Cognitive Function Assessment in Patients With Focal Brain Injury (LESCOG)

January 15, 2024 updated by: University Hospital, Grenoble

This research relates to the study of cognitive deficits related to various focal brain lesions and their localizations in the brain.

it involves building a large database of behavioural responses measured during the performance of cognitive tasks in patients with focal brain injury, to allow to better understand function of brain.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The study of patients with focal lesions is at the origin of many key discoveries in the field of neurology and cognitive neuroscience.

There are many mechanisms of injury in the brain. The investigators focus on delineated lesions (as opposed to panencephalic, infectious or traumatic lesions), including stroke, excision of intracranial expansive processes or cortectomies of epileptogenic foci.

At the CHUGA, several hundred patients are hospitalized each year for stroke, several dozen patients are operated on brain tumor and about thirty patients benefit from surgical treatment for their epilepsy.

Post-injury cognitive disorders represent a large heterogeneous class of neurological disorders. They are differentiated by various clinical and neuropsychological profiles involving different higher functions such as attention, language, memory, decision-making or executive functions. This variability observed in these disorders complicates their characterization. Especially, there is no, on a sufficiently large scale, data collection to establish whether cognitive deficits are explained by the relative contribution of the type of test used, the location of the lesion, the nature of the pathology and the post-injury delay. This requires a large cohort of patients.

The objective of this project is precisely to build a structure-function database in patients with focal brain injury (post-stroke or post-cortical resection), with the aim of conducting a transnosographic and longitudinal study of brain functions in these patients. To the knowledge of the investigators, this type of approach has not yet been proposed. Such a project should eventually lead to a better understanding of the nature of the cognitive deficits observed in different types of lesions, and to refine the correlations between structures and functions. This project is in line with the objectives set by the University Hospital Federation NeuroPsyNov, which was labeled in 2015 (Dir P. Kahane, fhu-neuropsynov.chu-grenoble.fr) and aims to encourage transnosographic and translational studies of neurological and psychiatric diseases.

Study Type

Observational

Enrollment (Estimated)

400

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
      • Grenoble, France, 38043
        • Recruiting
        • University Hospital, Grenoble
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Olivier Detante, MD/PhD
        • Sub-Investigator:
          • Stephan Chabardès, MD/PhD

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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Adult (Age between 18 and 70 years) patients with focal brain injury (post-stroke or post-cortical resection)

Description

Inclusion Criteria:

  • Male and female patients, 18-70 years old
  • A single, focal anatomical lesion of a given cerebral territory (post vascular, post surgical resection) documented by MRI
  • Intellectual ability and understanding of instructions compatible with the cognitive tasks to be performed

Exclusion Criteria:

  • Patient deprived of liberty
  • Somatic disorder likely to affect cognitive abilities
  • Pregnant or nursing woman

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Focal Brain Injury
Patients with focal brain injury (post-stroke or post-cortical resection)
Behavioral: Cognitive tasks
Attention, language, memory, decision-making or executive functions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Behavioral performance during cognitive tasks: Exploratory
Time Frame: Data collection will be done on one or more routine visits at 3, 6, 12 or 24 months post lesion (so a maximum of four two-hour sessions)
Behavioral performance during cognitive tasks evaluating attention, memory, language, executive functions and decision-making (reaction time, error rate, modeling parameters): Aggregated data depending of patient disorders linked to the localization of brain lesion and susceptible to evolve in the time (next 10 years).
Data collection will be done on one or more routine visits at 3, 6, 12 or 24 months post lesion (so a maximum of four two-hour sessions)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Behavioral performance (reaction time, error rate, modeling parameters): Exploratory
Time Frame: Data collection will be done on one or more routine visits at 3, 6, 12 or 24 months post lesion (so a maximum of four two-hour sessions)
Behavioral performance (reaction time, error rate, modeling parameters) for a given localization according to the pathology and the delay relative to the initial event (lesion) (3, 6, 12, 24 months).
Data collection will be done on one or more routine visits at 3, 6, 12 or 24 months post lesion (so a maximum of four two-hour sessions)

Collaborators and Investigators

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

Sponsor

University Hospital, Grenoble

Collaborators

Grenoble Institut des Neurosciences

Investigators

  • Principal Investigator: Philippe Kahane, MD, PhD, University Hospital, Grenoble
  • Study Chair: Julien Bastin, PhD, Grenoble Institute of Neurosciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

February 7, 2020

Primary Completion (Estimated)

February 6, 2030

Study Completion (Estimated)

February 6, 2030

Study Registration Dates

First Submitted

October 4, 2019

First Submitted That Met QC Criteria

November 29, 2019

First Posted (Actual)

December 2, 2019

Study Record Updates

Last Update Posted (Actual)

January 17, 2024

Last Update Submitted That Met QC Criteria

January 15, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 38RC19.036
  • 2019-A01094-53 (Other Identifier: ID RCB)

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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