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

Not Applicable

• Conditions: Languages
• Interventions: Device: MRI

• Registration Number: NCT02577757
• Lead Sponsor: University Hospital, Angers

Brief Summary

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

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.

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2015-09-18
• Status Verified: 2015-10
• Study First Submitted QC: 2015-10-13
• Last Update Submitted: 2015-10-13
• Study First Posted: 2015-10-16
• Last Update Posted: 2015-10-16
• Primary Completion: 2016-05
• Study Completion: 2016-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Eligible patients with awakened surgery	MRI	achieving functional MRI
healthy volunteers	MRI	achieving functional MRI

Primary Outcome Measures

Name	Time	Method
MRI data obtained by comparing a formal language test to data obtained by a session of rest independent component analyzed in patients and volunteers	1 hour

Trial Locations

Locations (1)

CHU Angers; 🇫🇷 Angers, France