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RecruitingNCT03586258CORAC2Updated Apr 13, 2026

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

An interventional study of Neuropsychological testing and Brain Imaging in Cerebrovascular Disorders, Brain Lesion and Degenerative Disease, sponsored by University Hospital, Caen. Recruiting at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-13.

Sponsored by University Hospital, Caen · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Started Jan 2019; still recruiting 7 years 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
400
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

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

Keywords

  • Neuropsychological study
  • Brain imaging
03

In context

Cerebrovascular Disorders

449 studies on the registry are indexed under Cerebrovascular Disorders; 127 are open to participants now.

This study's planned enrollment of 400 is above the median of 100 across 274 interventional studies indexed under Cerebrovascular Disorders.

Browse Cerebrovascular Disorders studies →

Lead sponsor

University Hospital, Caen is the lead sponsor of 512 studies on the registry; 82 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age > 17 years
  • French language
  • Effective for women during the study
  • 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

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, for MRI or GVS if applicable, participation in another trial or former involvement in another trial within one month.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
400 participants (estimated)

Study arms

  • Experimental
    Brain Damaged Subjects

    Patients with circumscribed brain injury, developmental pathology or degenerative pathology responsible for selective cognitive disorders

    Behavioral: Neuropsychological testing · Other: Brain Imaging · Other: Galvanic Vestibular Stimulation (GVS)

  • Sham comparator
    Healthy Volunteers

    Healthy Controls

    Behavioral: Neuropsychological testing · Other: Brain Imaging · Other: Galvanic Vestibular Stimulation (GVS)

Interventions

  • BehavioralNeuropsychological testing

    Experimental test about cognitive deficit of interest and standard neuropsychological tests

  • OtherBrain Imaging

    Anatomical, diffusion, and/or functional MRI

  • OtherGalvanic Vestibular Stimulation (GVS)

    Stimulation versus Sham

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 months to more than 2 years

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03586258
Responsible party
Sponsor
First posted
Jul 13, 2018
Start date
Jan 10, 2019
Primary completion
Jun 2028 (estimated)
Completion
Jun 2030 (estimated)
Last update
Apr 13, 2026

Study contacts

Olivier MARTINAUD, MD, PhD
Contact
martinaud-o@chu-caen.fr
2 31 06 46 17 ext. +33
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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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