Establishing the Language Network With Independent Component Analysis of Resting State MRI

NCT ID: NCT02577757

Last Updated: 2015-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2016-05-31

Brief Summary

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Proceed to an analysis of sensitivity and specificity results of the fMRI language network obtained in two ways: by providing a conventional language test and independent component analysis. These two methods will be compared to the reference method what the cortical intraoperative mapping.

Detailed Description

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Patients with brain tumors including malignant gliomas located in eloquent areas have long been considered inoperable because of median survival and predictable postoperative sequelae. The improved prognosis with chemoradiotherapy and surgical resection as complete as possible questioned this attitude. The goal is to operate those patients without additional disabilities. The cortical electrostimulation intraoperative mapping in awake surgery can meet the eloquent areas. Identifying with fMRI these same areas to better specify in advance the way initially and shortened the time to awake exploratory surgery which improves patient comfort. However anxiety induced by the review in a pre-operative setting, a debutante aphasia often make problematic the realization of a formal language test. The analysis in the low frequency of spontaneous oscillations of large neuronal networks can help isolate network of language at rest without particular language test at the group analysis. This methodology, however, needs to be validated at the individual level before it can be applied to pathology.

Proceed to an analysis of sensitivity and specificity results of the fMRI language network obtained in two ways: by providing a conventional language test and independent component analysis. These two methods will be compared to the reference method what the cortical intraoperative mapping.

Conditions

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Languages

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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healthy volunteers

achieving functional MRI

Group Type OTHER

MRI

Intervention Type DEVICE

MRI

Eligible patients with awakened surgery

achieving functional MRI

Group Type EXPERIMENTAL

MRI

Intervention Type DEVICE

MRI

Interventions

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MRI

MRI

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Persons major and minor.
* Having given their written consent, or whose parents have given their written consent for minors.
* Affiliated with the social security system
* All patients eligible adults in awake surgery
* Affiliated with the social security system
* patient given their written consent

Exclusion Criteria

* Contraindications to MRI
* Pregnant or breastfeeding women
Minimum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Angers

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ARAM TER MINASSIAN, MD

Role: PRINCIPAL_INVESTIGATOR

UH ANGERS

Locations

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CHU Angers

Angers, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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ARAM TER MINASSIAN, physician

Role: CONTACT

+33.2.41.35.52.31

Facility Contacts

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Aram TER MINASSIAN, Physician

Role: primary

+33.2.41.35.52.31

Other Identifiers

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CHU-Promoteur 2012-04

Identifier Type: -

Identifier Source: org_study_id

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