Brain Injury and Cognitive Function

NCT05922748 | Active Not Recruiting

• 2 other identifiers: C13-412013-A01207-38
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 1

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. 1.Magnetic Resonance Imaging (structural and functional), renowned for its spatial resolution and the diverse information it provides, and
2. 2.Electrophysiological methods (MEG and EEG), notable for their temporal resolution.

Conditions

Cognitive Deficit Following Brain Lesions; Cerebral Lesion

Keywords

neuroimaging; cognitive deficit; MEG; EEG; MRI

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (3)

Patient

EXPERIMENTAL

suffering from brain damage

Other: imaging; Other: Evoked Potentials; Other: MEG; Behavioral: Behavioural tests

healthy control subjects for imaging

ACTIVE COMPARATOR

healthy control subjects for imaging

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

Other: imaging; Other: Evoked Potentials; Other: MEG; Behavioral: Behavioural tests

Interventions

Behavioural tests BEHAVIORAL

Behavioural tests will be evaluated.

Patient; healthy control subjects for imaging; healthy control subjects for purely behavioural studies

imaging 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

Also known as: MRI

Patient; healthy control subjects for imaging; healthy control subjects for purely behavioural studies

Evoked Potentials OTHER

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

Patient; healthy control subjects for imaging; healthy control subjects for purely behavioural studies

MEG OTHER

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

Patient; healthy control subjects for imaging; healthy control subjects for purely behavioural studies

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead

Study Sites (1)

ICM - Paris Brain Institute

Paris, Île-de-France Region, 75013, France

Location

MeSH Terms

Conditions

Cognition Disorders

Interventions

X-Rays; Evoked Potentials

Condition Hierarchy (Ancestors)

Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing; Cortical Excitability; Electrophysiological Phenomena; Physiological Phenomena; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: June 14, 2023
• First Posted: June 28, 2023
• Study Start: February 5, 2014
• Primary Completion (Estimated): February 5, 2027
• Study Completion (Estimated): February 5, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

FR (1)