Neuropsychological and Brain Medical Imaging Study in Patients With Brain Damage 2
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Caen
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
Age > 17 years
French language
Effective contraception for women during the study
Informed consent
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Neuropsychological testing
BehavioralExperimental test about cognitive deficit of interest and standard neuropsychological tests
Brain Imaging
Other interventionAnatomical, diffusion, and/or functional MRI
Galvanic Vestibular Stimulation (GVS)
Other interventionStimulation versus Sham
Treatment groups
400 Participants
are divided into 2 treatment groupsGroup A: Brain Damaged SubjectsExperimental treatment 3 interventions
Group B: Healthy VolunteersSham comparator 3 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
3 months to more than 2 yearsSponsors and contacts
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Source ClinicalTrials.gov