Clinical trial NCT04182087: Cognitive Function Assessment in Patients With Focal Brain Injury
Official title: Cognitive Function Assessment in Patients With Focal Brain Injury
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Focal Brain Injury
Cognition
Keywords: Behavioral performance
Cortical resection
Stroke
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: Grenoble Institut des Neurosciences
First posted: 2019-12-02
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult (Age between 18 and 70 years) patients with focal brain injury (post-stroke or post-cortical resection)

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Behavioral performance during cognitive tasks: Exploratory
timeFrame: 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 outcomes:
measure: Behavioral performance (reaction time, error rate, modeling parameters): Exploratory
timeFrame: 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)
Other outcomes:
Locations:
city: Grenoble
country: France
facility: University Hospital, Grenoble
Study officials:
affiliation: University Hospital, Grenoble
name: Philippe Kahane, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Grenoble Institute of Neurosciences
name: Julien Bastin, PhD
role: STUDY_CHAIR
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