Exploring brain injury effects on cognitive function
Brain Injury and Cognitive Function: Neuropsychology and Neuroimaging
NA · Institut National de la Santé Et de la Recherche Médicale, France · NCT05922748
This study is trying to see how brain injuries affect thinking skills in people with unique challenges like trouble reading or recognizing things.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 1500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut National de la Santé Et de la Recherche Médicale, France (other gov) |
| Locations | 1 site (Paris, Île De France) |
| Trial ID | NCT05922748 on ClinicalTrials.gov |
What this trial studies
This exploratory study aims to understand the cerebral mechanisms behind cognitive deficits caused by brain lesions. It utilizes a single-case approach, focusing on patients with rare behavioral profiles such as alexia or agnosia. The study employs various non-invasive imaging techniques, including MRI, MEG, and EEG, to gather detailed information about brain function and structure. Participants will undergo visual or auditory tasks while their brain activity is monitored to identify the underlying causes of their cognitive impairments.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with cerebral lesions or cognitive impairments due to traumatic injuries or congenital conditions.
Not a fit: Patients with significant visual or auditory deficits that interfere with imaging tasks may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic and therapeutic strategies for patients with cognitive deficits following brain injuries.
How similar studies have performed: Previous studies using similar combined neuroimaging approaches have shown success in understanding cognitive deficits, indicating a promising avenue for this research.
Eligibility criteria
Show full inclusion / exclusion 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. 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
Where this trial is running
Paris, Île De France
- ICM - Paris Brain Institute — Paris, Île De France, France (RECRUITING)
Study contacts
- Study coordinator: Paolo Bartolomeo, MD PhD DR2
- Email: paolo.bartolomeo@icm-institute.org
- Phone: +33157274000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cerebral Lesion, Cognitive Deficit Following Brain Lesions, neuroimaging, cognitive deficit, MEG, EEG, MRI