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Active, not recruitingNCT04163315ConnecTCUpdated Dec 3, 2025

Multimodal Connectome Study of Brain Tumor-operated Patients

An interventional study of dMRI, fMRI and electrocorticography in Tumor, Brain, sponsored by Centre Hospitalier Universitaire de Nice. Active, not recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-03.

Sponsored by Centre Hospitalier Universitaire de Nice · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Tumor, Brain

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03

In context

Brain Neoplasms

1,959 studies on the registry are indexed under Brain Neoplasms; 515 are open to participants now.

This study's enrollment of 30 is below the median of 40 across 1,457 interventional studies indexed under Brain Neoplasms.

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Lead sponsor

Centre Hospitalier Universitaire de Nice is the lead sponsor of 709 studies on the registry; 176 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    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.

    Other: dMRI, fMRI and electrocorticography

Interventions

  • OtherdMRI, 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

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What researchers measure

Primary outcomes

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

    Time frame: 1 month

Secondary outcomes

  1. Correlations between neurological disorders, tumor topography and network disruption identified in functional rest MRI

    Time frame: 1 month

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Study locations

1 site
  • CHU de Nice
    Nice, CHU de NICE 06003, France
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References and documents

Publications

  • 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. PubMed 23528922 ↗
  • 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. PubMed 25848923 ↗
  • 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. PubMed 24185018 ↗
  • 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. PubMed 15269116 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04163315
Lead sponsor
Centre Hospitalier Universitaire de Nice
Responsible party
Sponsor
First posted
Nov 14, 2019
Start date
Dec 12, 2019
Primary completion
Jan 12, 2020
Completion
Mar 5, 2026 (estimated)
Last update
Dec 3, 2025

Study contacts

Fabien ALMAIRAC, MD, PhD
principal investigator · Centre Hospitalier Universitaire de Nice

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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