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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Cerebrovascular Disorders; Brain Lesions; Degenerative Diseases; Developmental Pathology	Behavioral: Neuropsychological testing; Other: MRI	Not Applicable

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	400 participants
Allocation:	Non-Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Diagnostic
Official Title:	Anatomical Clinical Correlations. Neuropsychological and Brain Medical Imaging Study in Brain Damaged Subjects.
Study Start Date :	May 2013
Estimated Primary Completion Date :	November 2018
Estimated Study Completion Date :	January 2019

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: brain damaged subjects; patients with circumscribed brain injury, selective disorders of cognitive development or degenerative disorders responsible for focal troubles	Behavioral: Neuropsychological testing; Experimental test about cognitive deficit of interest and standard neuropsychological tests. Other: MRI; Anatomical, diffusion, and/or functional MRI
Sham Comparator: healthy volunteers; healthy controls	Behavioral: Neuropsychological testing; Experimental test about cognitive deficit of interest and standard neuropsychological tests. Other: MRI; Anatomical, diffusion, and/or functional MRI

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Cognitive deficit [ Time Frame: 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.

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Olivier MARTINAUD, Doctor	2 32 88 87 40 ext +33	olivier.martinaud@chu-rouen.fr

Locations

France
CHU - Hôpitaux de Rouen	Recruiting
Rouen, France, 76031
Principal Investigator: Olivier MARTINAUD, Doctor

Sponsors and Collaborators

University Hospital, Rouen

Investigators

Principal Investigator:	Olivier MARTINAUD, Doctor	service de Neurologie

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	University Hospital, Rouen
ClinicalTrials.gov Identifier:	NCT01849549 History of Changes
Other Study ID Numbers:	2012/191/HP; 2012-A01332-41 ( Other Identifier: Agence Nationale de sécurité du médicament et des produits de Santé )
First Posted:	May 8, 2013
Last Update Posted:	December 7, 2016
Last Verified:	December 2016

Keywords provided by University Hospital, Rouen:

neuropsychological Study; brain Imaging

Additional relevant MeSH terms:

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