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

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Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02577757
• Other study ID #: CHU-Promoteur 2012-04
• Status: Recruiting
• Phase: N/A
• First received: September 18, 2015
• Last updated: October 13, 2015
• Start date: November 2012
• Est. completion date: May 2016

Study information

• Verified date: October 2015
• Source: University Hospital, Angers
• Contact: ARAM TER MINASSIAN, physician
• Phone: +33.2.41.35.52.31
• Email: ArTerMinassian[@]chu-angers.fr
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 7 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Languages

Intervention

Device:
• MRI
MRI

Locations

Country	Name	City	State
France	CHU Angers	Angers

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No