Neuropsychological and Brain Medical Imaging Study in Patients With Brain Damage (CORAC)
This study is currently recruiting participants.
(see Contacts and Locations)
Verified September 2014 by University Hospital, Rouen
Sponsor:
University Hospital, Rouen
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT01849549
First received: April 30, 2013
Last updated: September 1, 2014
Last verified: September 2014
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Cerebrovascular Disorders Brain Lesions Degenerative Diseases Developmental Pathology |
Behavioral: Neuropsychological testing Other: MRI |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Anatomical Clinical Correlations. Neuropsychological and Brain Medical Imaging Study in Brain Damaged Subjects. |
Resource links provided by NLM:
Further study details as provided by University Hospital, Rouen:
Primary Outcome Measures:
- Cognitive deficit [ Time Frame: 3 to 6 months ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 280 |
| Study Start Date: | May 2013 |
| Estimated Study Completion Date: | January 2019 |
| Estimated Primary Completion Date: | November 2018 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: brain damaged subjects
patients with circumscribed brain injury, selective disorders of cognitive development or degenerative disorders responsible for focal troubles
|
Behavioral: Neuropsychological testing
Experimental test about cognitive deficit of interest and standard neuropsychological tests.
Other: MRI
Anatomical, diffusion, and/or functional MRI
|
|
Sham Comparator: healthy volunteers
healthy controls
|
Behavioral: Neuropsychological testing
Experimental test about cognitive deficit of interest and standard neuropsychological tests.
Other: MRI
Anatomical, diffusion, and/or functional MRI
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01849549
Please refer to this study by its ClinicalTrials.gov identifier: NCT01849549
Contacts
| Contact: Olivier MARTINAUD, Doctor | 2 32 88 87 40 ext +33 | olivier.martinaud@chu-rouen.fr |
Locations
| France | |
| CHU - Hôpitaux de Rouen | Recruiting |
| Rouen, France, 76031 | |
| Principal Investigator: Olivier MARTINAUD, Doctor | |
Sponsors and Collaborators
University Hospital, Rouen
Investigators
| Principal Investigator: | Olivier MARTINAUD, Doctor | service de Neurologie |
More Information
No publications provided
| Responsible Party: | University Hospital, Rouen |
| ClinicalTrials.gov Identifier: | NCT01849549 History of Changes |
| Other Study ID Numbers: | 2012/191/HP, 2012-A01332-41 |
| Study First Received: | April 30, 2013 |
| Last Updated: | September 1, 2014 |
| Health Authority: | France: Agence Nationale de Sécurité du Médicament et des produits de santé |
Keywords provided by University Hospital, Rouen:
|
neuropsychological Study brain Imaging |
Additional relevant MeSH terms:
|
Cerebrovascular Disorders Brain Diseases Cardiovascular Diseases |
Central Nervous System Diseases Nervous System Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on February 27, 2015