Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE March 20, 2018
First Posted Date  ICMJE April 19, 2018
Last Update Posted Date April 20, 2018
Estimated Study Start Date  ICMJE April 2018
Estimated Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 19, 2018)
  • Descriptive activity of brain with dMRI results [ Time Frame: after the operation (1 month) ]
  • Descriptive functional responses elicited by the direct electrostimulation of the cortex. [ Time Frame: after the operation (1 month) ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 11, 2018)
  • Descriptive activity of brain with dMRI results [ Time Frame: after the operation (1 month) ]
    Relationship between dMRI structural connectivity measures, cortico-cortical evoked potentials measures, and functional responses elicited by the direct electrostimulation of the cortex.
  • Descriptive functional responses elicited by the direct electrostimulation of the cortex. [ Time Frame: after the operation (1 month) ]
Change History Complete list of historical versions of study NCT03503110 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bridging Brain Structure and Function by Correlating Structural Connectivity, Cortico-Cortical Transmission and Direct Electro-Stimulation
Official Title  ICMJE Anatomo-functional Study of the Brain Cortical and Sub-cortical Connectivity Using Diffusion MRI, Electrocorticography and Direct Electrical Stimulation
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Tumor, Brain
Intervention  ICMJE
  • 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)
Study Arms  ICMJE 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.
Interventions:
  • Other: electrocorticography with electrostimulation
  • Other: dRMI
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 11, 2018)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2019
Estimated Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Fabien ALMAIRAC, MD, PhD 04 92 03 85 57 almairac.f@chu-nice.fr
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03503110
Other Study ID Numbers  ICMJE 17-PP-15
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Centre Hospitalier Universitaire de Nice
Study Sponsor  ICMJE Centre Hospitalier Universitaire de Nice
Collaborators  ICMJE Institut National de Recherche en Informatique et en Automatique
Investigators  ICMJE
Principal Investigator: Fabien ALMAIRAC, MD, PhD Centre Hospitalier Universitaire de Nice
PRS Account Centre Hospitalier Universitaire de Nice
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP