Language Function in Patients With Brain Tumors

Brain Cancer Clinical Trial

Official title:

Reorganization of Language Function in Patients With Brain Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00599703
• Other study ID #: 05-043
• Status: Completed
• Phase: N/A
• First received: January 11, 2008
• Last updated: July 7, 2009
• Start date: May 2005
• Est. completion date: March 2009

Study information

• Verified date: July 2009
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to use an imaging method called functional magnetic resonance imaging (fMRI) in patients who have a tumor near an area of the brain that is believed to control language. The fMRI is a new kind of imaging that uses a strong magnetic field to look at functioning brain tissue. This kind of imaging will be used to study the effect of the brain tumor on your speech.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient in whom a tumor invades or is directly adjacent to the expected location of one of the language centers.

• At least 18 years of age

• English as first language

Exclusion Criteria:

• Patients with high grade tumors

• History of significant psychiatric condition (e.g. schizophrenia, obsessive-compulsive disorder, significant dementia),

• History of the following neurological conditions: CVA, demyelinating conditions, cerebral palsy, Alzheimer's disease.

• History of significant claustrophobic reactions.

• Pregnancy

• Standard contraindications to MR examinations (e.g. implanted stimulator)

• Patients, who were treated prior to our first scan, will not be eligible to participate in this study

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Brain Cancer
• CNS Cancer

Intervention

Other:
• fMRI Scan, pre- and post language evaluation
All subjects will undergo functional MR imaging, pre- and post-surgical language evaluation, and electrocortical stimulation mapping. The brain tumor patients will undergo these procedures twice.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To identify language organization prior to surgery in patients in whom a tumor invades or is directly adjacent to the expected location of one of the language centers.		conclusion of study	No
Secondary	To assess language reorganization over time.		conclusion of study	No

External Links

•   Memorial Sloan-Kettering Cancer Center