Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2016 by University Hospital, Rouen
Information provided by (Responsible Party):
University Hospital, Rouen Identifier:
First received: April 30, 2013
Last updated: December 6, 2016
Last verified: December 2016

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 Intervention
Cerebrovascular Disorders
Brain Lesions
Degenerative Diseases
Developmental Pathology
Behavioral: Neuropsychological testing
Other: MRI

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Anatomical Clinical Correlations. Neuropsychological and Brain Medical Imaging Study in Brain Damaged Subjects.

Resource links provided by NLM:

Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:
  • 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.

Estimated Enrollment: 400
Study Start Date: May 2013
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: November 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01849549

Contact: Olivier MARTINAUD, Doctor 2 32 88 87 40 ext +33

CHU - Hôpitaux de Rouen Recruiting
Rouen, France, 76031
Principal Investigator: Olivier MARTINAUD, Doctor         
Sponsors and Collaborators
University Hospital, Rouen
Principal Investigator: Olivier MARTINAUD, Doctor service de Neurologie
  More Information

Responsible Party: University Hospital, Rouen 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 )
Study First Received: April 30, 2013
Last Updated: December 6, 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 processed this record on May 25, 2017