CORAC2: Neuropsychological and Brain Medical Imaging Study in Patients With Brain Damage 2

Sponsor

University Hospital, Caen (Other)

Overall Status

Recruiting

CT.gov ID

NCT03586258

Collaborator

(none)

400

Enrollment

Location

Arms

64.7

Anticipated Duration (Months)

6.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cerebrovascular Disorders Brain Lesion Degenerative Disease Developmental Disability	Behavioral: Neuropsychological testing Other: Brain Imaging Other: Galvanic Vestibular Stimulation (GVS)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

400 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Anatomical Clinical Correlations. Neuropsychological and Brain Medical Imaging Study in Brain Damage Subjects 2 (CORAC2)

Actual Study Start Date :

Jan 10, 2019

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Brain Damaged Subjects Patients with circumscribed brain injury, developmental pathology or degenerative pathology responsible for selective cognitive disorders	Behavioral: Neuropsychological testing Experimental test about cognitive deficit of interest and standard neuropsychological tests Other: Brain Imaging Anatomical, diffusion, and/or functional MRI Other: Galvanic Vestibular Stimulation (GVS) Stimulation versus Sham
Sham Comparator: Healthy Volunteers Healthy Controls	Behavioral: Neuropsychological testing Experimental test about cognitive deficit of interest and standard neuropsychological tests Other: Brain Imaging Anatomical, diffusion, and/or functional MRI Other: Galvanic Vestibular Stimulation (GVS) Stimulation versus Sham

Arm

Intervention/Treatment

Experimental: Brain Damaged Subjects

Patients with circumscribed brain injury, developmental pathology or degenerative pathology responsible for selective cognitive disorders

Behavioral: Neuropsychological testing

Experimental test about cognitive deficit of interest and standard neuropsychological tests

Other: Brain Imaging

Anatomical, diffusion, and/or functional MRI

Other: Galvanic Vestibular Stimulation (GVS)

Stimulation versus Sham

Sham Comparator: Healthy Volunteers

Healthy Controls

Behavioral: Neuropsychological testing

Experimental test about cognitive deficit of interest and standard neuropsychological tests

Other: Brain Imaging

Anatomical, diffusion, and/or functional MRI

Other: Galvanic Vestibular Stimulation (GVS)

Stimulation versus Sham

Outcome Measures

Primary Outcome Measures

Cognitive Deficit [3 months to more than 2 years]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Caen University Hospital	Caen		France	14000

Sponsors and Collaborators

University Hospital, Caen

Investigators

Principal Investigator: Olivier MARTINAUD, MD, PhD, 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