NCT02577757

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

September 18, 2015

Completed
28 days until next milestone

First Posted

Study publicly available on registry

October 16, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

October 16, 2015

Status Verified

October 1, 2015

Enrollment Period

3.5 years

First QC Date

September 18, 2015

Last Update Submit

October 13, 2015

Conditions

Languages

Keywords

Languages networkFunctional MRI

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

healthy volunteers

OTHER

achieving functional MRI

Device: MRI

Eligible patients with awakened surgery

EXPERIMENTAL

achieving functional MRI

Device: MRI

Interventions

MRIDEVICE

MRI

Eligible patients with awakened surgeryhealthy volunteers

Eligibility Criteria

Age7 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Contraindications to MRI
  • Pregnant or breastfeeding women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Angers

Angers, 49933, France

RECRUITING

MeSH Terms

Conditions

Language

Condition Hierarchy (Ancestors)

CommunicationBehavior

Study Officials

  • ARAM TER MINASSIAN, MD

    UH ANGERS

    PRINCIPAL INVESTIGATOR

Central Study Contacts

ARAM TER MINASSIAN, physician

CONTACT

+33.2.41.35.52.31ArTerMinassian@chu-angers.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2015

First Posted

October 16, 2015

Study Start

November 1, 2012

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

October 16, 2015

Record last verified: 2015-10

Locations

FR(1)