Bridging Brain Structure and Function by Correlating Structural Connectivity, Cortico-Cortical Transmission and Direct Electro-Stimulation

Tumor, Brain Clinical Trial

Official title:

Anatomo-functional Study of the Brain Cortical and Sub-cortical Connectivity Using Diffusion MRI, Electrocorticography and Direct Electrical Stimulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03503110
• Other study ID #: 17-PP-15
• Status: Completed
• Phase: N/A
• Start date: April 19, 2018
• Est. completion date: September 9, 2019

Study information

• Verified date: November 2023
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Elucidating the structure-function relationship of the brain is one of the main open questions in neuroscience. The capabilities of diffusion MRI-based (dMRI) techniques to quantify the connectivity strength between brain areas, namely structural connectivity (SC), in combination with modalities such as electroencephalography (EEG) to quantify brain function have enabled advances in this field. However, so far the actual relationship between SC measures and measures of information transport between neuronal patches has not been determined. In this project, we aim to establish a relationship between dMRI SC measures, direct measures of electrical properties of the human brain cortex obtained with electrocorticography (ECoG), and response elicited by direct electrostimulation of the brain (DES). Ten patients operated on awake surgery for brain tumor removal will be included. First, a dMRI will be acquired prior to the surgery, in order to extract SC indices through probabilistic tractography. Then, intrasurgical cortico-cortical electrical measures will be obtained by ECoG electrodes positioned on the predefined cortical terminations of the designated bundles. These measures will be correlated to functional responses obtained during the cortical cartography, following the common DES procedure. The results of this multi-modal approach combining structure and function explorations of the brain should help to elucidate the relationship between non-invasive (dMRI) SC measures and cortico-cortical transmission properties (delays, transfer functions), and should boost the understanding of cognitive function as well as neurosurgical planning for the treatment of pathologies such as brain tumor resection and drug-resistant epilepsy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: September 9, 2019
• Est. primary completion date: September 9, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient eligible at an awake surgery for a brain tumor resection
• Informed consent of the patient

Exclusion Criteria:

• Contraindication to MRI
• Withdrawal of the patient's consent

Related Conditions & MeSH terms

• Brain Neoplasms
• Tumor, Brain

Intervention

Other:
• electrocorticography with electrostimulation
The investigators aim to establish a relationship between dMRI SC measures, direct measures of electrical properties of the human brain cortex obtained with electrocorticography (ECoG), and response elicited by direct electrostimulation of the brain (DES)
• dRMI
The investigators aim to establish a relationship between dMRI SC measures, direct measures of electrical properties of the human brain cortex obtained with electrocorticography (ECoG), and response elicited by direct electrostimulation of the brain (DES)

Locations

Country	Name	City	State
France	CHU NICE	Nice

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice	Institut National de Recherche en Informatique et en Automatique

Country where clinical trial is conducted

France, 

References & Publications (6)

Bates E, Wilson SM, Saygin AP, Dick F, Sereno MI, Knight RT, Dronkers NF. Voxel-based lesion-symptom mapping. Nat Neurosci. 2003 May;6(5):448-50. doi: 10.1038/nn1050. No abstract available. — View 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. — View Citation

Leclercq D, Duffau H, Delmaire C, Capelle L, Gatignol P, Ducros M, Chiras J, Lehericy S. Comparison of diffusion tensor imaging tractography of language tracts and intraoperative subcortical stimulations. J Neurosurg. 2010 Mar;112(3):503-11. doi: 10.3171/ — 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

Szelenyi A, Bello L, Duffau H, Fava E, Feigl GC, Galanda M, Neuloh G, Signorelli F, Sala F; Workgroup for Intraoperative Management in Low-Grade Glioma Surgery within the European Low-Grade Glioma Network. Intraoperative electrical stimulation in awake cr — View Citation

Yamao Y, Matsumoto R, Kunieda T, Arakawa Y, Kobayashi K, Usami K, Shibata S, Kikuchi T, Sawamoto N, Mikuni N, Ikeda A, Fukuyama H, Miyamoto S. Intraoperative dorsal language network mapping by using single-pulse electrical stimulation. Hum Brain Mapp. 201 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Descriptive activity of brain with dMRI results		after the operation (1 month)
Primary	Descriptive functional responses elicited by the direct electrostimulation of the cortex.		after the operation (1 month)