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

Study Overview
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Brief Summary
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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.

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

Conditions
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Cerebrovascular Disorders, Brain Lesion, Degenerative Disease, Developmental Disability

Intervention / Treatment
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* Behavioral: Neuropsychological testing
* Other: Brain Imaging
* Other: Galvanic Vestibular Stimulation (GVS)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 months to more than 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neuropsychological study, Brain imaging