Neuropsychological and Brain Medical Imaging Study in Patients With Brain Damage 2 (CORAC2)
Primary Purpose
Cerebrovascular Disorders, Brain Lesion, Degenerative Disease
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Neuropsychological testing
Brain Imaging
Galvanic Vestibular Stimulation (GVS)
Sponsored by
About this trial
This is an interventional diagnostic trial for Cerebrovascular Disorders focused on measuring Neuropsychological study, Brain imaging
Eligibility Criteria
Inclusion Criteria:
- Age > 17 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, developmental or degenerative disease with cognitive deficit
Exclusion Criteria:
- For healthy volunteers: previous neurological history (except non complicated migraine or epilepsy), previous psychiatric history (except depression with good evolution or anxiety), 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 or GVS if applicable, participation in another trial or former involvement in another trial within one month.
Sites / Locations
- Caen University HospitalRecruiting
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, developmental pathology or degenerative pathology responsible for selective cognitive disorders
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
NCT ID
NCT03586258
First Posted
July 3, 2018
Last Updated
August 29, 2023
Sponsor
University Hospital, Caen
1. Study Identification
Unique Protocol Identification Number
NCT03586258
Brief Title
Neuropsychological and Brain Medical Imaging Study in Patients With Brain Damage 2
Acronym
CORAC2
Official Title
Anatomical Clinical Correlations. Neuropsychological and Brain Medical Imaging Study in Brain Damage Subjects 2 (CORAC2)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 10, 2019 (Actual)
Primary Completion Date
June 2028 (Anticipated)
Study Completion Date
June 2030 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
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/developmental 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, magnetic stimulation) 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 Lesion, Degenerative Disease, Developmental Disability
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, developmental pathology or degenerative pathology responsible for selective cognitive disorders
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)
Brain Imaging
Intervention Description
Anatomical, diffusion, and/or functional MRI
Intervention Type
Other
Intervention Name(s)
Galvanic Vestibular Stimulation (GVS)
Intervention Description
Stimulation versus Sham
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 months to more than 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age > 17 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, developmental or degenerative disease with cognitive deficit
Exclusion Criteria:
For healthy volunteers: previous neurological history (except non complicated migraine or epilepsy), previous psychiatric history (except depression with good evolution or anxiety), 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 or GVS if applicable, 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, MD, PhD
Phone
2 31 06 46 17
Ext
+33
Email
martinaud-o@chu-caen.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier MARTINAUD, MD, PhD
Organizational Affiliation
Caen University Hospital, Normandie UNIV, UNICAEN, PSL Research University, EPHE, Inserm, U1077, CHU de Caen, Neuropsychologie et Imagerie de la Mémoire Humaine, 14000 Caen, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Caen University Hospital
City
Caen
ZIP/Postal Code
14000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier MARTINAUD, MD, PhD
Phone
2 31 06 46 17
Ext
+33
Email
martinaud-o@chu-caen.fr
12. IPD Sharing Statement
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Neuropsychological and Brain Medical Imaging Study in Patients With Brain Damage 2
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