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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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.

Romain SCHNECKENBURGER, MD contact

0231065298

schneckenburger-r@chu-caen.fr

France1 site, 1 recruiting
  • Caen University Hospital

    Caen

    Recruiting

Other trials in France

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.

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 groups in NCT04989608
Study groupRoleWhat they receive
patients having suffered to transient ischemic accidentOtherNot described
Receives: Other: Neuroimaging
healthy volunteersOtherNot described
Receives: Other: Neuroimaging

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

  2. 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.

  1. First posted4 Aug 2021
  2. Study start17 Nov 2021
  3. Primary completion15 May 2026 (estimated)
  4. Study completion15 May 2027 (estimated)

Resources

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)
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

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.

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