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

Not Applicable

Recruiting

• Conditions: Degenerative Disease; Cerebrovascular Disorders; Brain Lesion; Developmental Disability
• Interventions: Behavioral: Neuropsychological testing; Other: Brain Imaging; Other: Galvanic Vestibular Stimulation (GVS)

• Registration Number: NCT03586258
• Lead Sponsor: University Hospital, Caen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-03
• Study First Submitted QC: 2018-07-03
• Study First Posted: 2018-07-13
• Study Start: 2019-01-10
• Status Verified: 2024-01
• Last Update Submitted: 2024-02-12
• Last Update Posted: 2024-02-13
• Primary Completion: 2028-06
• Study Completion: 2030-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Brain Damaged Subjects	Neuropsychological testing	Patients with circumscribed brain injury, developmental pathology or degenerative pathology responsible for selective cognitive disorders
Healthy Volunteers	Neuropsychological testing	Healthy Controls
Healthy Volunteers	Brain Imaging	Healthy Controls
Healthy Volunteers	Galvanic Vestibular Stimulation (GVS)	Healthy Controls
Brain Damaged Subjects	Brain Imaging	Patients with circumscribed brain injury, developmental pathology or degenerative pathology responsible for selective cognitive disorders
Brain Damaged Subjects	Galvanic Vestibular Stimulation (GVS)	Patients with circumscribed brain injury, developmental pathology or degenerative pathology responsible for selective cognitive disorders

Primary Outcome Measures

Name	Time	Method
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 Locations

Locations (1)

Caen University Hospital; 🇫🇷 Caen, France