Multimodal Connectome Study of Brain Tumor-operated Patients

Tumor, Brain Clinical Trial

— ConnecTC  

Official title:

Multimodal Connectome Study of Brain Tumor-operated Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04163315
• Other study ID #: 19-AOIP-01
• Status: Recruiting
• Phase: N/A
• Start date: December 12, 2019
• Est. completion date: September 2024

Study information

• Verified date: January 2024
• Source: Centre Hospitalier Universitaire de Nice
• Contact: Fabien ALMAIRAC, MD, PhD
• Phone: 04 92 03 85 57
• Email: almairac.f[@]chu-nice.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 2024
• Est. primary completion date: January 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Neoplasms
• Tumor, Brain

Intervention

Other:
• 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

Locations

Country	Name	City	State
France	CHU de Nice	Nice	Chu de Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlations between tumor topography, cortical electrical conduction rates measured in electrocorticography, and microstructural measurements of white substance from diffusion MRI		1 month
Secondary	Correlations between neurological disorders, tumor topography and network disruption identified in functional rest MRI		1 month