LESCOG: Cognitive Function Assessment in Patients With Focal Brain Injury

Sponsor
University Hospital, Grenoble (Other)
Overall Status
Recruiting
CT.gov ID
NCT04182087
Collaborator
Grenoble Institut des Neurosciences (Other)
400
1
120
3.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Cognitive tasks

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 Design

Study Type:
Observational
Anticipated Enrollment :
400 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Cognitive Function Assessment in Patients With Focal Brain Injury
Actual Study Start Date :
Feb 7, 2020
Anticipated Primary Completion Date :
Feb 6, 2030
Anticipated Study Completion Date :
Feb 6, 2030

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Behavioral performance during cognitive tasks: Exploratory [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).

Secondary Outcome Measures

  1. Behavioral performance (reaction time, error rate, modeling parameters): Exploratory [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital, Grenoble Grenoble France 38043

Sponsors and Collaborators

  • University Hospital, Grenoble
  • Grenoble Institut des Neurosciences

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT04182087
Other Study ID Numbers:
  • 38RC19.036
  • 2019-A01094-53
First Posted:
Dec 2, 2019
Last Update Posted:
Sep 5, 2021
Last Verified:
Sep 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Grenoble
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 5, 2021