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Clinical Trials in France / NCT03586258
Recruiting Not applicable

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

NCT03586258 · tracked via the Priya Life Science France tracker
Sponsor
University Hospital, Caen
Phase
Not applicable
Started
2019-01-10
Last updated
2026-04-13

Condition(s) studied

Cerebrovascular DisordersBrain LesionDegenerative DiseaseDevelopmental Disability

Investigational drug(s) / intervention(s)

Neuropsychological testingBrain ImagingGalvanic Vestibular Stimulation (GVS)

Neuropsychological testing: Experimental test about cognitive deficit of interest and standard neuropsychological tests

Brain Imaging: Anatomical, diffusion, and/or functional MRI

Galvanic Vestibular Stimulation (GVS): Stimulation versus Sham

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • 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.

Trial sites (1)

FacilityCityRegionStatus
Caen University Hospital Caen France Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03586258 on ClinicalTrials.gov ↗ ← All trials in France