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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by University Hospital, Rouen
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT01849549
First received: April 30, 2013
Last updated: June 17, 2013
Last verified: June 2013
  Purpose

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
Endpoint Classification: Efficacy Study
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 ] [ 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.


Estimated Enrollment: 280
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 ClinicalTrials.gov identifier: NCT01849549

Contacts
Contact: Olivier MARTINAUD, Doctor 2 32 88 87 40 ext +33 olivier.martinaud@chu-rouen.fr

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

No publications provided

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT01849549     History of Changes
Other Study ID Numbers: 2012/191/HP, 2012-A01332-41
Study First Received: April 30, 2013
Last Updated: June 17, 2013
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

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

ClinicalTrials.gov processed this record on August 20, 2014