Language Function in Patients With Brain Tumors
Reorganization of Language Function in Patients With Brain Tumors
1 other identifier
observational
7
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started May 2005
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2005
CompletedFirst Submitted
Initial submission to the registry
January 11, 2008
CompletedFirst Posted
Study publicly available on registry
January 24, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedJuly 8, 2009
July 1, 2009
3.8 years
January 11, 2008
July 7, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
To assess language reorganization over time.
conclusion of study
Study Arms (1)
1
neurosurgical patients
Interventions
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.
Eligibility Criteria
MSKCC clinics
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrei Holodny, MD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 11, 2008
First Posted
January 24, 2008
Study Start
May 1, 2005
Primary Completion
March 1, 2009
Study Completion
March 1, 2009
Last Updated
July 8, 2009
Record last verified: 2009-07