Neuropsychological and Brain Medical Imaging Study in Patients With Brain Damage

NCT01849549 | Completed

• 2 other identifiers: 2012/191/HP2012-A01332-41
• Study Type: interventional
• Target: 346
• Locations: 1 country
• Sites: 1

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

Keywords

neuropsychological Study; brain Imaging

Outcome Measures

Primary Outcomes (1)

• Cognitive deficit

  The cognitive deficit of interest will depend on the localization of the brain lesion. The outcome measure could be a standardized neuropsychological test or an experimental test specifically elaborated for this protocol.

  3 to 6 months

Study Arms (2)

brain damaged subjects

EXPERIMENTAL

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

Behavioral: Neuropsychological testing; Other: MRI

healthy volunteers

SHAM COMPARATOR

healthy controls

Behavioral: Neuropsychological testing; Other: MRI

Interventions

MRI OTHER

Anatomical, diffusion, and/or functional MRI

brain damaged subjects; healthy volunteers

Neuropsychological testing BEHAVIORAL

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

brain damaged subjects; healthy volunteers

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

CHU - Hôpitaux de Rouen

Rouen, 76031, France

Location

MeSH Terms

Conditions

Cerebrovascular Disorders

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• David Wallon, Doctor

  Neurology Department

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 30, 2013
• First Posted: May 8, 2013
• Study Start: May 1, 2013
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: February 6, 2026

Record last verified: 2026-02

Locations

FR (1)