StrokeSTROKEMNCT05595005
Neural Bases of Post-stroke Emotion Perception Disorders
An observational study of Stroke and Stroke Sequelae, run by University Hospital, Lille at 1 site in France.
Trial summary
This monocentric physiological study will evaluate the neural bases of visual recognition of emotions in stroke patients vs. healthy controls using MRI (functional and structural connectivity) and EEG. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke, Stroke Sequelae, Emotions
- How many people
- 2 participants
- Where
- 1 siteFrance
- Study dates
- 16 Feb 2024to 16 Feb 2026
- Phase
- Observational
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patient group: 40 subjects Healthy control group: 40 subject
Who may be able to join
- Stroke group:
- Man or Woman
- Age 18-80y
- Unique stroke, ischemic or hemorrhagic
- at the chronic phase (< 6 months)
- Written informed consent
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- subject having a social insurance
- Subject who consent to complete all the study's experiments
- Healthy controls group:
- Man or Woman
- Age 18-80y
- No history of neurological or psychiatric disease.
Who cannot join
- Stroke group
- Subject who is unable to consent (due to dementia, severe aphasia, psychiatric disorder...)
- History of other neurologic disorders
- Significant le vel of depression or anxiety, assessed by the STAI and the BDI questionnaires
- Non corrected visual loss
- Subjects suffering from visual neglect (assessed by the Bells Test and a bisection test (20mm)
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- contra-indications to MRI
- pregnant or breastfeeding woman
- Women of childbearing age without effective contraception
- Healthy controls group
- Subject who is unable to consent (due to dementia, severe aphasia, psychiatric disorder...)
- History of neurologic disorders
- Significant level of depression or anxiety, assessed by the STAI and the BDI questionnaires
- Non-corrected visual loss
- contra-indications to MRI
- pregnant or breastfeeding woman
- Women of childbearing age without effective contraception
Trial locations and contacts
1 site in 1 country.
About this study
This monocentric physiological study will evaluate the neural bases of visual recognition of emotions in stroke patients vs. healthy controls using MRI (functional and structural connectivity) and EEG.
Read the detailed description
This monocentric physiological study will evaluate the neural bases of visual recognition of emotions in stroke patients vs healthy controls (2 groups of 40 subjects). It will include functional MRI, structural MRI (disconnectome), EEG, and behavioral assessments of emotion recognition and executive functions.
- Conditions
- Stroke, Stroke Sequelae, Emotions
- Keywords
- stroke, emotions, neural bases
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Stroke | Stroke patients (ischemic or hemorrhagic) in the chronic phase (> 6 months) | |
| Healthy controls | Healthy adult controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
BOLD signal when fear visual recognition
Compare correlations of cerebral functional activations (BOLD) by fMRI between groups when stimulus = fear
Measured: 1 day
Secondary outcomes (9)
BOLD signal when happiness visual recognition
Compare correlations of cerebral functional activations (BOLD) by fMRI between groups when stimulus = happiness
Measured: 1 day
Electrical connectivity (EEG) when fear visual recognition
Compare cerebral networks activated by a fear visual task recognition in both groups
Measured: 1 day
Electrical connectivity (EEG) when fear happiness visual recognition
Compare cerebral networks activated by a happiness visual task recognition in both groups
Measured: 1 day
Electrical connectivity (EEG) when emotions auditory recognition
Compare cerebral networks activated by an auditory task recognition in both groups
Measured: 1 day
Relationship between behavioral performance and cerebral networks
Correlations between fMRI and EEG networks vs. behavioral performance (emotion recognition)
Measured: 1 day
Structural connectivity
Disconnectome maps in the stroke patients group
Measured: 1 day
Relationship between emotional self-assessment and cerebral networks
Correlation between the ESQ (emotional state questionnaire) and cerebral connectivity (EEG) and fMRI networks
Measured: 1 day
Relationship between the behavioural performance in emotion recognition and executive functions
Correlation between behavioral performance in emotion recognition (Eckman Test) and executive functions (Stroop Test) in the stroke group
Measured: 1 day
Relationship between lesion characteristics and the behavioral performance in emotion recognition
Correlation between lesion volume and the behavioural performance in emotion recognition (Eckman Test)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2022
- Study start16 Feb 2024
- Primary completion16 Feb 2026
- Study completion16 Feb 2026
Why it stopped: sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Groupement Interrégional de Recherche Clinique et d'Innovation
- Responsible party
- Sponsor
- Investigators
- Etienne Allart, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05595005
- Sponsor's protocol ID
- 2019_12
- Other IDs
- 2020-A00193-36
- Acronym
- STROKEM
- Status last verified
- May 2026
- First submitted
- 18 Oct 2022
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Bases of Post-stroke Emotion Perception Disorders
- ClinicalTrials.gov ID
- NCT05595005
- Acronym / sponsor ID
- STROKEM / 2019_12
- Conditions
- Stroke, Stroke Sequelae, Emotions
- Keywords
- stroke, emotions, neural bases
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: sponsor decision
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Groupement Interrégional de Recherche Clinique et d'Innovation
- Study start
- 16 Feb 2024 (actual)
- Primary completion
- 16 Feb 2026 (actual)
- Study completion
- 16 Feb 2026 (actual)
- First posted
- 26 Oct 2022 (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.
This monocentric physiological study will evaluate the neural bases of visual recognition of emotions in stroke patients vs. healthy controls using MRI (functional and structural connectivity) and EEG.
Detailed description
This monocentric physiological study will evaluate the neural bases of visual recognition of emotions in stroke patients vs healthy controls (2 groups of 40 subjects). It will include functional MRI, structural MRI (disconnectome), EEG, and behavioral assessments of emotion recognition and executive functions.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stroke | – | –Stroke patients (ischemic or hemorrhagic) in the chronic phase (> 6 months) |
| Healthy controls | – | –Healthy adult controls |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patient group: 40 subjects Healthy control group: 40 subject
Key inclusion criteria (12 listed)
- Man or Woman
- Age 18-80y
- Unique stroke, ischemic or hemorrhagic
- at the chronic phase (< 6 months)
- Written informed consent
Key exclusion criteria (17 listed)
- Stroke group
- Subject who is unable to consent (due to dementia, severe aphasia, psychiatric disorder...)
- History of other neurologic disorders
- Significant le vel of depression or anxiety, assessed by the STAI and the BDI questionnaires
- Non corrected visual loss
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
BOLD signal when fear visual recognition
Time frame: 1 day
Compare correlations of cerebral functional activations (BOLD) by fMRI between groups when stimulus = fear
9 secondary outcomes
BOLD signal when happiness visual recognition
Time frame: 1 day
Electrical connectivity (EEG) when fear visual recognition
Time frame: 1 day
Electrical connectivity (EEG) when fear happiness visual recognition
Time frame: 1 day
Electrical connectivity (EEG) when emotions auditory recognition
Time frame: 1 day
Relationship between behavioral performance and cerebral networks
Time frame: 1 day
Structural connectivity
Time frame: 1 day
Relationship between emotional self-assessment and cerebral networks
Time frame: 1 day
Relationship between the behavioural performance in emotion recognition and executive functions
Time frame: 1 day
Relationship between lesion characteristics and the behavioral performance in emotion recognition
Time frame: 1 day
Results and safety
The study was stopped early (reason given: sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
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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.
Etienne Allart, MD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Stroke Sequelae, run by University Hospital, Lille 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 12 inclusion and 17 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: stopped early, as of the sponsor's last update on 22 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 was stopped early (reason given: sponsor decision). Results are not available in the source record.
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?
BOLD signal when fear visual recognition (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 May 2026.