Multimodal Connectome Study of Brain Tumor-operated Patients

NCT ID: NCT04163315

Last Updated: 2025-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-12

Study Completion Date

2026-03-05

Brief Summary

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In this pilot study, the investigators propose a multimodal evaluation of the brain connectivity of brain tumor patients, in order to better understand the effects induced by focal lesions on brain structure and function, as well as brain plasticity mechanisms that may occur in such condition. The investigators aim at drawing a multimodal brain connectivity map of focally brain-damaged patients, with a view to improve onco-functional neurosurgical practices.

Detailed Description

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Patients included in the present study will first perform the pre-operative MRI (dMRI and fMRI) with a specific High Resolution Angular Diffusion (HARDI) sequence and a functional acquisition at rest. Then, the investigators will record their cortico-cortical evoked potentials elicited by direct electrostimulation during the surgery, just before the tumor removal, following our usual protocol. Finally, all data (clinical, diffusion, electrical and functional connectivity) will be processed and correlated to each other.

Conditions

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Tumor, Brain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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dMRI, fMRI and electrocorticography

With this exploratory pilot study, the investigator propose a multimodal evaluation of the structural and functional connectivity of patients with brain tumours, in order to better understand the tumor-induced lesion mechanisms on brain connectivity as well as the brain plasticity mechanisms that the brain develops to maintain a level of overall function neurological. The investigator hope to obtain multimodal brain mapping of locally brain-damaged patients, with a view to improving onco-functional neurosurgical practices.

Group Type EXPERIMENTAL

dMRI, fMRI and electrocorticography

Intervention Type OTHER

Patients included in the study will perform the pre-operative MRI (fMRI and fMRI) with a specific High Resolution Angular Diffusion (HARDI) sequence and a functional rest sequence. The additional scan time for this specific sequence is approximately 25 minutes, with no foreseeable negative impact on the patient

Interventions

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dMRI, fMRI and electrocorticography

Patients included in the study will perform the pre-operative MRI (fMRI and fMRI) with a specific High Resolution Angular Diffusion (HARDI) sequence and a functional rest sequence. The additional scan time for this specific sequence is approximately 25 minutes, with no foreseeable negative impact on the patient

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* All patients with brain tumor for removal
* Age \> 18 years
* Informed patient consent
* Membership of social security scheme

Exclusion Criteria

* Contraindication to MRI
* Any subject with vascular stent implanted less than 6 weeks prior to the exam;
* Any subject carrying an intraocular or intracranial ferromagnetic foreign object close to nerve structures;
* Any subject carrying biomedical equipment such as a cardiac, neuronal or sensory pacemaker (cochlear implant) or a ventricular bypass valve without medical and paramedical supervision trained in the performance of MRI in these subjects;
* Presence of more than one brain tumor
* Refusal of patient participation
* Pregnant or nursing women. A urinary pregnancy test will be conducted for women of childbearing age. The results will be communicated to the patient by a doctor of her choice.
* Person staying in a health or social establishment
* Person in emergency situation
* Vulnerable patient: deprived of liberty, guardianship, curators, or safeguarding of justice
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fabien ALMAIRAC, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nice

Locations

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CHU de Nice

Nice, CHU de NICE, France

Site Status

Countries

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France

References

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Sporns O. The human connectome: origins and challenges. Neuroimage. 2013 Oct 15;80:53-61. doi: 10.1016/j.neuroimage.2013.03.023. Epub 2013 Mar 23.

Reference Type BACKGROUND
PMID: 23528922 (View on PubMed)

Duffau H. Stimulation mapping of white matter tracts to study brain functional connectivity. Nat Rev Neurol. 2015 May;11(5):255-65. doi: 10.1038/nrneurol.2015.51. Epub 2015 Apr 7.

Reference Type BACKGROUND
PMID: 25848923 (View on PubMed)

Yeo BT, Krienen FM, Chee MW, Buckner RL. Estimates of segregation and overlap of functional connectivity networks in the human cerebral cortex. Neuroimage. 2014 Mar;88:212-27. doi: 10.1016/j.neuroimage.2013.10.046. Epub 2013 Nov 1.

Reference Type BACKGROUND
PMID: 24185018 (View on PubMed)

Matsumoto R, Nair DR, LaPresto E, Najm I, Bingaman W, Shibasaki H, Luders HO. Functional connectivity in the human language system: a cortico-cortical evoked potential study. Brain. 2004 Oct;127(Pt 10):2316-30. doi: 10.1093/brain/awh246. Epub 2004 Jul 21.

Reference Type BACKGROUND
PMID: 15269116 (View on PubMed)

Other Identifiers

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19-AOIP-01

Identifier Type: -

Identifier Source: org_study_id

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