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Neuropsychological and Brain Medical Imaging Study in Patients With Brain Damage

NCT ID: NCT01849549

Last Updated: 2016-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2019-01-31

Brief Summary

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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

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Conditions

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Cerebrovascular Disorders Brain Lesions Degenerative Diseases Developmental Pathology

Keywords

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neuropsychological Study brain Imaging

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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

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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

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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

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University Hospital, Rouen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Olivier MARTINAUD, Doctor

Role: PRINCIPAL_INVESTIGATOR

service de Neurologie

Locations

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CHU - Hôpitaux de Rouen

Rouen, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Olivier MARTINAUD, Doctor

Role: CONTACT

Phone: 2 32 88 87 40

Email: [email protected]

Other Identifiers

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2012-A01332-41

Identifier Type: OTHER

Identifier Source: secondary_id

2012/191/HP

Identifier Type: -

Identifier Source: org_study_id