Stroke IschemicBREMISSNCT06995040
BREMISS : Brain Resilience Minor Stroke Study
A study testing Cerebral MRI without contrast agent injection, saliva sample and Questionnaires in people with Stroke Ischemic, run by University Hospital, Brest at 1 site in France.
Trial summary
The objective of this clinical trial is to develop, based on patients' initial characteristics (in the first few weeks following the stroke), a predictive model of quality of life more than 4 years after the stroke in patients who have suffered a minor ischemic stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke Ischemic
- What is being tested?
- Cerebral MRI without contrast agent injection, saliva sample and Questionnaires
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 18 Jun 2025to 18 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cases of stroke in the Brest Stroke Registry (BSR)
- Ability to sign informed consent
- Patients followed-up > 4 years during the study period
- NIHSS score ≤ 5 on admission
- First stroke above 18 and before 75-year old
- Rankin before stroke < 1
- Possibility to draw saliva samples for genomic study
- Possibility to perform Cerebral MRI
Who cannot join
- Patients with transient neurological deficits resolving within one hour and normal brain imaging will be excluded.
- Not affiliated to social security
- Patient under legal protection or deprived of liberty by a judicial or administrative decision
- Patient unable to sign informed consent
- Patient whose follow-up will be impossible
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Brest
Brest, 29609
Serge TIMSIT, Pr, 298147349 ext. +33, serge.timsit@chu-brest.fr
Serge TIMSIT, Pr
About this study
Official title: Initial Predictors of Long-term Brain Resilience After Minor Ischemic Stroke: a Study Nested in the Brest Stroke Population-based Registry
The objective of this clinical trial is to develop, based on patients' initial characteristics (in the first few weeks following the stroke), a predictive model of quality of life more than 4 years after the stroke in patients who have suffered a minor ischemic stroke.
The main question it aims to answer is:
Read more
- Is it possible to predict the quality of life of patients who have suffered a minor ischemic stroke based on their initial characteristics?
To do this, retrospective and prospective data collected as part of the study will be analyzed using a conventional statistical approach and algorithms based on AI approaches in order to create a predictive model.
Participants will be asked to:
- Complete questionnaires
- Provide a saliva sample (optional)
- Undergo an MRI scan (optional)
Read the detailed description
Brain resilience: The human brain shows remarkable inter-individual differences in coping with pathological insults. This is observed in particular after ischemic stroke with patients with similar types of stroke showing very different functional outcomes ranging from complete recovery to severe disability.
Minor stroke: In population-based studies, approximately two-thirds of ischemic stroke patients have mild deficits. Minor stroke is generally defined as a National Institute of Health Stroke Scale (NIHSS) of 5 or less. The term minor stroke takes into account certain deficits but not the fact that some can have a more profound impact on quality of life than others. Minor strokes have a 30-day fatality rate very low but approximately 30% of patients with minor strokes have poor functional outcomes at 90-days. In patients with minor stroke impairment of health-related quality of life is however present in 35.8% of case at 3-months.Long term outcome (> 90-days) is less well known. An analysis of the population-based Oxford Vascular Study showed that, in minor stroke with an NIHSS < 3, the incidence of post-event dementia at 1 year was 8.2% (6.2-10.2). The 5-year risk of dementia was found associated with age, event severity, previous stroke, dysphasia, baseline cognition, low education, pre-morbid dependency, leucoaraiosis, and diabetes. Cognitive sequelae of minor strokes are frequent involving overall executive functions, attention, working memory, processing speed, visual \& verbal memory, verbal fluency and other. There is a need for big data, big imaging: many studies have less than 100 patients, none had 1000 patients
The principal objective is to develop, from initial (first weeks after stroke onset) patients' characteristics, a predictive model of quality of life more than 4 years after stroke onset in patients with minor ischemic stroke.
Patients included in the Brest Stroke Registry (all cases of stroke in patients aged above 15 years occurring in a defined area known as the "Pays de Brest", in Brittany, western France) who meet the inclusion and non-inclusion criteria will be proposed to participate to the study to have either a telephone interview or a face-to-face interview with a neurologist and a clinical research technician more than 4 years from stroke hospitalization.
In the case of telephone interview they will be proposed to have a saliva sample for DNA analysis send to their home that will need to be send back to the hospital.
In the case of face-to-face interview, patient will be proposed to have on the spot a saliva sample for DNA and a cerebral MRI.
Chaining patients from the BRE and hospital medical record: Pairing between databases-i.e BRE and hospital medical electronic record will be established.
Retrospective cohort data for baseline characteristics and prospective data for more than 4 years information.
- Conditions
- Stroke Ischemic
- Being tested
- Cerebral MRI without contrast agent injection, saliva sample, Questionnaires
- Keywords
- stroke, Predictive model
- Medical subject headings
- Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cerebral MRI without contrast agent injectionDiagnostic test
Cerebral MRI at inclusion or after
saliva sampleGenetic
Saliva sample for DNA analysis at inclusion or send to their home.
QuestionnairesOther
Quality of life and cognitive questionnaires at inclusion
| Study group | Role | What they receive |
|---|---|---|
| Minor ischemic stroke | Other | Patients registered in the Brest Stroke Registry who have been a minor stroke more than 4 years ago Receives: Diagnostic Test: Cerebral MRI without contrast agent injection; Genetic: saliva sample; Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life score
Quality of life score is evaluated with the SF-36 questionnaire. It is a dichotomized score : good or bad recovery
Measured: At inclusion
Secondary outcomes (16)
EQ5D score
It is a questionnaire to describe patient's health with 5 items (Mobility; Autonomy; Activity; Pain/Discomfort; Anxiety/Depression) with 5 anwers each (No problem/light problems/moderate problem/serious problems/incapable)
Measured: At inclusion
Stroke Impact Scale
Stroke Impact Scale includes 59 items and assesses 8 domains: Strength (4 items), Hand function (5 items), ADL/IADL (10 items), Mobility (9 items), Communication (7 items), Emotion (9 items), Memory and thinking (7 items), Participation/Role function (8 items)
Measured: At inclusion
Mortality
Mortality is collected from the Brest Stroke Registry, and concerns patients who have been stroke 4 years ago.
Measured: At inclusion
Recurrence
Recurrence is collected from the Brest Stroke Registry, and concerns patients who have been stroke 4 years ago.
Measured: At inclusion
Rankin score
It is a scale about disability after stroke. The score is between 0 (no symptom) to 5 (serious disability). The study uses Rankin score dichotomized in good [0-1] and bad [2-5] prognosis.
Measured: At inclusion
Utility-Weighted Modified Rankin Scale
The Modified Rankin Scale is a measure of functional outcome after stroke, evaluating the degree of disability or dependence in daily life. There is 7 grades ranging from 0 (no symptoms) to 6 (death).
Measured: At inclusion
WHO Disability Assessment Schedule (WHODAS)
It is an auto-questionnaire of disability in daily life. There are 15 questions with 5 anwers ranging from 0 (No disability) to 5 (extreme disability/incapability)
Measured: At inclusion
Clinical Functioning Information Tool (ClinFIT)
It is an auto-questionnaire to evaluate patient functioning. There are 30 questions, with score ranging from 0 (no problem) to 30 (complete problem).
Measured: At inclusion
Montreal Cognitive Assesment (MoCA)
It is a cognition test with 7 items (visuospatial; designation; memory; attention; langage; abstraction; orientation). The total score is ranging from 0 to 30 points.
Measured: At inclusion
Mini Mental State Examination (MMSE)
It is a cognition test with 6 items (orientation ; learning ; attention/calculation ; reminder; langage ; visuospatial constructive). The total score is ranging from 0 to 30 points.
Measured: At inclusion
Center for Epidemiologic Studies-Depression (CES-D)
It is an auto-questionnaire to evaluate depression with 20 questions. There are 6 answers with score ranging from 0 to 6 (0 : Never/very rarely ; 1: rarely; 2 :quite often; 3: frequently/always).
Measured: At inclusion
Generalized Anxiety Disorder-7 (GAD-7)
It is an auto-questionnaire for screening of generalized anxiety disorder with 7 questions. There are 4 answers : Never / Several days / More than half the days / Almost every day.
Measured: At inclusion
Primary Care PTSD Screen for DSM-5 (PTSD-5)
It is an auto-questionnaire to evaluate stroke experience. there are 5 questions with 2 answers Yes/No
Measured: At inclusion
APATHY INVENTORY IA
It is an auto-questionnaire to obtain information on the presence of apathy in patients with brain disorders. There are 3 items : emotional blunting; loss of initiative; loss of interest, with score ranging from 0 (mild) to 12 (severe).
Measured: At inclusion
Multidimensional Fatigue Inventory (MFI)
It is an auto-questionnaire to evaluate fatigue. There are 10 items with score ranging from 1 (not agree at all) to 5 (completely agree)
Measured: At inclusion
Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE)
It is a questionnaire to evaluate cognitive declin, with 16 questions, with score ranging from 1 (much better) to 5 (much worse)
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start18 Jun 2025
- Primary completion18 Dec 2027 (estimated)
- Study completion18 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke IschemicStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Retrospective cohort data for baseline characteristics and prospective data for more than 4 years information. Methodology that will be developed will include both classical statistical analysis and algorithm development based on AI approaches. * For classical statistical approach principal analysis will be analyzed with a logistic regression model allowing multivariate analysis. * AI models will be trained in Python using libraries Pytorch and Scikit-learn. We will consider a wide set of regression models to compare their performance on validation cohorts. The list includes (but is not limited to) KNNs (K-Nearest Neighbors), SVMs (Support vector machine) and deep learning models.
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Serge TIMSIT, Pr, Principal investigator, CHU de Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06995040
- Sponsor's protocol ID
- 29BRC23.0188 - BREMISS
- Acronym
- BREMISS
- Status last verified
- Feb 2026
- First submitted
- 21 May 2025
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initial Predictors of Long-term Brain Resilience After Minor Ischemic Stroke: a Study Nested in the Brest Stroke Population-based Registry
- ClinicalTrials.gov ID
- NCT06995040
- Acronym / sponsor ID
- BREMISS / 29BRC23.0188 - BREMISS
- Conditions
- Stroke Ischemic
- Keywords
- stroke, Predictive model
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 18 Jun 2025 (actual)
- Primary completion
- 18 Dec 2027 (estimated)
- Study completion
- 18 Dec 2028 (estimated)
- First posted
- 29 May 2025 (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.
The objective of this clinical trial is to develop, based on patients' initial characteristics (in the first few weeks following the stroke), a predictive model of quality of life more than 4 years after the stroke in patients who have suffered a minor ischemic stroke.
The main question it aims to answer is:
- Is it possible to predict the quality of life of patients who have suffered a minor ischemic stroke based on their initial characteristics?
To do this, retrospective and prospective data collected as part of the study will be analyzed using a conventional statistical approach and algorithms based on AI approaches in order to create a predictive model.
Participants will be asked to:
- Complete questionnaires
- Provide a saliva sample (optional)
- Undergo an MRI scan (optional)
Detailed description
Brain resilience: The human brain shows remarkable inter-individual differences in coping with pathological insults. This is observed in particular after ischemic stroke with patients with similar types of stroke showing very different functional outcomes ranging from complete recovery to severe disability.
Minor stroke: In population-based studies, approximately two-thirds of ischemic stroke patients have mild deficits. Minor stroke is generally defined as a National Institute of Health Stroke Scale (NIHSS) of 5 or less. The term minor stroke takes into account certain deficits but not the fact that some can have a more profound impact on quality of life than others. Minor strokes have a 30-day fatality rate very low but approximately 30% of patients with minor strokes have poor functional outcomes at 90-days. In patients with minor stroke impairment of health-related quality of life is however present in 35.8% of case at 3-months.Long term outcome (> 90-days) is less well known. An analysis of the population-based Oxford Vascular Study showed that, in minor stroke with an NIHSS < 3, the incidence of post-event dementia at 1 year was 8.2% (6.2-10.2). The 5-year risk of dementia was found associated with age, event severity, previous stroke, dysphasia, baseline cognition, low education, pre-morbid dependency, leucoaraiosis, and diabetes. Cognitive sequelae of minor strokes are frequent involving overall executive functions, attention, working memory, processing speed, visual \& verbal memory, verbal fluency and other. There is a need for big data, big imaging: many studies have less than 100 patients, none had 1000 patients
The principal objective is to develop, from initial (first weeks after stroke onset) patients' characteristics, a predictive model of quality of life more than 4 years after stroke onset in patients with minor ischemic stroke.
Patients included in the Brest Stroke Registry (all cases of stroke in patients aged above 15 years occurring in a defined area known as the "Pays de Brest", in Brittany, western France) who meet the inclusion and non-inclusion criteria will be proposed to participate to the study to have either a telephone interview or a face-to-face interview with a neurologist and a clinical research technician more than 4 years from stroke hospitalization.
In the case of telephone interview they will be proposed to have a saliva sample for DNA analysis send to their home that will need to be send back to the hospital.
In the case of face-to-face interview, patient will be proposed to have on the spot a saliva sample for DNA and a cerebral MRI.
Chaining patients from the BRE and hospital medical record: Pairing between databases-i.e BRE and hospital medical electronic record will be established.
Retrospective cohort data for baseline characteristics and prospective data for more than 4 years information.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Retrospective cohort data for baseline characteristics and prospective data for more than 4 years information. Methodology that will be developed will include both classical statistical analysis and algorithm development based on AI approaches. * For classical statistical approach principal analysis will be analyzed with a logistic regression model allowing multivariate analysis. * AI models will be trained in Python using libraries Pytorch and Scikit-learn. We will consider a wide set of regression models to compare their performance on validation cohorts. The list includes (but is not limited to) KNNs (K-Nearest Neighbors), SVMs (Support vector machine) and deep learning models.
| Arm | Type | Receives |
|---|---|---|
| Minor ischemic stroke | Other | Diagnostic Test: Cerebral MRI without contrast agent injection, Genetic: saliva sample, Other: QuestionnairesPatients registered in the Brest Stroke Registry who have been a minor stroke more than 4 years ago |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Cases of stroke in the Brest Stroke Registry (BSR)
- Ability to sign informed consent
- Patients followed-up > 4 years during the study period
- NIHSS score ≤ 5 on admission
- First stroke above 18 and before 75-year old
Key exclusion criteria (5 listed)
- Patients with transient neurological deficits resolving within one hour and normal brain imaging will be excluded.
- Not affiliated to social security
- Patient under legal protection or deprived of liberty by a judicial or administrative decision
- Patient unable to sign informed consent
- Patient whose follow-up will be impossible
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 |
|---|---|---|
| Cerebral MRI without contrast agent injectionCerebral MRI at inclusion or after | Diagnostic test | Minor ischemic stroke |
| saliva sampleSaliva sample for DNA analysis at inclusion or send to their home. | Genetic | Minor ischemic stroke |
| QuestionnairesQuality of life and cognitive questionnaires at inclusion | Other | Minor ischemic stroke |
Primary outcome
Quality of life score
Time frame: At inclusion
Quality of life score is evaluated with the SF-36 questionnaire. It is a dichotomized score : good or bad recovery
16 secondary outcomes
EQ5D score
Time frame: At inclusion
Stroke Impact Scale
Time frame: At inclusion
Mortality
Time frame: At inclusion
Recurrence
Time frame: At inclusion
Rankin score
Time frame: At inclusion
Utility-Weighted Modified Rankin Scale
Time frame: At inclusion
WHO Disability Assessment Schedule (WHODAS)
Time frame: At inclusion
Clinical Functioning Information Tool (ClinFIT)
Time frame: At inclusion
Montreal Cognitive Assesment (MoCA)
Time frame: At inclusion
Mini Mental State Examination (MMSE)
Time frame: At inclusion
Center for Epidemiologic Studies-Depression (CES-D)
Time frame: At inclusion
Generalized Anxiety Disorder-7 (GAD-7)
Time frame: At inclusion
Primary Care PTSD Screen for DSM-5 (PTSD-5)
Time frame: At inclusion
APATHY INVENTORY IA
Time frame: At inclusion
Multidimensional Fatigue Inventory (MFI)
Time frame: At inclusion
Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE)
Time frame: At inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
Related trials for Stroke Ischemic
RecruitingPhase 1/2
Safety and Efficacy of CG-BM1 in Ischemic Stroke
Ischemic Stroke or High-risk TIA (ABCD² ≥ 4)
Not yet recruitingPhase 3
Recombinant Human Prourokinase for Acute Ischemic Stroke in the Extended Window Selected by CT-Based Artificial Intelligence
Acute Ischemic Stroke
Recruiting
Effects of Mirror Therapy and Motor Imagery on Upper Limb Motor Functions in Middle Cerebral Artery Stroke
Stroke
Recruiting
Rapid Local Ischemic Postconditioning on Stroke After Thrombectomy
Acute Ischemic Stroke
Recruiting
Safety and Feasibility of NRICM301 Added to Usual Care for Adults With Acute Ischemic Stroke
Acute Ischemic Stroke
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.
Serge TIMSIT, Pr principal investigator
CHU de Brest
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cerebral MRI without contrast agent injection, saliva sample and Questionnaires in people with Stroke Ischemic, run by University Hospital, Brest 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 8 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 23 Feb 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Serge TIMSIT, Pr (298147349 ext. +33, serge.timsit@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life score (time frame: At inclusion). 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 23 Feb 2026.