Cerebral LesionNCT05922748
Brain Injury and Cognitive Function
A study testing imaging, Evoked Potentials and MEG in people with Cerebral Lesion and Cognitive Deficit Following Brain Lesions, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cerebral Lesion, Cognitive Deficit Following Brain Lesions
- What is being tested?
- imaging, Evoked Potentials and MEG
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 1 siteFrance
- Study dates
- 5 Feb 2014to 5 Feb 2027
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
Show all 19Show fewer
- 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.
- NON INCLUSION CRITERIA
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Brain Injury and Cognitive Function: Neuropsychology and Neuroimaging
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:
Read more
- Magnetic Resonance Imaging (structural and functional), renowned for its spatial resolution and the diverse information it provides, and
- 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.
Read the 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.
- Being tested
- imaging, Evoked Potentials, MEG, Behavioural tests
- Keywords
- neuroimaging, cognitive deficit, MEG, EEG, MRI
- Medical subject headings
- Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
imagingOther
Also called MRI
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 PotentialsOther
EEG signals, referenced to the right mastoid, were digitised at 125 Hz with an elliptical low-pass input filter at 49 Hz
MEGOther
MEG signals reflect changes in magnetic field evoked by changes in neuronal activity
Behavioural testsBehavioural
Behavioural tests will be evaluated.
| Study group | Role | What they receive |
|---|---|---|
| Patient | Experimental | suffering from brain damage Receives: Other: imaging; Other: Evoked Potentials; Other: MEG; Behavioral: Behavioural tests |
| healthy control subjects for imaging | Active comparator | healthy control subjects for imaging Receives: Other: imaging; Other: Evoked Potentials; Other: MEG; Behavioral: Behavioural tests |
| healthy control subjects for purely behavioural studies | Active comparator | healthy control subjects for purely behavioural studies Receives: Other: imaging; Other: Evoked Potentials; Other: MEG; Behavioral: Behavioural tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI (Functional Magnetic Resonance Imaging)
Brain activation is revealed by measuring signal changes in brain regions. Activations will be determined by comparing conditions and compared to resting periods using analysis techniques.
Measured: 13 years
MEG (Magnetoencephalography)
MEG signals reflect changes in the magnetic field evoked by neuronal activity. They are collected and analyzed using specific analysis methods.
Measured: 13 years
ERPs (Event-Related Potentials)
EEG signals, referenced to the right mastoid, are digitized at 125 Hz with a low-pass elliptical input filter at 49 Hz.
Measured: 13 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2023
- Study start5 Feb 2014
- Primary completion5 Feb 2027 (estimated)
- Study completion5 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral LesionStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- We will study patients (n= 300) suffering from focal brain lesions and healthy control subjects (n= 600 for imaging, n= 600 for purely behavioural studies)
- Masking
- None (open label)
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05922748
- Sponsor's protocol ID
- C13-41
- Other IDs
- 2013-A01207-38
- Status last verified
- Apr 2026
- First submitted
- 14 Jun 2023
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Injury and Cognitive Function: Neuropsychology and Neuroimaging
- ClinicalTrials.gov ID
- NCT05922748
- Acronym / sponsor ID
- C13-41
- Keywords
- neuroimaging, cognitive deficit, MEG, EEG, MRI
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- 5 Feb 2014 (actual)
- Primary completion
- 5 Feb 2027 (estimated)
- Study completion
- 5 Feb 2027 (estimated)
- First posted
- 28 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Magnetic Resonance Imaging (structural and functional), renowned for its spatial resolution and the diverse information it provides, and
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- We will study patients (n= 300) suffering from focal brain lesions and healthy control subjects (n= 600 for imaging, n= 600 for purely behavioural studies)
| Arm | Type | Receives |
|---|---|---|
| Patient | Experimental | Other: imaging, Other: Evoked Potentials, Other: MEG, Behavioral: Behavioural testssuffering from brain damage |
| healthy control subjects for imaging | Active comparator | Other: imaging, Other: Evoked Potentials, Other: MEG, Behavioral: Behavioural testshealthy control subjects for imaging |
| healthy control subjects for purely behavioural studies | Active comparator | Other: imaging, Other: Evoked Potentials, Other: MEG, Behavioral: Behavioural testshealthy control subjects for purely behavioural studies |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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).
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| imagingAlso: MRIBrain 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 | Other | Patient, healthy control subjects for imaging, healthy control subjects for purely behavioural studies |
| Evoked PotentialsEEG signals, referenced to the right mastoid, were digitised at 125 Hz with an elliptical low-pass input filter at 49 Hz | Other | Patient, healthy control subjects for imaging, healthy control subjects for purely behavioural studies |
| MEGMEG signals reflect changes in magnetic field evoked by changes in neuronal activity | Other | Patient, healthy control subjects for imaging, healthy control subjects for purely behavioural studies |
| Behavioural testsBehavioural tests will be evaluated. | Behavioural | Patient, healthy control subjects for imaging, healthy control subjects for purely behavioural studies |
Primary outcome
MRI (Functional Magnetic Resonance Imaging)
Time frame: 13 years
Brain activation is revealed by measuring signal changes in brain regions. Activations will be determined by comparing conditions and compared to resting periods using analysis techniques.
MEG (Magnetoencephalography)
Time frame: 13 years
MEG signals reflect changes in the magnetic field evoked by neuronal activity. They are collected and analyzed using specific analysis methods.
ERPs (Event-Related Potentials)
Time frame: 13 years
EEG signals, referenced to the right mastoid, are digitized at 125 Hz with a low-pass elliptical input filter at 49 Hz.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing imaging, Evoked Potentials and MEG in people with Cerebral Lesion and Cognitive Deficit Following Brain Lesions, run by Institut National de la Santé Et de la Recherche Médicale, France 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 19 inclusion and 0 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: under way, not looking for participants, as of the sponsor's last update on 29 Apr 2026. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRI (Functional Magnetic Resonance Imaging) (time frame: 13 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Apr 2026.