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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-10

Study Completion Date

2030-06-30

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.

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Detailed Description

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Conditions

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Cerebrovascular Disorders Brain Lesion Degenerative Disease Developmental Disability

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Brain Damaged Subjects

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

Group Type EXPERIMENTAL

Neuropsychological testing

Intervention Type BEHAVIORAL

Experimental test about cognitive deficit of interest and standard neuropsychological tests

Brain Imaging

Intervention Type OTHER

Anatomical, diffusion, and/or functional MRI

Galvanic Vestibular Stimulation (GVS)

Intervention Type OTHER

Stimulation versus Sham

Healthy Volunteers

Healthy Controls

Group Type SHAM_COMPARATOR

Neuropsychological testing

Intervention Type BEHAVIORAL

Experimental test about cognitive deficit of interest and standard neuropsychological tests

Brain Imaging

Intervention Type OTHER

Anatomical, diffusion, and/or functional MRI

Galvanic Vestibular Stimulation (GVS)

Intervention Type OTHER

Stimulation versus Sham

Interventions

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Neuropsychological testing

Experimental test about cognitive deficit of interest and standard neuropsychological tests

Intervention Type BEHAVIORAL

Brain Imaging

Anatomical, diffusion, and/or functional MRI

Intervention Type OTHER

Galvanic Vestibular Stimulation (GVS)

Stimulation versus Sham

Intervention Type OTHER

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Olivier MARTINAUD, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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