Neuropsychological and brain imaging evaluation in patients with brain damage
Anatomical Clinical Correlations. Neuropsychological and Brain Medical Imaging Study in Brain Damage Subjects 2 (CORAC2)
This study tests how brain injuries affect thinking and memory by comparing patients with brain damage to healthy people using brain scans and other tests.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Caen Academic / other |
| Locations | 1 site (Caen) |
| Trial ID | NCT03586258 on ClinicalTrials.gov |
What this trial studies
This study involves two groups: patients with specific brain injuries or cognitive disorders and healthy control subjects. It aims to assess neuropsychological deficits and utilize advanced brain imaging techniques, such as anatomical and functional imaging, to understand the brain mechanisms behind these deficits. The interventions include neuropsychological testing, brain imaging, and galvanic vestibular stimulation. The goal is to provide insights into how brain damage affects cognitive functions.
Who should consider this trial
Good fit: Ideal candidates include individuals over 17 years old with focal cerebral lesions or cognitive deficits due to degenerative or developmental disorders.
Not a fit: Patients with severe depression, anxiety, or vigilance disorders, as well as those on psychotropic medications, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and treatment options for patients with cognitive deficits due to brain damage.
How similar studies have performed: Other studies utilizing neuropsychological assessments and brain imaging have shown promise in understanding cognitive deficits, suggesting this approach is supported by prior research.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Caen
- Caen University Hospital — Caen, France (Recruiting)
Study contacts
- 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 coordinator: Olivier MARTINAUD, MD, PhD
- Email: martinaud-o@chu-caen.fr
- Phone: 2 31 06 46 17
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.