Establishing the Language Network With Independent Component Analysis of Resting State MRI (ICA Langage)

October 13, 2015 updated by: University Hospital, Angers
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49933
        • Recruiting
        • CHU Angers
        • Contact:
        • Principal Investigator:
          • Aram TER MINASSIAN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: healthy volunteers
achieving functional MRI
Device: MRI
MRI
Experimental: Eligible patients with awakened surgery
achieving functional MRI
Device: MRI
MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
MRI data obtained by comparing a formal language test to data obtained by a session of rest independent component analyzed in patients and volunteers
Time Frame: 1 hour
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

Investigators

  • Principal Investigator: ARAM TER MINASSIAN, MD, UH Angers

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Anticipated)

May 1, 2016

Study Completion (Anticipated)

May 1, 2016

Study Registration Dates

First Submitted

September 18, 2015

First Submitted That Met QC Criteria

October 13, 2015

First Posted (Estimate)

October 16, 2015

Study Record Updates

Last Update Posted (Estimate)

October 16, 2015

Last Update Submitted That Met QC Criteria

October 13, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CHU-Promoteur 2012-04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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