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Focal Brain InjuryLESCOGNCT04182087

Cognitive Function Assessment in Patients With Focal Brain Injury

An observational study of Focal Brain Injury and Cognition, run by University Hospital, Grenoble at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Focal Brain Injury, Cognition
What is being tested?
Cognitive tasks
How many people
400 participants
Where
1 siteFrance
Study dates
7 Feb 2020to 6 Feb 2030
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Philippe Kahane, MD, PhD contact

+33 476 765 488

pkahane@chu-grenoble.fr

Julien Bastin, PhD contact

+33 456 520 627

julien.bastin@univ-grenoble-alpes.fr

France1 site, 1 recruiting

  • University Hospital, Grenoble

    Grenoble, 38043

    Philippe Kahane, MD/PhD, +33 476 765 488, pkahane@chu-grenoble.fr

    Julien Bastin, PhD, +33 456 520 627, julien.bastin@univ-grenoble-alpes.fr

    Recruiting

Other trials in France

About this study

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.

Read the 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.

Being tested
Cognitive tasks
Keywords
Behavioral performance, Cortical resection, Stroke
Medical subject headings
Brain Injuries, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive tasksBehavioural

    Attention, language, memory, decision-making or executive functions

Study groups in NCT04182087
Study groupRoleWhat they receive
Focal Brain InjuryPatients with focal brain injury (post-stroke or post-cortical resection)
Receives: Behavioral: Cognitive tasks

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 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 (1)

  1. 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).

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2019
  2. Study start7 Feb 2020
  3. Primary completion6 Feb 2030 (estimated)
  4. Study completion6 Feb 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04182087
Sponsor's protocol ID
38RC19.036
Other IDs
2019-A01094-53
Acronym
LESCOG
Status last verified
Jan 2024
First submitted
4 Oct 2019
Last updated
17 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 27311080

  • 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.

    PubMed 22396393

  • 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.

    PubMed 18390562

  • 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. 2018 Jul 6;12:40. doi: 10.3389/fninf.2018.00040. eCollection 2018.

    PubMed 30034332

  • 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.

    PubMed 15037129

  • 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.2016.08.012. Epub 2016 Aug 12.

    PubMed 27527825

  • 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.

    PubMed 16352402

  • 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.

    PubMed 22524787

  • 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.

    PubMed 15378041

  • 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.

    PubMed 28782546

Questions about this trial

What is this clinical trial studying?

An observational study of Focal Brain Injury and Cognition, run by University Hospital, Grenoble at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Philippe Kahane, MD, PhD (+33 476 765 488, pkahane@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04182087, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2024.

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