Neuropsychological and Brain Medical Imaging Study in Patients With Brain Damage

Not Applicable

• Conditions: Cerebrovascular Disorders; Developmental Pathology; Brain Lesions; Degenerative Diseases
• Interventions: Behavioral: Neuropsychological testing; Other: MRI

• Registration Number: NCT01849549
• Lead Sponsor: University Hospital, Rouen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-04-30
• Study Start: 2013-05
• Study First Submitted QC: 2013-05-07
• Study First Posted: 2013-05-08
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-06
• Last Update Posted: 2016-12-07
• Primary Completion: 2018-11
• Study Completion: 2019-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
healthy volunteers	MRI	healthy controls
brain damaged subjects	Neuropsychological testing	patients with circumscribed brain injury, selective disorders of cognitive development or degenerative disorders responsible for focal troubles
brain damaged subjects	MRI	patients with circumscribed brain injury, selective disorders of cognitive development or degenerative disorders responsible for focal troubles
healthy volunteers	Neuropsychological testing	healthy controls

Primary Outcome Measures

Name	Time	Method
Cognitive deficit	3 to 6 months	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.

Trial Locations

Locations (1)

CHU - Hôpitaux de Rouen; 🇫🇷 Rouen, France