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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by University Hospital, Rouen
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT01849549
First received: April 30, 2013
Last updated: September 1, 2014
Last verified: September 2014

April 30, 2013
September 1, 2014
May 2013
November 2018   (final data collection date for primary outcome measure)
Cognitive deficit [ Time Frame: 3 to 6 months ] [ Designated as safety issue: No ]
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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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
    Interventions:
    • Behavioral: Neuropsychological testing
    • Other: MRI
  • Sham Comparator: healthy volunteers
    healthy controls
    Interventions:
    • Behavioral: Neuropsychological testing
    • Other: MRI
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
280
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
Both
18 Years to 80 Years
Yes
Contact: Olivier MARTINAUD, Doctor 2 32 88 87 40 ext +33 olivier.martinaud@chu-rouen.fr
France
 
NCT01849549
2012/191/HP, 2012-A01332-41
No
University Hospital, Rouen
University Hospital, Rouen
Not Provided
Principal Investigator: Olivier MARTINAUD, Doctor service de Neurologie
University Hospital, Rouen
September 2014

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