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

Primary Purpose

Cerebrovascular Disorders, Brain Lesions, Degenerative Diseases

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Neuropsychological testing
MRI
Sponsored by
University Hospital, Rouen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cerebrovascular Disorders focused on measuring neuropsychological Study, brain Imaging

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CHU - Hôpitaux de RouenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

brain damaged subjects

healthy volunteers

Arm Description

patients with circumscribed brain injury, selective disorders of cognitive development or degenerative disorders responsible for focal troubles

healthy controls

Outcomes

Primary Outcome Measures

Cognitive deficit
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.

Secondary Outcome Measures

Full Information

First Posted
April 30, 2013
Last Updated
December 6, 2016
Sponsor
University Hospital, Rouen
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1. Study Identification

Unique Protocol Identification Number
NCT01849549
Brief Title
Neuropsychological and Brain Medical Imaging Study in Patients With Brain Damage
Acronym
CORAC
Official Title
Anatomical Clinical Correlations. Neuropsychological and Brain Medical Imaging Study in Brain Damaged Subjects.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2013 (undefined)
Primary Completion Date
November 2018 (Anticipated)
Study Completion Date
January 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Disorders, Brain Lesions, Degenerative Diseases, Developmental Pathology
Keywords
neuropsychological Study, brain Imaging

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
brain damaged subjects
Arm Type
Experimental
Arm Description
patients with circumscribed brain injury, selective disorders of cognitive development or degenerative disorders responsible for focal troubles
Arm Title
healthy volunteers
Arm Type
Sham Comparator
Arm Description
healthy controls
Intervention Type
Behavioral
Intervention Name(s)
Neuropsychological testing
Intervention Description
Experimental test about cognitive deficit of interest and standard neuropsychological tests.
Intervention Type
Other
Intervention Name(s)
MRI
Intervention Description
Anatomical, diffusion, and/or functional MRI
Primary Outcome Measure Information:
Title
Cognitive deficit
Description
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.
Time Frame
3 to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Olivier MARTINAUD, Doctor
Phone
2 32 88 87 40
Ext
+33
Email
olivier.martinaud@chu-rouen.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier MARTINAUD, Doctor
Organizational Affiliation
service de Neurologie
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU - Hôpitaux de Rouen
City
Rouen
ZIP/Postal Code
76031
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier MARTINAUD, Doctor

12. IPD Sharing Statement

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Neuropsychological and Brain Medical Imaging Study in Patients With Brain Damage

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