Transient Ischemic AccidentCOG-TIANCT04989608
Correlation Between Cognition and Neuroimaging in TIA Patients
A study testing Neuroimaging in people with Transient Ischemic Accident, run by University Hospital, Caen at 1 site in France.
Trial summary
Context: Cognitive impairment is common after a stroke. Out of 100 patients who have suffered a stroke, 50 will develop cognitive impairment. For 16 of them, they will be responsible for an impact on autonomy (major cognitive disorder). Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Transient Ischemic Accident
- What is being tested?
- Neuroimaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 17 Nov 2021to 15 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Transient ischemic accident Group
- Patient over 60 years of age with a transient ischemic attack (focal neurological deficit of less than 24 hours without ischemic injury on diffusion MRI performed in the week following the event.)
- Patient having signed a free and informed consent to participate in the Normandy-Stroke cohort.
- Control group
- Subject over 60 years old
- Subject included in the Medit-AGEING research protocol
Show all 17Show fewer
- Subject with one or more risk factor (s) for cerebrovascular disease
- Subject not opposing the use of their data for the Cog-Tia study
- Non inclusion criteria
- Transient ischemic accident Group
- Patient with contraindications to performing a brain MRI
- Neurological co-morbidity (history of severe head trauma, dementia, brain tumor, stroke, psychosis)
- Refusal to participate in the Normandy-Stroke cohort
- Persons deprived of their liberty by a judicial or administrative decision, persons undergoing psychiatric care, persons admitted to a health or social establishment for purposes other than that of research
- Adult persons subject to a legal protection measure or unable to express their consent
- Control group
- Subject refusing to the use of their data for the Cog-Tia study
Who cannot join
- New stroke during the study participation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Cognitive Profile and Correlates in Neuroimaging After a Transient Ischemic Accident
Context:
Cognitive impairment is common after a stroke. Out of 100 patients who have suffered a stroke, 50 will develop cognitive impairment. For 16 of them, they will be responsible for an impact on autonomy (major cognitive disorder). They are conventionally attributed either to the location of the lesions or to their general volume. However, recent literature emphasizes the presence of cognitive impairment after a transient ischemic attack (TIA), when by definition the symptoms are transient and imaging without recent ischemic injury. The mechanisms of cognitive impairment in TIA are therefore poorly understood at present. There is evidence in animal models and humans for persistent brain toxicity from ischemia even in the absence of established necrosis. However, to what extent this toxicity may explain the cognitive impairment seen in TIA is not known. Indeed, the latter could just as much have the effect of vascular risk factors which significantly increase cognitive risk even in the absence of an acute event.
Read more
Objective:
The objective of the Cog-TIA program is therefore to identify whether the transient ischemic attack may be responsible for long-term structural changes in neuroimaging in the ischemic territory and whether these changes are correlated with changes in cognitive efficiency.
Material and methods:
The project is based on the Normandy-Stroke population cohort which includes patients from Caen and the surrounding area who have had a stroke or TIA. The protocol provides for neuropsychological tests evaluating the main cognitive domains at 1 year and 3 years after the initial event. The Cog-TIA project is designed as an ancillary study to the Normandy-Stroke project with the objective of including 50 patients from this cohort who presented with a transient ischemic attack. Each patient will receive a structural MRI at the same time as the neuropsychological assessments scheduled for the Normandy-Stroke study. Analyzes will be performed from T1 sequences, Proton density with centered on the hippocampus and diffusion tensors. For the T1 and proton density sequences, the analyzes will compare the volumes of the different structures longitudinally (in particular: the total hippocampal volume and of the subfields, lobar, thalamic and pallidal volumes). For the diffusion tensor analyzes, the anisotropy maps will be compared longitudinally. For each structure showing significant variation during follow-up, correlations will be made with the decline in performance on neuropsychological tests calculated using composite scores. Cognitive decline may be partly attributed to TIA if it is correlated with abnormalities in the affected hemisphere.
- Conditions
- Transient Ischemic Accident
- Being tested
- Neuroimaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuroimagingOther
realization of a neuroimaging 1 and 3 years after the transient ischemic accident
| Study group | Role | What they receive |
|---|---|---|
| patients having suffered to transient ischemic accident | Other | Not described Receives: Other: Neuroimaging |
| healthy volunteers | Other | Not described Receives: Other: Neuroimaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation coefficients between variations in cognitive performance assessed from a composite neuropsychological score and structural modifications
Calculation of correlation coefficients between variations in cognitive performance assessed from a composite neuropsychological score and structural modifications
Measured: 1 year after the transient ischemic accident
correlation coefficients between variations in cognitive performance assessed from a composite neuropsychological score and structural modifications
Calculation of correlation coefficients between variations in cognitive
Measured: 3 years after the transient ischemic accident
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2021
- Study start17 Nov 2021
- Primary completion15 May 2026 (estimated)
- Study completion15 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transient Ischemic AccidentStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04989608
- Sponsor's protocol ID
- 20-134
- Acronym
- COG-TIA
- Status last verified
- Jul 2025
- First submitted
- 22 Jul 2021
- Last updated
- 25 Jul 2025
- 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 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Profile and Correlates in Neuroimaging After a Transient Ischemic Accident
- ClinicalTrials.gov ID
- NCT04989608
- Acronym / sponsor ID
- COG-TIA / 20-134
- Conditions
- Transient Ischemic Accident
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 17 Nov 2021 (actual)
- Primary completion
- 15 May 2026 (estimated)
- Study completion
- 15 May 2027 (estimated)
- First posted
- 4 Aug 2021 (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.
Context:
Cognitive impairment is common after a stroke. Out of 100 patients who have suffered a stroke, 50 will develop cognitive impairment. For 16 of them, they will be responsible for an impact on autonomy (major cognitive disorder). They are conventionally attributed either to the location of the lesions or to their general volume. However, recent literature emphasizes the presence of cognitive impairment after a transient ischemic attack (TIA), when by definition the symptoms are transient and imaging without recent ischemic injury. The mechanisms of cognitive impairment in TIA are therefore poorly understood at present. There is evidence in animal models and humans for persistent brain toxicity from ischemia even in the absence of established necrosis. However, to what extent this toxicity may explain the cognitive impairment seen in TIA is not known. Indeed, the latter could just as much have the effect of vascular risk factors which significantly increase cognitive risk even in the absence of an acute event.
Objective:
The objective of the Cog-TIA program is therefore to identify whether the transient ischemic attack may be responsible for long-term structural changes in neuroimaging in the ischemic territory and whether these changes are correlated with changes in cognitive efficiency.
Material and methods:
The project is based on the Normandy-Stroke population cohort which includes patients from Caen and the surrounding area who have had a stroke or TIA. The protocol provides for neuropsychological tests evaluating the main cognitive domains at 1 year and 3 years after the initial event. The Cog-TIA project is designed as an ancillary study to the Normandy-Stroke project with the objective of including 50 patients from this cohort who presented with a transient ischemic attack. Each patient will receive a structural MRI at the same time as the neuropsychological assessments scheduled for the Normandy-Stroke study. Analyzes will be performed from T1 sequences, Proton density with centered on the hippocampus and diffusion tensors. For the T1 and proton density sequences, the analyzes will compare the volumes of the different structures longitudinally (in particular: the total hippocampal volume and of the subfields, lobar, thalamic and pallidal volumes). For the diffusion tensor analyzes, the anisotropy maps will be compared longitudinally. For each structure showing significant variation during follow-up, correlations will be made with the decline in performance on neuropsychological tests calculated using composite scores. Cognitive decline may be partly attributed to TIA if it is correlated with abnormalities in the affected hemisphere.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients having suffered to transient ischemic accident | Other | Other: Neuroimaging |
| healthy volunteers | Other | Other: Neuroimaging |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Transient ischemic accident Group
- Patient over 60 years of age with a transient ischemic attack (focal neurological deficit of less than 24 hours without ischemic injury on diffusion MRI performed in the week following the event.)
- Patient having signed a free and informed consent to participate in the Normandy-Stroke cohort.
- Control group
- Subject over 60 years old
Key exclusion criteria (1 listed)
- New stroke during the study participation
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 |
|---|---|---|
| Neuroimagingrealization of a neuroimaging 1 and 3 years after the transient ischemic accident | Other | healthy volunteers, patients having suffered to transient ischemic accident |
Primary outcome
correlation coefficients between variations in cognitive performance assessed from a composite neuropsychological score and structural modifications
Time frame: 1 year after the transient ischemic accident
Calculation of correlation coefficients between variations in cognitive performance assessed from a composite neuropsychological score and structural modifications
correlation coefficients between variations in cognitive performance assessed from a composite neuropsychological score and structural modifications
Time frame: 3 years after the transient ischemic accident
Calculation of correlation coefficients between variations in cognitive
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 25 Jul 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuroimaging in people with Transient Ischemic Accident, run by University Hospital, Caen 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 17 inclusion and 1 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 25 Jul 2025. 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 Romain SCHNECKENBURGER, MD (0231065298, schneckenburger-r@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
correlation coefficients between variations in cognitive performance assessed from a composite neuropsychological score and structural modifications (time frame: 1 year after the transient ischemic accident). The study lists 2 primary outcomes in all. 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 25 Jul 2025; AzTrials last refreshed its copy on 3 Nov 2026.