Neuropsychological and Brain Medical Imaging Study in Patients With Brain Damage (CORAC)

University Hospital, Rouen

Status: Completed

Conditions: Brain Lesions; Developmental Pathology; Degenerative Diseases; Cerebrovascular Disorders

Treatments: Behavioral: Neuropsychological testing; Other: MRI

Study type: Interventional

Funder types: Other

Identifiers

NCT01849549

2012/191/HP

2012-A01332-41 (Other Identifier)

Details and patient eligibility

About

Two groups of subjects will be constitute: (i) patients with circumscribed brain injury (including stroke, vascular malformations, tumor or circumscribed infectious lesions) or degenerative disorders and selective cognitive disorders; (ii) healthy control subjects.

The objective of this project is to evaluate specific neuropsychological deficits and apply current brain imaging techniques (anatomical, diffusion, functional) to patients suffering from these cognitive deficits due to brain damage, in order to elucidate the brain mechanisms underlying these deficits.

Enrollment: 346 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• age between 18 and 80 years
• french language
• effective contraception for women during the study
• informed consent
• no alcohol intake the day before the exam
• for patients only, focal cerebral lesion (stroke, malformation, tumor, inflammatory, infectious, traumatic), neonatal pathology or degenerative disease with cognitive deficit

Exclusion criteria

• for healthy volunteers: previous neurological history (except non complicated migraine), previous psychiatric history (except depression with good evolution or anxiety with maximum one anxiolytic treatment), or severe cranial traumatism
• for patients: vigilance disorders, severe depression or anxiety.
• for both: psychotropic medication other than a hypnotic or an anxiolytic at low doses without dose modification for at least one month, severe visual or auditory impairment, patient without judicial or administrative liberty, measure of legal protection or no capable to express their consent, pregnancy or breastfeeding, contraindication for MRI, participation in another trial or former involvement in another trial within one month

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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346 participants in 2 patient groups

brain damaged subjects

Experimental group

Description:

patients with circumscribed brain injury, selective disorders of cognitive development or degenerative disorders responsible for focal troubles

Treatment:

Other: MRI

Behavioral: Neuropsychological testing

healthy volunteers

Sham Comparator group

Description:

healthy controls

Treatment:

Other: MRI

Behavioral: Neuropsychological testing