Neuropsychological and Brain Medical Imaging Study in Patients With Brain Damage (CORAC)
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ClinicalTrials.gov Identifier: NCT01849549 |
Recruitment Status
:
Recruiting
First Posted
: May 8, 2013
Last Update Posted
: December 7, 2016
|
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cerebrovascular Disorders Brain Lesions Degenerative Diseases Developmental Pathology | Behavioral: Neuropsychological testing Other: MRI | Not Applicable |
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 |

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
|
- 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.

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01849549
Contact: Olivier MARTINAUD, Doctor | 2 32 88 87 40 ext +33 | olivier.martinaud@chu-rouen.fr |
France | |
CHU - Hôpitaux de Rouen | Recruiting |
Rouen, France, 76031 | |
Principal Investigator: Olivier MARTINAUD, Doctor |
Principal Investigator: | Olivier MARTINAUD, Doctor | service de Neurologie |
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 Key Record Dates |
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 |