Clinical trial NCT04163315: Multimodal Connectome Study of Brain Tumor-operated Patients
Official title: Multimodal Connectome Study of Brain Tumor-operated Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tumor, Brain
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2019-11-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Correlations between tumor topography, cortical electrical conduction rates measured in electrocorticography, and microstructural measurements of white substance from diffusion MRI
timeFrame: 1 month
Secondary outcomes:
measure: Correlations between neurological disorders, tumor topography and network disruption identified in functional rest MRI
timeFrame: 1 month
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice
state: Chu de Nice
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: Fabien ALMAIRAC, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.