NCT03586258

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
50mo left

Started Jan 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress64%
Jan 2019Jun 2030

First Submitted

Initial submission to the registry

July 3, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 13, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

January 10, 2019

Completed
9.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2030

Last Updated

April 13, 2026

Status Verified

March 1, 2026

Enrollment Period

9.4 years

First QC Date

July 3, 2018

Last Update Submit

April 9, 2026

Conditions

Cerebrovascular DisordersBrain LesionDegenerative DiseaseDevelopmental Disability

Keywords

Neuropsychological studyBrain imaging

Outcome Measures

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.

    3 months to more than 2 years

Study Arms (2)

Brain Damaged Subjects

EXPERIMENTAL

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

Behavioral: Neuropsychological testingOther: Brain ImagingOther: Galvanic Vestibular Stimulation (GVS)

Healthy Volunteers

SHAM COMPARATOR

Healthy Controls

Behavioral: Neuropsychological testingOther: Brain ImagingOther: Galvanic Vestibular Stimulation (GVS)

Interventions

Neuropsychological testingBEHAVIORAL

Experimental test about cognitive deficit of interest and standard neuropsychological tests

Brain Damaged SubjectsHealthy Volunteers
Brain ImagingOTHER

Anatomical, diffusion, and/or functional MRI

Brain Damaged SubjectsHealthy Volunteers
Galvanic Vestibular Stimulation (GVS)OTHER

Stimulation versus Sham

Brain Damaged SubjectsHealthy Volunteers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Caen University Hospital

Caen, 14000, France

RECRUITING

MeSH Terms

Conditions

Cerebrovascular DisordersDevelopmental Disabilities

Interventions

Neuropsychological TestsNeuroimaging

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Psychological TestsBehavioral Disciplines and ActivitiesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, NeurologicalInvestigative Techniques

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Olivier MARTINAUD, MD, PhD

CONTACT

2 31 06 46 17martinaud-o@chu-caen.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2018

First Posted

July 13, 2018

Study Start

January 10, 2019

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2030

Last Updated

April 13, 2026

Record last verified: 2026-03

Locations

FR(1)