Cerebral Lesion Clinical Trial
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: 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.
Status | Recruiting |
Enrollment | 1500 |
Est. completion date | February 5, 2027 |
Est. primary completion date | February 5, 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. 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 |
Country | Name | City | State |
---|---|---|---|
France | ICM - Paris Brain Institute | Paris | Île De France |
Lead Sponsor | Collaborator |
---|---|
Institut National de la Santé Et de la Recherche Médicale, France |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 13 years | |
Primary | MEG (Magnetoencephalography) | MEG signals reflect changes in the magnetic field evoked by neuronal activity. They are collected and analyzed using specific analysis methods. | 13 years | |
Primary | 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. | 13 years |
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