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

Cerebrovascular Disorders Clinical Trial

— CORAC2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03586258
• Other study ID #: 2017-A03062-51
• Secondary ID: 2017-A03062-51
• Status: Recruiting
• Phase: N/A
• Start date: January 10, 2019
• Est. completion date: June 2030

Study information

• Verified date: January 2024
• Source: University Hospital, Caen
• Contact: Olivier MARTINAUD, MD, PhD
• Phone: 2 31 06 46 17
• Email: martinaud-o[@]chu-caen.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: June 2030
• Est. primary completion date: June 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Injuries
• Brain Lesion
• Cerebrovascular Disorders
• Degenerative Disease
• Developmental Disabilities
• Developmental Disability

Intervention

Behavioral:
• Neuropsychological testing
Experimental test about cognitive deficit of interest and standard neuropsychological tests

Other:
• Brain Imaging
Anatomical, diffusion, and/or functional MRI
• Galvanic Vestibular Stimulation (GVS)
Stimulation versus Sham

Locations

Country	Name	City	State
France	Caen University Hospital	Caen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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