Neuropsychological and Brain Medical Imaging Study in Patients With Brain Damage

Cerebrovascular Disorders Clinical Trial

— CORAC  

Official title:

Anatomical Clinical Correlations. Neuropsychological and Brain Medical Imaging Study in Brain Damaged Subjects.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01849549
• Other study ID #: 2012/191/HP
• Secondary ID: 2012-A01332-41
• Status: Recruiting
• Phase: N/A
• First received: April 30, 2013
• Last updated: December 6, 2016
• Start date: May 2013
• Est. completion date: January 2019

Study information

• Verified date: December 2016
• Source: University Hospital, Rouen
• Contact: Olivier MARTINAUD, Doctor
• Phone: 2 32 88 87 40
• Email: olivier.martinaud[@]chu-rouen.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• 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 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) 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: January 2019
• Est. primary completion date: November 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• age between 18 and 80 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 or degenerative disease with cognitive deficit

Exclusion Criteria:

• for healthy volunteers: previous neurological history (except non complicated migraine), previous psychiatric history (except depression with good evolution or anxiety with maximum one anxiolytic treatment), 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, participation in another trial or former involvement in another trial within one month

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Brain Lesions
• Cerebrovascular Disorders
• Degenerative Diseases
• Developmental Pathology

Intervention

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

Other:
• MRI
Anatomical, diffusion, and/or functional MRI

Locations

Country	Name	City	State
France	CHU - Hôpitaux de Rouen	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

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 to 6 months	No