation
Measured: Day 0
Facial emotion recognition tests
Evaluation of emotional dysregulation
Measured: 24 to 48 months
Brain Magnetic Resonance Imaging
Indexes of the structural and functional integrity of emotional regulation networks
Measured: 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
Measured: 24 to 48 months
Beck Anxiety Inventory (BAI)
Evaluation of anxiety disorder defined by a score> 22 on the BAI scale
Measured: 24 to 48 months
Apathy Inventory (AI)
Apathetic syndrome defined by a score > 2 on AI.
Measured: 24 to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2018
- Study start16 Jan 2017
- Primary completion30 Mar 2021
- Study completion30 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03515486
- Sponsor's protocol ID
- CHUBX 2015/36
- Other IDs
- 2016-A01168-43
- Acronym
- CERMOOD
- Status last verified
- Jul 2021
- First submitted
- 5 Apr 2018
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39630367
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebellar Stroke and Mood Disorders
- ClinicalTrials.gov ID
- NCT03515486
- Acronym / sponsor ID
- CERMOOD / CHUBX 2015/36
- Conditions
- Stroke
- Keywords
- Stroke, Cerebellum, Depression, Anxiety, Mood, Magnetic resonance imaging (MRI)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 16 Jan 2017 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 3 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post-stroke mood disorders evaluation | Experimental | Other: Post stroke mood disorders evaluationEach 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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…)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Post stroke mood disorders evaluationEach 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 |
Primary outcome
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
Beck Anxiety Inventory (BAI)
Time frame: Day 0
Evaluation of anxiety disorder defined by a score> 22 on the BAI scale
Apathy Inventory (AI)
Time frame: Day 0
Apathetic syndrome defined by a score > 2 on AI.
12 secondary outcomes
Experience Sampling Method (ESM) evaluations
Time frame: During 7 days
Actimetry
Time frame: During 7 days
Trait-Meta-Mood-Scale (TMMS)
Time frame: Day 0
Trait-Meta-Mood-Scale (TMMS)
Time frame: 24 to 48 months
Interpersonal Reactivity Index (IRI)
Time frame: Day 0
Interpersonal Reactivity Index (IRI)
Time frame: 24 to 48 months
Facial emotion recognition tests
Time frame: Day 0
Facial emotion recognition tests
Time frame: 24 to 48 months
Brain Magnetic Resonance Imaging
Time frame: Day 0
Center of Epidemiological Studies-Depression scale (CES-D)
Time frame: 24 to 48 months
Beck Anxiety Inventory (BAI)
Time frame: 24 to 48 months
Apathy Inventory (AI)
Time frame: 24 to 48 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Results publication: PubMed 39630367Duttagupta 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Post stroke mood disorders evaluation in people with Stroke, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Center of Epidemiological Studies-Depression scale (CES-D) (time frame: Day 0). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03515486, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026; AzTrials last refreshed its copy on 30 Oct 2026.