Cerebral Bases Bodily Representations
EBA
2 other identifiers
interventional
20
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 12, 2016
CompletedFirst Posted
Study publicly available on registry
August 23, 2016
CompletedStudy Start
First participant enrolled
December 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedAugust 23, 2016
August 1, 2016
1 year
August 12, 2016
August 17, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
localization of cortical areas
Detection the activity of neurons by the signal of functional MRI
36 months
Study Arms (1)
awake brain surgery
EXPERIMENTALExploration of the cortical area of the brain awake surgery
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assitance Publique Hôpitaux de Marseille
Marseille, 13354, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Olivier FELICIAN, PU-PH
Assitance Publique Hôpitaux de Marseille
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 12, 2016
First Posted
August 23, 2016
Study Start
December 1, 2016
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
August 23, 2016
Record last verified: 2016-08
Data Sharing
- IPD Sharing
- Will not share