CORAC2: Neuropsychological and Brain Medical Imaging Study in Patients With Brain Damage 2
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 |
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N/A |
Study Design
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
|
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
Inclusion Criteria:
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Age > 17 years
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French language
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Effective contraception for women during the study
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Informed consent
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No alcohol intake the day before the exam
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For patients only, focal cerebral lesion (stroke, malformation, tumor, inflammatory, infectious, traumatic), neonatal pathology, developmental or degenerative disease with cognitive deficit
Exclusion Criteria:
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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
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For patients: vigilance disorders, severe depression or anxiety.
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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 | |
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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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2017-A03062-51
- 2017-A03062-51