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NCT Number: NCT03586258

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

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.

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Key information

Conditions

Cerebrovascular Disorders Brain Diseases Brain Lesion Cardiovascular Diseases Central Nervous System Diseases Degenerative Disease Developmental Disabilities Developmental Disability Mental Disorders Nervous System Diseases Neurodevelopmental Disorders Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Caen University Hospital

Caen, 14000, France

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

neuropsychological testing

Behavioral

Experimental test about cognitive deficit of interest and standard neuropsychological tests

Brain Imaging

Other

Anatomical, diffusion, and/or functional MRI

Galvanic Vestibular Stimulation (GVS)

Other

Stimulation versus Sham

Primary outcomes

  1. 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.

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Official study title

Anatomical Clinical Correlations. Neuropsychological and Brain Medical Imaging Study in Brain Damage Subjects 2 (CORAC2)

Acronym: CORAC2

Important dates

Study start
2019
Primary completion
2028
Study completion
2030
First posted
Jul 13, 2018
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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