Language Function in Patients With Brain Tumors

• Sponsor: Memorial Sloan Kettering Cancer Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00599703
• Collaborator: (none)
• Enrollment: 7
• Location: 1
• Duration (Months): 46
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Brain Cancer; CNS Cancer	Other: fMRI Scan, pre- and post language evaluation

Study Design

• Study Type: Observational
• Actual Enrollment: 7 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Reorganization of Language Function in Patients With Brain Tumors
• Study Start Date: May 1, 2005
• Actual Primary Completion Date: Mar 1, 2009
• Actual Study Completion Date: Mar 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

1. To assess language reorganization over time. [conclusion of study]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Memorial Sloan-Kettering Cancer Center

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00599703
• Other Study ID Numbers: 05-043
• First Posted: Jan 24, 2008
• Last Update Posted: Jul 8, 2009
• Last Verified: Jul 1, 2009

• Additional relevant MeSH terms: Brain Neoplasms

Study Results

No Results Posted as of Jul 8, 2009