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

This study is currently recruiting participants.
Verified December 2016 by University Hospital, Rouen
ClinicalTrials.gov Identifier:
First Posted: May 8, 2013
Last Update Posted: December 7, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Rouen
April 30, 2013
May 8, 2013
December 7, 2016
May 2013
November 2018   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01849549 on ClinicalTrials.gov Archive Site
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Neuropsychological and Brain Medical Imaging Study in Patients With Brain Damage
Anatomical Clinical Correlations. Neuropsychological and Brain Medical Imaging Study in Brain Damaged Subjects.

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.

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Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
  • Cerebrovascular Disorders
  • Brain Lesions
  • Degenerative Diseases
  • Developmental Pathology
  • Behavioral: Neuropsychological testing
    Experimental test about cognitive deficit of interest and standard neuropsychological tests.
  • Other: MRI
    Anatomical, diffusion, and/or functional MRI
  • Experimental: brain damaged subjects
    patients with circumscribed brain injury, selective disorders of cognitive development or degenerative disorders responsible for focal troubles
    • Behavioral: Neuropsychological testing
    • Other: MRI
  • Sham Comparator: healthy volunteers
    healthy controls
    • Behavioral: Neuropsychological testing
    • Other: MRI
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
January 2019
November 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
Contact: Olivier MARTINAUD, Doctor 2 32 88 87 40 ext +33 olivier.martinaud@chu-rouen.fr
2012-A01332-41 ( Other Identifier: Agence Nationale de sécurité du médicament et des produits de Santé )
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University Hospital, Rouen
University Hospital, Rouen
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Principal Investigator: Olivier MARTINAUD, Doctor service de Neurologie
University Hospital, Rouen
December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP