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

Anatomical Clinical Correlations. Neuropsychological and Brain Medical Imaging Study in Brain Damage Subjects 2 (CORAC2)

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.

Study Overview

• Status: Recruiting
• Conditions: Cerebrovascular Disorders; Developmental Disability; Brain Lesion; Degenerative Disease
• Intervention / Treatment: Behavioral: Neuropsychological testing; Other: Brain Imaging; Other: Galvanic Vestibular Stimulation (GVS)

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Olivier MARTINAUD, MD, PhD; Phone Number: +33 2 31 06 46 17; Email: martinaud-o@chu-caen.fr

Study Locations

• France
  • Caen, France, 14000
    • Recruiting
    • CAEN University Hospital
    • Contact: Olivier MARTINAUD, MD, PhD; Phone Number: +33 2 31 06 46 17; Email: martinaud-o@chu-caen.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Brain Damaged Subjects; Patients with circumscribed brain injury, developmental pathology or degenerative pathology responsible for selective cognitive disorders	Behavioral: Neuropsychological testing; Experimental test about cognitive deficit of interest and standard neuropsychological tests; Other: Brain Imaging; Anatomical, diffusion, and/or functional MRI; Other: Galvanic Vestibular Stimulation (GVS); Stimulation versus Sham
Sham Comparator: Healthy Volunteers; Healthy Controls	Behavioral: Neuropsychological testing; Experimental test about cognitive deficit of interest and standard neuropsychological tests; Other: Brain Imaging; Anatomical, diffusion, and/or functional MRI; Other: Galvanic Vestibular Stimulation (GVS); Stimulation versus Sham

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months to more than 2 years

Collaborators and Investigators

• Sponsor: University Hospital, Caen
• Investigators: Principal Investigator: Olivier MARTINAUD, MD, PhD, 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

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2019
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2030

Study Registration Dates

• First Submitted: July 3, 2018
• First Submitted That Met QC Criteria: July 3, 2018
• First Posted (Actual): July 13, 2018

Study Record Updates

• Last Update Posted (Estimated): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 12, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Brain imaging; Neuropsychological study
• Additional Relevant MeSH Terms: Mental Disorders; Cardiovascular Diseases; Vascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Neurodevelopmental Disorders; Brain Injuries; Developmental Disabilities; Cerebrovascular Disorders
• Other Study ID Numbers: 2017-A03062-51 (Other Identifier: ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No