Language Function in Patients With Brain Tumors

This study has been completed.
Sponsor:
Information provided by:
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00599703
First received: January 11, 2008
Last updated: July 7, 2009
Last verified: July 2009
  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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess language reorganization over time. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Andrei Holodny, M.D., Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00599703     History of Changes
Other Study ID Numbers: 05-043
Study First Received: January 11, 2008
Last Updated: July 7, 2009
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 21, 2014