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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01849549
Recruitment Status : Unknown
Verified December 2016 by University Hospital, Rouen.
Recruitment status was:  Recruiting
First Posted : May 8, 2013
Last Update Posted : December 7, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen

Tracking Information
First Submitted Date  ICMJE April 30, 2013
First Posted Date  ICMJE May 8, 2013
Last Update Posted Date December 7, 2016
Study Start Date  ICMJE May 2013
Estimated Primary Completion Date November 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 7, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Neuropsychological and Brain Medical Imaging Study in Patients With Brain Damage
Official Title  ICMJE Anatomical Clinical Correlations. Neuropsychological and Brain Medical Imaging Study in Brain Damaged Subjects.
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Cerebrovascular Disorders
  • Brain Lesions
  • Degenerative Diseases
  • Developmental Pathology
Intervention  ICMJE
  • Behavioral: Neuropsychological testing
    Experimental test about cognitive deficit of interest and standard neuropsychological tests.
  • Other: MRI
    Anatomical, diffusion, and/or functional MRI
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 29, 2015)
400
Original Estimated Enrollment  ICMJE
 (submitted: May 7, 2013)
280
Estimated Study Completion Date  ICMJE January 2019
Estimated Primary Completion Date November 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01849549
Other Study ID Numbers  ICMJE 2012/191/HP
2012-A01332-41 ( Other Identifier: Agence Nationale de sécurité du médicament et des produits de Santé )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Rouen
Study Sponsor  ICMJE University Hospital, Rouen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Olivier MARTINAUD, Doctor service de Neurologie
PRS Account University Hospital, Rouen
Verification Date December 2016

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