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Language Function in Patients With Brain Tumors

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00599703
First Posted: January 24, 2008
Last Update Posted: July 8, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Memorial Sloan Kettering Cancer Center
  Purpose
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.

Condition Intervention
Brain Cancer CNS Cancer Other: fMRI Scan, pre- and post language evaluation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Reorganization of Language Function in Patients With Brain Tumors

Resource links provided by NLM:


Further study details as provided by Memorial Sloan Kettering Cancer Center:

Primary Outcome Measures:
  • 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. [ Time Frame: conclusion of study ]

Secondary Outcome Measures:
  • To assess language reorganization over time. [ Time Frame: conclusion of study ]

Enrollment: 7
Study Start Date: May 2005
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
neurosurgical patients
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
MSKCC clinics
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00599703


Locations
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
Principal Investigator: Andrei Holodny, MD Memorial Sloan Kettering Cancer Center
  More Information

Additional Information:
Responsible Party: Andrei Holodny, M.D., Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00599703     History of Changes
Other Study ID Numbers: 05-043
First Submitted: January 11, 2008
First Posted: January 24, 2008
Last Update Posted: July 8, 2009
Last Verified: July 2009

Additional relevant MeSH terms:
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases