Brain Injury and Cognitive Function

NCT ID: NCT05922748

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-05
• Study Completion Date: 2027-02-05

Brief Summary

The objective of this exploratory study is to elucidate the underlying cerebral mechanisms of cognitive deficits. To achieve this, the investigator will apply functional brain imaging techniques to patients suffering from cognitive deficits due to cerebral lesions.

The investigator will employ a "single-case" approach, suitable for studying rare behavioral profiles such as acquired reading disorders (alexia) or visual perception impairments (agnosia). If necessary, the investigator will use multiple non-invasive imaging methods in the same patients, including:

1. Magnetic Resonance Imaging (structural and functional), renowned for its spatial resolution and the diverse information it provides, and

2. Electrophysiological methods (MEG and EEG), notable for their temporal resolution.

The employed stimuli will consist of visual or auditory presentations of verbal material (words, sentences, numbers, etc.), potentially combined with the collection of simple vocal or motor responses (button presses).

The results will be interpreted by integrating the neuropsychological analysis of the deficit and the lesion topography.

Importantly, following the methodology of single-case neuropsychology, the stimulation protocols will be modulated and adapted to each individual case. Consequently, parallel data should be collected from healthy control subjects whenever necessary.

For protocol development, the investigator will also collect purely behavioral data, without brain imaging, from groups of control subjects.

Detailed Description

The study of the cerebral mechanisms underlying mental functions, specifically in humans, relies on two sources of data: the study of patients with brain lesions and neuroimaging. While neuroimaging has experienced spectacular developments in recent years, allowing for the characterization of the functional properties of multiple brain systems, only the study of patients can establish the causal involvement of these regions in the processes at hand by observing the selective deficits resulting from lesions. This logic applies not only to acquired focal lesions resulting from, for example, vascular accidents or surgical resections but also to selective developmental cognitive disorders such as dyslexia or dyscalculia, which have been shown to result from focal abnormalities in brain development.

Over the years, research teams employing this protocol have successfully utilized both approaches, and in an innovative manner, combined them in studies exploring cognitive deficits using neuroimaging. For example, Gaillard et al. (2006) and Epelbaum et al. (2008) investigated reading disorders related to small cortical lesions by combining behavioral studies, anatomical MRI, diffusion tensor imaging (DTI) of white matter tracts, functional MRI, and intracerebral recordings of evoked potentials (EPs) in the same patient. The rarity of behavioral profiles such as acquired reading disorders motivates the use of an approach known as "single-case studies." Significant advancements in neuropsychology have only been made possible through the study of single cases. In such studies, one or a few patients are examined in great detail on an individual basis, and their behavior is compared to explicit cognitive models of the specific function under investigation. Consequently, alongside standardized test batteries, evaluation protocols must necessarily be tailored and adapted to each individual case. On the other hand, group studies are not feasible for rare behavioral profiles such as acquired reading disorders (alexia) or visual perception impairments (agnosia). This unique case approach can be greatly enhanced by brain imaging. This is now achievable due to the sufficient power of functional magnetic resonance imaging (fMRI), enabling the analysis of activations in a single subject. Similarly, advancements in recording and data processing techniques in evoked potentials (EP) and magnetoencephalography (MEG) allow the analysis of individual patient performances. Furthermore, the flexible adaptation of stimulation protocols to each patient necessitates parallel data collection from a few control subjects whenever required.

Therefore, the aim of this exploratory project is to continue this work in cognitive neuroimaging, with the specific objective of comparing the results obtained from multiple non-invasive imaging methods (fMRI, EEG, and MEG) applied to patients with cerebral lesions (and to control groups of subjects as needed). In fact, within the scope of our exploratory study, the investigator aim to investigate the spatiotemporal dynamics of brain activity involved in specific higher cognitive functions in humans: language comprehension and production, mental calculation, as well as conscious and unconscious perception. The investigator will individually assess patients selected based on the nature of their deficit and the topography of their lesions, along with control subjects. Neurological patients will be followed for one year after consenting, with multiple testing and neuroimaging sessions. Patients may withdraw from the study at any time. Control subjects should be comparable to the patients in terms of age and sociocultural level and will, therefore, be matched for these variables in each patient's case. They will receive auditory stimuli through headphones or visual stimuli presented on a screen and will perform elementary tasks (memorization, comprehension, classification, production, etc.), indicating the correct response verbally or using response buttons when necessary. The investigator may refer the same subjects to different types of examinations (MRI, EP, MEG) to compare their results, which will be interpreted by integrating the neuropsychological analysis of the deficit and lesion topography. The investigator reserve the option to employ only one or two of these imaging methods in certain subjects. Additionally a group of healthy volunteers will be tested, with only the collection of their behavioral responses.

Conditions

Cerebral Lesion; Cognitive Deficit Following Brain Lesions

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Patient

suffering from brain damage

Group Type: EXPERIMENTAL

imaging

Intervention Type: OTHER

Brain activation is demonstrated by measuring signal changes in brain regions. Activations will be determined by comparison between conditions and in relation to periods of rest

Evoked Potentials

Intervention Type: OTHER

EEG signals, referenced to the right mastoid, were digitised at 125 Hz with an elliptical low-pass input filter at 49 Hz

MEG

Intervention Type: OTHER

MEG signals reflect changes in magnetic field evoked by changes in neuronal activity

Behavioural tests

Intervention Type: BEHAVIORAL

Behavioural tests will be evaluated.

healthy control subjects for imaging

healthy control subjects for imaging

Group Type: ACTIVE_COMPARATOR

imaging

Intervention Type: OTHER

Brain activation is demonstrated by measuring signal changes in brain regions. Activations will be determined by comparison between conditions and in relation to periods of rest

Evoked Potentials

Intervention Type: OTHER

EEG signals, referenced to the right mastoid, were digitised at 125 Hz with an elliptical low-pass input filter at 49 Hz

MEG

Intervention Type: OTHER

MEG signals reflect changes in magnetic field evoked by changes in neuronal activity

Behavioural tests

Intervention Type: BEHAVIORAL

Behavioural tests will be evaluated.

healthy control subjects for purely behavioural studies

healthy control subjects for purely behavioural studies

Group Type: ACTIVE_COMPARATOR

imaging

Intervention Type: OTHER

Brain activation is demonstrated by measuring signal changes in brain regions. Activations will be determined by comparison between conditions and in relation to periods of rest

Evoked Potentials

Intervention Type: OTHER

EEG signals, referenced to the right mastoid, were digitised at 125 Hz with an elliptical low-pass input filter at 49 Hz

MEG

Intervention Type: OTHER

MEG signals reflect changes in magnetic field evoked by changes in neuronal activity

Behavioural tests

Intervention Type: BEHAVIORAL

Behavioural tests will be evaluated.

Interventions

imaging

Brain activation is demonstrated by measuring signal changes in brain regions. Activations will be determined by comparison between conditions and in relation to periods of rest

Intervention Type: OTHER

Evoked Potentials

EEG signals, referenced to the right mastoid, were digitised at 125 Hz with an elliptical low-pass input filter at 49 Hz

Intervention Type: OTHER

MEG

MEG signals reflect changes in magnetic field evoked by changes in neuronal activity

Intervention Type: OTHER

Behavioural tests

Behavioural tests will be evaluated.

Intervention Type: BEHAVIORAL

Other Intervention Names

MRI

Eligibility Criteria

Inclusion Criteria

Common criteria for patients and healthy volunteers:

• Age: 18 years and older
• Affiliation with a social security system
• Signed informed consent
• No psychotropic medication intake in the week prior to the examination, and no alcohol consumption on the eve of the examination (subjects will be instructed to have a good night's sleep before the examination).

Specific criteria for patients:

• Patients must present either cerebral lesions (vascular, malformative, tumoral) or traumatic injuries, or a history of neonatal or congenital conditions that may result in selective cognitive impairments, or congenital or acquired visual perception disorders.

Common criteria for patients and volunteers:

• Pregnant, lactating, or postpartum women (except for purely behavioral tests).
• Individuals with visual or auditory deficits that would interfere with the tasks to be performed during brain imaging acquisition.
• Contraindications for MRI (except for purely behavioral tests):
• Cardiac or neural stimulation devices
• Ferromagnetic surgical clips
• Cochlear implants
• Intra-ocular metallic foreign bodies or objects in the nervous system
• Implants or metallic objects that may concentrate the radiofrequency field
• Lack of informed consent
• Claustrophobia

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

ICM - Paris Brain Institute

Paris, Île-de-France Region, France

Site Status: RECRUITING

Countries

France

Central Contacts

Paolo Bartolomeo, MD PhD DR2

Role: CONTACT

paolo.bartolomeo@icm-institute.org

+33157274000

Facility Contacts

Paolo Bartolomeo, MD PhD DR2

Role: primary

paolo.bartolomeo@icm-institute.org

+33685711362

Other Identifiers

2013-A01207-38

Identifier Type: REGISTRY

Identifier Source: secondary_id

C13-41

Identifier Type: -

Identifier Source: org_study_id