Neuropsychological and Brain Medical Imaging Study in Patients With Brain Damage 2 (CORAC2)

Caen University Hospital

Status: Enrolling

Conditions: Degenerative Disease; Developmental Disability; Cerebrovascular Disorders; Brain Lesion

Treatments: Other: Galvanic Vestibular Stimulation (GVS); Other: Brain Imaging; Behavioral: Neuropsychological testing

Study type: Interventional

Funder types: Other

Identifiers

NCT03586258

2017-A03062-51 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

Brain Damaged Subjects

Experimental group

Description:

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

Treatment:

Behavioral: Neuropsychological testing

Other: Galvanic Vestibular Stimulation (GVS)

Other: Brain Imaging

Healthy Volunteers

Sham Comparator group

Description:

Healthy Controls

Treatment:

Behavioral: Neuropsychological testing

Other: Galvanic Vestibular Stimulation (GVS)

Other: Brain Imaging