Cerebrovascular DisordersCORAC2NCT03586258
Neuropsychological and Brain Medical Imaging Study in Patients With Brain Damage 2
A study testing Neuropsychological testing, Brain Imaging and Galvanic Vestibular Stimulation (GVS) in people with Cerebrovascular Disorders and Brain Lesion, run by University Hospital, Caen at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cerebrovascular Disorders, Brain Lesion, Degenerative Disease
- What is being tested?
- Neuropsychological testing, Brain Imaging and Galvanic Vestibular Stimulation (GVS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- 10 Jan 2019to Jun 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Caen University Hospital
Caen, 14000
Olivier MARTINAUD, MD, PhD, 2 31 06 46 17 ext. +33, martinaud-o@chu-caen.fr
About this study
Official title: 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.
- Being tested
- Neuropsychological testing, Brain Imaging, Galvanic Vestibular Stimulation (GVS)
- Keywords
- Neuropsychological study, Brain imaging
- Medical subject headings
- Cerebrovascular Disorders, Developmental Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropsychological testingBehavioural
Experimental test about cognitive deficit of interest and standard neuropsychological tests
Brain ImagingOther
Anatomical, diffusion, and/or functional MRI
Galvanic Vestibular Stimulation (GVS)Other
Stimulation versus Sham
| Study group | Role | What they receive |
|---|---|---|
| Brain Damaged Subjects | Experimental | Patients with circumscribed brain injury, developmental pathology or degenerative pathology responsible for selective cognitive disorders Receives: Behavioral: Neuropsychological testing; Other: Brain Imaging; Other: Galvanic Vestibular Stimulation (GVS) |
| Healthy Volunteers | Sham comparator | Healthy Controls Receives: Behavioral: Neuropsychological testing; Other: Brain Imaging; Other: Galvanic Vestibular Stimulation (GVS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months to more than 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2018
- Study start10 Jan 2019
- Primary completionJun 2028 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrovascular DisordersStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier MARTINAUD, MD, PhD, Principal investigator, 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03586258
- Sponsor's protocol ID
- 2017-A03062-51
- Other IDs
- 2017-A03062-51
- Acronym
- CORAC2
- Status last verified
- Mar 2026
- First submitted
- 3 Jul 2018
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anatomical Clinical Correlations. Neuropsychological and Brain Medical Imaging Study in Brain Damage Subjects 2 (CORAC2)
- ClinicalTrials.gov ID
- NCT03586258
- Acronym / sponsor ID
- CORAC2 / 2017-A03062-51
- Keywords
- Neuropsychological study, Brain imaging
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 10 Jan 2019 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 13 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brain Damaged Subjects | Experimental | Behavioral: Neuropsychological testing, Other: Brain Imaging, Other: Galvanic Vestibular Stimulation (GVS)Patients with circumscribed brain injury, developmental pathology or degenerative pathology responsible for selective cognitive disorders |
| Healthy Volunteers | Sham comparator | Behavioral: Neuropsychological testing, Other: Brain Imaging, Other: Galvanic Vestibular Stimulation (GVS)Healthy Controls |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age > 17 years
- French language
- Effective contraception for women during the study
- Informed consent
- No alcohol intake the day before the exam
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuropsychological testingExperimental test about cognitive deficit of interest and standard neuropsychological tests | Behavioural | Brain Damaged Subjects, Healthy Volunteers |
| Brain ImagingAnatomical, diffusion, and/or functional MRI | Other | Brain Damaged Subjects, Healthy Volunteers |
| Galvanic Vestibular Stimulation (GVS)Stimulation versus Sham | Other | Brain Damaged Subjects, Healthy Volunteers |
Primary outcome
Cognitive Deficit
Time frame: 3 months to more than 2 years
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Olivier MARTINAUD, MD, PhD principal investigator
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuropsychological testing, Brain Imaging and Galvanic Vestibular Stimulation (GVS) in people with Cerebrovascular Disorders and Brain Lesion, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Olivier MARTINAUD, MD, PhD (2 31 06 46 17 ext. +33, martinaud-o@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive Deficit (time frame: 3 months to more than 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.