Neuropsychological and Brain Medical Imaging Study in Patients With Brain Damage

NCT ID: NCT01849549

Last Updated: 2026-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 346 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2022-03-01

Brief Summary

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.

Conditions

Cerebrovascular Disorders; Brain Lesions; Degenerative Diseases; Developmental Pathology

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

brain damaged subjects

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

Group Type: EXPERIMENTAL

Neuropsychological testing

Intervention Type: BEHAVIORAL

Experimental test about cognitive deficit of interest and standard neuropsychological tests.

MRI

Intervention Type: OTHER

Anatomical, diffusion, and/or functional MRI

healthy volunteers

healthy controls

Group Type: SHAM_COMPARATOR

Neuropsychological testing

Intervention Type: BEHAVIORAL

Experimental test about cognitive deficit of interest and standard neuropsychological tests.

MRI

Intervention Type: OTHER

Anatomical, diffusion, and/or functional MRI

Interventions

Neuropsychological testing

Experimental test about cognitive deficit of interest and standard neuropsychological tests.

Intervention Type: BEHAVIORAL

MRI

Anatomical, diffusion, and/or functional MRI

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Rouen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Wallon, Doctor

Role: PRINCIPAL_INVESTIGATOR

Neurology Department

Locations

CHU - Hôpitaux de Rouen

Rouen, , France

Countries

France

Other Identifiers

2012-A01332-41

Identifier Type: OTHER

Identifier Source: secondary_id

2012/191/HP

Identifier Type: -

Identifier Source: org_study_id