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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
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Tumor, Brain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    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
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    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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