Cerebral Bases Bodily Representations (EBA)
Primary Purpose
Glial Tumors
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
functional MRI
Sponsored by
About this trial
This is an interventional basic science trial for Glial Tumors
Eligibility Criteria
Inclusion Criteria:
- Age greater than 18 years
- Candidate awake in a long surgery
- Carrying on an original tumor glial parietal or temporal
- Normal global cognitive efficiency score greater than or equal to 27
Exclusion Criteria:
- Patient ambidextrous or left
- Non glial tumor
- Tumor not involving the temporal or parietal lobes
- Consumption of non-drug substance
- Visual perceptual disorder and or space
- Global Cognitive Impairment
Sites / Locations
- Assitance Publique Hôpitaux de Marseille
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
awake brain surgery
Arm Description
Exploration of the cortical area of the brain awake surgery
Outcomes
Primary Outcome Measures
localization of cortical areas
Detection the activity of neurons by the signal of functional MRI
Secondary Outcome Measures
Full Information
NCT ID
NCT02876016
First Posted
August 12, 2016
Last Updated
August 17, 2016
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT02876016
Brief Title
Cerebral Bases Bodily Representations
Acronym
EBA
Official Title
Cerebral Bases Bodily Representations: Imaging Approach by Functional Magnetic Resonance, Cortical Stimulation Corticographie and Surgery Awake
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2016 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Bring elements of understanding to the study of brain organization bodily representations. The body is organized into multiple, distinct levels of representation. The body schema is an unconscious and dynamic representation of his body, updated constantly, resulting from the convergence of multiple sensory information, which articulates with the motor systems to participate in the genesis of the action. The self-image corresponds to a more abstract representation of the body, covering symbolic and imaginary aspects drawn from the emotional life of the individual. Finally, the body of another person engages simultaneously shared and differential representational systems that allow understanding the actions of others while preserving the identity of the agent responsible for the action. These various bodies represented subtly interacting and participating in equilibrium, the self-awareness building as being curious, social and acting. Brain organization bodily representations remains a fundamental question still poorly explored that is of major scientific interest because of its influence on identity and social construction, and the serious repercussions that are their problems, also for the individual and society. This project aims to deepen this hypothesis using a methodology combining functional imaging and awake surgery. The richness of this project lies in the innovative methods of investigation, and in the plurality of disciplines (neuropsychology, neurophysiology, neuroimaging and neurosurgery) and teams (clinical and research) grouped for wear.
The subjects enrolled in this study are all candidates in patients with awakened provided surgery for therapeutic reasons, and volunteer to participate in this experiment. Awake neurosurgery is for patients with glial tumors, but also brain metastases and intra-parenchymal cavernomas. A first experimental session will be held in pre-operative period. Patients realize a functional magnetic resonance imaging (fMRI) brain to define a precise functional mapping of cortical structures, including lateral occipital, involved in body representation. The second experimental session will be conducted in the neurosurgical intervention, practiced one to four weeks later.
This dual approach that combines the functional stimulation of a cortical area (imaging) and functional inhibition (in surgery) allows you to make extremely robust scientific arguments about the causal relationships linking structure and function
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glial Tumors
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
awake brain surgery
Arm Type
Experimental
Arm Description
Exploration of the cortical area of the brain awake surgery
Intervention Type
Device
Intervention Name(s)
functional MRI
Intervention Description
locate the cerebral bases in functional imaging
Primary Outcome Measure Information:
Title
localization of cortical areas
Description
Detection the activity of neurons by the signal of functional MRI
Time Frame
36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age greater than 18 years
Candidate awake in a long surgery
Carrying on an original tumor glial parietal or temporal
Normal global cognitive efficiency score greater than or equal to 27
Exclusion Criteria:
Patient ambidextrous or left
Non glial tumor
Tumor not involving the temporal or parietal lobes
Consumption of non-drug substance
Visual perceptual disorder and or space
Global Cognitive Impairment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Olivier FELICIAN, PU-PH
Email
olivier.felician@ap-hm.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Urielle DESALBRES, Director
Phone
04.91.38.27.47
Email
drci@ap-hm.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier FELICIAN, PU-PH
Organizational Affiliation
Assitance Publique Hôpitaux de Marseille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assitance Publique Hôpitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Urielle DESALBRES, Director
Phone
04.91.38.27.47
Email
drci@ap-hm.fr
First Name & Middle Initial & Last Name & Degree
Jean DHORNE, Project Manager
Phone
04.91.38.27.47
Email
drci@ap-hm.fr
First Name & Middle Initial & Last Name & Degree
Olivier FELICIAN, PUPH
12. IPD Sharing Statement
Plan to Share IPD
No
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Cerebral Bases Bodily Representations
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