Bridging Brain Structure and Function by Correlating Structural Connectivity, Cortico-Cortical Transmission and Direct Electro-Stimulation
Primary Purpose
Tumor, Brain
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
electrocorticography with electrostimulation
dRMI
Sponsored by
About this trial
This is an interventional other trial for Tumor, Brain
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
dMRI and electrocorticography
Arm Description
Direct measurements of cortical electrical properties of patients operated on awake surgery for a brain tumor, using electrocorticography (ECoG), based on the dMRI tractography data previously acquired for each patient.
Outcomes
Primary Outcome Measures
Descriptive activity of brain with dMRI results
Descriptive functional responses elicited by the direct electrostimulation of the cortex.
Secondary Outcome Measures
Full Information
NCT ID
NCT03503110
First Posted
March 20, 2018
Last Updated
April 19, 2018
Sponsor
Centre Hospitalier Universitaire de Nice
Collaborators
Institut National de Recherche en Informatique et en Automatique
1. Study Identification
Unique Protocol Identification Number
NCT03503110
Brief Title
Bridging Brain Structure and Function by Correlating Structural Connectivity, Cortico-Cortical Transmission and Direct Electro-Stimulation
Official Title
Anatomo-functional Study of the Brain Cortical and Sub-cortical Connectivity Using Diffusion MRI, Electrocorticography and Direct Electrical Stimulation
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 2018 (Anticipated)
Primary Completion Date
July 2019 (Anticipated)
Study Completion Date
July 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice
Collaborators
Institut National de Recherche en Informatique et en Automatique
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tumor, Brain
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
dMRI and electrocorticography
Arm Type
Experimental
Arm Description
Direct measurements of cortical electrical properties of patients operated on awake surgery for a brain tumor, using electrocorticography (ECoG), based on the dMRI tractography data previously acquired for each patient.
Intervention Type
Other
Intervention Name(s)
electrocorticography with electrostimulation
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
dRMI
Intervention Description
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)
Primary Outcome Measure Information:
Title
Descriptive activity of brain with dMRI results
Time Frame
after the operation (1 month)
Title
Descriptive functional responses elicited by the direct electrostimulation of the cortex.
Time Frame
after the operation (1 month)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fabien ALMAIRAC, MD, PhD
Phone
04 92 03 85 57
Email
almairac.f@chu-nice.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabien ALMAIRAC, MD, PhD
Organizational Affiliation
Centre Hospitalier Universitaire de Nice
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
23528922
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.
Results Reference
result
PubMed Identifier
25848923
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.
Results Reference
result
PubMed Identifier
24615889
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. 2014 Sep;35(9):4345-61. doi: 10.1002/hbm.22479. Epub 2014 Feb 24.
Results Reference
result
PubMed Identifier
12704393
Citation
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.
Results Reference
result
PubMed Identifier
20121442
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 craniotomy: methodological aspects of current practice. Neurosurg Focus. 2010 Feb;28(2):E7. doi: 10.3171/2009.12.FOCUS09237.
Results Reference
result
PubMed Identifier
19747052
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: 10.3171/2009.8.JNS09558.
Results Reference
result
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Bridging Brain Structure and Function by Correlating Structural Connectivity, Cortico-Cortical Transmission and Direct Electro-Stimulation
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