Glial TumorsEBANCT02876016
Cerebral Bases Bodily Representations
A study testing functional MRI in people with Glial Tumors, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glial Tumors
- What is being tested?
- functional MRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2016to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Olivier FELICIAN, PU-PH contact
France1 site
Assitance Publique Hôpitaux de Marseille
Marseille, 13354
Urielle DESALBRES, Director, 04.91.38.27.47, drci@ap-hm.fr
Jean DHORNE, Project Manager, 04.91.38.27.47, drci@ap-hm.fr
About this study
Official title: Cerebral Bases Bodily Representations: Imaging Approach by Functional Magnetic Resonance, Cortical Stimulation Corticographie and Surgery Awake
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
- Conditions
- Glial Tumors
- Being tested
- functional MRI
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
functional MRIDevice
locate the cerebral bases in functional imaging
| Study group | Role | What they receive |
|---|---|---|
| awake brain surgery | Experimental | Exploration of the cortical area of the brain awake surgery Receives: Device: functional MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
localization of cortical areas
Detection the activity of neurons by the signal of functional MRI
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2016 (estimated)
- Study startDec 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glial TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier FELICIAN, PU-PH, Principal investigator, Assitance Publique Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02876016
- Sponsor's protocol ID
- 2014-34
- Other IDs
- 2014-A01449-38
- Acronym
- EBA
- Status last verified
- Aug 2016
- First submitted
- 12 Aug 2016
- Last updated
- 23 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Bases Bodily Representations: Imaging Approach by Functional Magnetic Resonance, Cortical Stimulation Corticographie and Surgery Awake
- ClinicalTrials.gov ID
- NCT02876016
- Acronym / sponsor ID
- EBA / 2014-34
- Conditions
- Glial Tumors
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 23 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| awake brain surgery | Experimental | Device: functional MRIExploration of the cortical area of the brain awake surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| functional MRIlocate the cerebral bases in functional imaging | Device | awake brain surgery |
Primary outcome
localization of cortical areas
Time frame: 36 months
Detection the activity of neurons by the signal of functional MRI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier FELICIAN, PU-PH contact
Olivier FELICIAN, PU-PH principal investigator
Assitance Publique Hôpitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing functional MRI in people with Glial Tumors, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Olivier FELICIAN, PU-PH (olivier.felician@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
localization of cortical areas (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2016.