Multimodal Connectome Study of Brain Tumor-operated Patients

Not Applicable

Recruiting

• Conditions: Tumor, Brain
• Interventions: Other: dMRI, fMRI and electrocorticography

• Registration Number: NCT04163315
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-11-12
• Study First Submitted QC: 2019-11-13
• Study First Posted: 2019-11-14
• Study Start: 2019-12-12
• Primary Completion: 2020-01-12
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-11
• Last Update Posted: 2024-01-12
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
dMRI, fMRI and electrocorticography	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.

Primary Outcome Measures

Name	Time	Method
Correlations between tumor topography, cortical electrical conduction rates measured in electrocorticography, and microstructural measurements of white substance from diffusion MRI	1 month

Secondary Outcome Measures

Name	Time	Method
Correlations between neurological disorders, tumor topography and network disruption identified in functional rest MRI	1 month

Trial Locations

Locations (1)

CHU de Nice; 🇫🇷 Nice, Chu de Nice, France