Cognitive Function Assessment in Patients With Focal Brain Injury

Cognition Clinical Trial

— LESCOG  

Official title:

Cognitive Function Assessment in Patients With Focal Brain Injury

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04182087
• Other study ID #: 38RC19.036
• Secondary ID: 2019-A01094-53
• Status: Recruiting
• Start date: February 7, 2020
• Est. completion date: February 6, 2030

Study information

• Verified date: January 2024
• Source: University Hospital, Grenoble
• Contact: Philippe Kahane, MD, PhD
• Phone: +33 476 765 488
• Email: pkahane[@]chu-grenoble.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: February 6, 2030
• Est. primary completion date: February 6, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Cognition
• Focal Brain Injury
• Wounds and Injuries

Intervention

Behavioral:
• Cognitive tasks
Attention, language, memory, decision-making or executive functions

Locations

Country	Name	City	State
France	University Hospital, Grenoble	Grenoble

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Grenoble	Grenoble Institut des Neurosciences

Country where clinical trial is conducted

France, 

References & Publications (10)

Adolphs R. Human Lesion Studies in the 21st Century. Neuron. 2016 Jun 15;90(6):1151-1153. doi: 10.1016/j.neuron.2016.05.014. — View Citation

Barbey AK, Colom R, Solomon J, Krueger F, Forbes C, Grafman J. An integrative architecture for general intelligence and executive function revealed by lesion mapping. Brain. 2012 Apr;135(Pt 4):1154-64. doi: 10.1093/brain/aws021. Epub 2012 Mar 6. — View Citation

Clark L, Bechara A, Damasio H, Aitken MR, Sahakian BJ, Robbins TW. Differential effects of insular and ventromedial prefrontal cortex lesions on risky decision-making. Brain. 2008 May;131(Pt 5):1311-22. doi: 10.1093/brain/awn066. Epub 2008 Apr 3. — View Citation

Deman P, Bhattacharjee M, Tadel F, Job AS, Riviere D, Cointepas Y, Kahane P, David O. IntrAnat Electrodes: A Free Database and Visualization Software for Intracranial Electroencephalographic Data Processed for Case and Group Studies. Front Neuroinform. 20 — View Citation

Dronkers NF, Wilkins DP, Van Valin RD Jr, Redfern BB, Jaeger JJ. Lesion analysis of the brain areas involved in language comprehension. Cognition. 2004 May-Jun;92(1-2):145-77. doi: 10.1016/j.cognition.2003.11.002. — View Citation

Kos C, van Tol MJ, Marsman JB, Knegtering H, Aleman A. Neural correlates of apathy in patients with neurodegenerative disorders, acquired brain injury, and psychiatric disorders. Neurosci Biobehav Rev. 2016 Oct;69:381-401. doi: 10.1016/j.neubiorev.2016.08 — View Citation

Muller NG, Knight RT. The functional neuroanatomy of working memory: contributions of human brain lesion studies. Neuroscience. 2006 Apr 28;139(1):51-8. doi: 10.1016/j.neuroscience.2005.09.018. Epub 2005 Dec 15. — View Citation

Petersen SE, Posner MI. The attention system of the human brain: 20 years after. Annu Rev Neurosci. 2012;35:73-89. doi: 10.1146/annurev-neuro-062111-150525. Epub 2012 Apr 12. — View Citation

Rorden C, Karnath HO. Using human brain lesions to infer function: a relic from a past era in the fMRI age? Nat Rev Neurosci. 2004 Oct;5(10):813-9. doi: 10.1038/nrn1521. — View Citation

Sperber C, Karnath HO. On the validity of lesion-behaviour mapping methods. Neuropsychologia. 2018 Jul 1;115:17-24. doi: 10.1016/j.neuropsychologia.2017.07.035. Epub 2017 Aug 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Behavioral performance during cognitive tasks: Exploratory	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	Behavioral performance (reaction time, error rate, modeling parameters): Exploratory	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)