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

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ClinicalTrials.gov Identifier: NCT03503110
Recruitment Status : Not yet recruiting
First Posted : April 19, 2018
Last Update Posted : April 20, 2018
Sponsor:
Collaborator:
Institut National de Recherche en Informatique et en Automatique
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

Study Description
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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.

Condition or disease Intervention/treatment Phase
Tumor, Brain Other: electrocorticography with electrostimulation Other: dRMI Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Anatomo-functional Study of the Brain Cortical and Sub-cortical Connectivity Using Diffusion MRI, Electrocorticography and Direct Electrical Stimulation
Estimated Study Start Date : April 2018
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019
Arms and Interventions
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Arm Intervention/treatment
Experimental: dMRI and electrocorticography
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.
 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)

Other: 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)


Outcome Measures
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Primary Outcome Measures :
  1. Descriptive activity of brain with dMRI results [ Time Frame: after the operation (1 month) ]
  2. Descriptive functional responses elicited by the direct electrostimulation of the cortex. [ Time Frame: after the operation (1 month) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03503110


Contacts
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Contact: Fabien ALMAIRAC, MD, PhD 04 92 03 85 57 almairac.f@chu-nice.fr

Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Institut National de Recherche en Informatique et en Automatique
Investigators
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Principal Investigator: Fabien ALMAIRAC, MD, PhD Centre Hospitalier Universitaire de Nice
More Information
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Publications of Results:

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Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT03503110     History of Changes
Other Study ID Numbers: 17-PP-15
First Posted: April 19, 2018    Key Record Dates
Last Update Posted: April 20, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
 Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases