Neurocognitive Impairment After Ischemic Stroke (COG-TRA-Y MRI)

February 8, 2024 updated by: Centre Hospitalier Universitaire de Nice

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.

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Cannes, France, 06600
        • Not yet recruiting
        • cannes Hospital
        • Contact:
        • Principal Investigator:
          • Sylvain Lachaud
      • Nice, France, 06000
        • Recruiting
        • Nice University Hospital
        • Contact:
        • Principal Investigator:
          • barbara CASOLLA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acute ischemic stroke
Other: Cerebral MRI
Cerebral MRI at 72h / 3 months / 12 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Between 3 months and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nice

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 9, 2024

Primary Completion (Estimated)

February 9, 2025

Study Completion (Estimated)

February 9, 2027

Study Registration Dates

First Submitted

February 8, 2024

First Submitted That Met QC Criteria

February 8, 2024

First Posted (Actual)

February 16, 2024

Study Record Updates

Last Update Posted (Actual)

February 16, 2024

Last Update Submitted That Met QC Criteria

February 8, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-AOI-06

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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