Acute Ischemic StrokeCOG-TRA-Y MRINCT06262529
Neurocognitive Impairment After Ischemic Stroke
A study testing Cerebral MRI in people with Acute Ischemic Stroke, run by Centre Hospitalier Universitaire de Nice at 2 sites in France.
Trial summary
Affecting more than 150,000 patients in France, stroke is a major public health issue and a leading cause of disability worldwide. In western countries, 80-85% of strokes are of ischemic subtype. This study will focus on young adults, aged 18-45, with a diagnosis of ischemic stroke. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Cerebral MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesFrance
- Study dates
- 8 Feb 2024to 9 May 2027
- 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 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age: 18 to 45 years.
- Pathology: ischemic stroke diagnosed with brain MRI as per standard clinical practice, with or without occlusion of proximal artery, anterior or posterior circulation.
- Ability to understand and complete study tests and questionnaires: fluent French speaker and reader.
- All patients must be affiliated to a social security scheme.
- Signature of informed consent form.
Who cannot join
- Pre-existing cognitive impairment (defined as CQI <78 or clinical dementia).
- Severe functional dependence prior to stroke (defined as Modified Rankin Scale MRS = score 5).
- Any neurological or psychiatric comorbidity.
- Sensory disorders: visual impairment, blindness, deafness.
- Severe acquired phasic disorders: on the expressive oral side, in the presence of an inability to express oneself, which interferes with the collection of responses to neuropsychological tests; and on the receptive oral side, in the presence of an inability to understand the instructions of neuropsychological tests. Phasic functioning is systematically assessed during hospitalization by means of the NIHSS (score ≤ 2 on the "Language" sub-test), and will be rechecked clinically and psychometrically during neuropsychological assessments using the Language Screening Test (LAST) for both expression and oral comprehension. - Severe motor disorders: inability to mobilize the dominant upper limb for written neuropsychological tests.
- Contraindication to MRI.
Show all 10Show fewer
- Pregnant women.
- HIV-positive patients: interaction of infectious pathology on cognitive functioning. Declarative, no HIV tests will be performed.
- Withdrawal of informed consent.
- Consumption of alcohol and/or narcotics on the day of neuropsychological assessments.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Not yet recruiting
cannes Hospital
Cannes, 06600
sylvain LACHAUD, s.lachaud@ch-cannes.fr
Sylvain Lachaud
- Recruiting
Nice University Hospital
Nice, 06000
Marina Passalboni, 04 92 03 27 90, passalboni.m@chu-nice.fr
barbara CASOLLA
About this study
Official title: Trajectories of Neurocognitive Impairment After Ischemic Stroke in Young Subjects
Affecting more than 150,000 patients in France, stroke is a major public health issue and a leading cause of disability worldwide. In western countries, 80-85% of strokes are of ischemic subtype. This study will focus on young adults, aged 18-45, with a diagnosis of ischemic stroke.
Studies assessing post-stroke cognition in young patients reported an alarming prevalence of cognitive impairment, affecting about 60% of stroke survivors between 4 and 12 months after the acute event. However, longitudinal data on neurocognitive trajectories (i.e., the evolution of cognitive impairment over time) in young patients with ischemic stroke are lacking. Collecting such data requires an exhaustive neuropsychological assessment and several functional evaluations, at different times, for the same patient.
Read more
Repeated neurocognitive study of young patients with ischemic stroke will enable: a description of the prevalence of impaired global cognitive efficiency, an analysis of the specific neurocognitive domains affected, and the tracing of trajectories of recovery from cognitive impairment over time, in terms of global cognitive efficiency and as a function of specific neurocognitive domains (memory, executive, attentional, social cognition, instrumental functions, fatigability, etc.).
Up to date, the clinic-radiological predictors and associated factors of neurocognitive impairment after ischemic stroke in young patients have not been studied. Ischemic stroke causes acute brain lesions of the gray matter (GM) and white matter (WM). Numerous studies suggest that cognitive health may be more closely linked to the integrity of WM than to GM. Magnetic resonance imaging (MRI), and in particular diffusion tensor imaging (DTI) sequences, analyze WM bundles. By using fiber tracking algorithms image analysis enable the WM fiber bundle reconstruction and allow quantifying the volume of lesions (pre-existing and ischemic stroke-induced) in the WM tract.
The aim of this study is to study whether the extension of pre-existing and acute white matter lesions is associated with poorer cognitive recovery after ischemic stroke, both in terms of global cognitive performance and impairment in specific neurocognitive domains.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Cerebral MRI
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cerebral MRIOther
Cerebral MRI at 72h / 3 months / 12 months
| Study group | Role | What they receive |
|---|---|---|
| Acute ischemic stroke | Experimental | Not described Receives: Other: Cerebral MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
evolution of neurocognitive disorders (trajectories of global cognitive efficiency) over 1 year after stroke
Montréal cognitive assessment (MOCA - score 0 to 30)
Measured: Between 3 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start8 Feb 2024
- Primary completion9 May 2025 (estimated)
- Study completion9 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06262529
- Sponsor's protocol ID
- 22-AOI-06
- Acronym
- COG-TRA-Y MRI
- Status last verified
- Mar 2025
- First submitted
- 8 Feb 2024
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trajectories of Neurocognitive Impairment After Ischemic Stroke in Young Subjects
- ClinicalTrials.gov ID
- NCT06262529
- Acronym / sponsor ID
- COG-TRA-Y MRI / 22-AOI-06
- Conditions
- Acute Ischemic Stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 8 Feb 2024 (actual)
- Primary completion
- 9 May 2025 (estimated)
- Study completion
- 9 May 2027 (estimated)
- First posted
- 16 Feb 2024 (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.
Affecting more than 150,000 patients in France, stroke is a major public health issue and a leading cause of disability worldwide. In western countries, 80-85% of strokes are of ischemic subtype. This study will focus on young adults, aged 18-45, with a diagnosis of ischemic stroke.
Studies assessing post-stroke cognition in young patients reported an alarming prevalence of cognitive impairment, affecting about 60% of stroke survivors between 4 and 12 months after the acute event. However, longitudinal data on neurocognitive trajectories (i.e., the evolution of cognitive impairment over time) in young patients with ischemic stroke are lacking. Collecting such data requires an exhaustive neuropsychological assessment and several functional evaluations, at different times, for the same patient.
Repeated neurocognitive study of young patients with ischemic stroke will enable: a description of the prevalence of impaired global cognitive efficiency, an analysis of the specific neurocognitive domains affected, and the tracing of trajectories of recovery from cognitive impairment over time, in terms of global cognitive efficiency and as a function of specific neurocognitive domains (memory, executive, attentional, social cognition, instrumental functions, fatigability, etc.).
Up to date, the clinic-radiological predictors and associated factors of neurocognitive impairment after ischemic stroke in young patients have not been studied. Ischemic stroke causes acute brain lesions of the gray matter (GM) and white matter (WM). Numerous studies suggest that cognitive health may be more closely linked to the integrity of WM than to GM. Magnetic resonance imaging (MRI), and in particular diffusion tensor imaging (DTI) sequences, analyze WM bundles. By using fiber tracking algorithms image analysis enable the WM fiber bundle reconstruction and allow quantifying the volume of lesions (pre-existing and ischemic stroke-induced) in the WM tract.
The aim of this study is to study whether the extension of pre-existing and acute white matter lesions is associated with poorer cognitive recovery after ischemic stroke, both in terms of global cognitive performance and impairment in specific neurocognitive domains.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute ischemic stroke | Experimental | Other: Cerebral MRI |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age: 18 to 45 years.
- Pathology: ischemic stroke diagnosed with brain MRI as per standard clinical practice, with or without occlusion of proximal artery, anterior or posterior circulation.
- Ability to understand and complete study tests and questionnaires: fluent French speaker and reader.
- All patients must be affiliated to a social security scheme.
- Signature of informed consent form.
Key exclusion criteria (10 listed)
- Pre-existing cognitive impairment (defined as CQI <78 or clinical dementia).
- Severe functional dependence prior to stroke (defined as Modified Rankin Scale MRS = score 5).
- Any neurological or psychiatric comorbidity.
- Sensory disorders: visual impairment, blindness, deafness.
- Severe acquired phasic disorders: on the expressive oral side, in the presence of an inability to express oneself, which interferes with the collection of responses to neuropsychological tests; and on the receptive oral side, in the presence of an inability to understand the instructions of neuropsychological tests. Phasic functioning is systematically assessed during hospitalization by means of the NIHSS (score ≤ 2 on the "Language" sub-test), and will be rechecked clinically and psychometrically during neuropsychological assessments using the Language Screening Test (LAST) for both expression and oral comprehension. - Severe motor disorders: inability to mobilize the dominant upper limb for written neuropsychological tests.
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 MRICerebral MRI at 72h / 3 months / 12 months | Other | Acute ischemic stroke |
Primary outcome
evolution of neurocognitive disorders (trajectories of global cognitive efficiency) over 1 year after stroke
Time frame: Between 3 months and 12 months
Montréal cognitive assessment (MOCA - score 0 to 30)
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 20 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Acute Ischemic Stroke
Not yet recruitingPhase 3
Metformin in Acute Ischemic Stroke
Acute Ischemic Stroke
Not yet recruiting
Safety of NRICM301 Added to Standard Care in Adults With Acute Ischemic Stroke
Acute Ischemic Stroke
Not yet recruitingPhase 2/3
A Phase II/III Clinical Study of SIM0811 in the Treatment of Acute Ischemic Stroke
Acute Ischemic Stroke AIS
RecruitingPhase 3
Albumin for Patients With Acute Large Vessel Occlusive Stroke Undergoing Endovascular Therapy -2
Acute Ischemic Stroke
RecruitingObservational study
FORWARD: Functional Outcomes in Real-World Treatment And Revascularization of Non-dominant and Distal M2 Occlusions
Acute Ischemic Stroke, Acute Ischemic Stroke (AIS) Related to a Distal Occlusion
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cerebral MRI in people with Acute Ischemic Stroke, run by Centre Hospitalier Universitaire de Nice at 2 sites 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 5 inclusion and 10 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 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Marina PASSALBONI (04 92 03 27 90, passalboni.m@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evolution of neurocognitive disorders (trajectories of global cognitive efficiency) over 1 year after stroke (time frame: Between 3 months and 12 months). 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 20 Mar 2025.