Neuropsychological and Brain Medical Imaging Study in Patients With Brain Damage 2
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Neuropsychological testing, Brain Imaging, Galvanic Vestibular Stimulation (GVS).
- Who it may be relevant to
- Registry conditions: Cerebrovascular Disorders, Brain Lesion, Degenerative Disease, Developmental Disability. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Anatomical Clinical Correlations. Neuropsychological and Brain Medical Imaging Study in Brain Damage Subjects 2 (CORAC2)
Overview
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.
Interventions
- 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
Primary outcome measures
- Cognitive Deficit [Time frame: 3 months to more than 2 years]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
France · 1 center
- Caen University Hospital — Caen
Identifiers
NCT: NCT03586258 · 2017-A03062-51 · 2017-A03062-51