Clinical trial NCT03496181: Evaluation of Functional Magnetic Resonance Imaging (fMRI) in Patients Who Speak Two Languages Fluently
Official title: Graph Theoretical Analysis of Pre-operative fMRI Data in Bilingual Patients With Brain Tumors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glioma
Glioma of Brain
Glioma of Spinal Cord
Keywords: fMRI
MRI
18-121
Memorial Sloan Kettering Cancer Center
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2018-04-12
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Potential research participants will be identified by a member of the patient's treatment team, listed protocol investigators, or Neuroradiology research team at Memorial Sloan Kettering Cancer Center (MSKCC).

Brief summary: Functional magnetic resonance imaging (fMRI) is a non-invasive test used to detect changes in brain activity by taking picture of changes in blood flow. The imaging helps doctors better understand how the brain works. Task based fMRI (TB fMRI) prompts patients to perform different activities (e.g. word selection in a reading task), and is routinely performed on patients in preparation for a Neurological surgery (surgery that involves the nervous system, brain and/or spinal cord). The purpose is to locate areas of the brain that control speech and movement; these images will help make decisions about patient surgeries. However, there are however gaps in knowledge specific to the language areas of the brain, especially for non-English patients and bilingual patients (those who are fluent in more than one language). This study proposes to evaluate if resting state fMRI (RS fMRI) that does not require any tasks, along with a novel way to analyze these images using "graphy theory," may provide more information. Graph theory is a new mathematical method to analyze the fMRI data. The overall goal is to determine if graph theory analysis on RS fMRI may reduce differences in health care treatment and outcomes for non-English speaking and bilingual patients. We hope that the results of this study will allow doctors to perform pre-operative fMRI in patients who do not speak English.


Eligibility criteria: Inclusion Criteria:

All patients and volunteers will be recruited by listed consenting professionals. Volunteers do not need to be MSK employees.

* Patients/ healthy volunteers ≥ 18 years old
* Patients/ healthy volunteers must be able to perform the language paradigms on cue while inside the scanner
* Patients/ healthy volunteers who are monolingual English speakers, early bilinguals (English and Spanish) or late bilinguals (English and Spanish)
* Patients must be newly diagnosed with a glioma (from prior histology) or must be suspected to have a glioma on imaging (to be confirmed by post-operative histology)
* Patient's location of the tumor must involve the expected location of Broca's area (left pars opercularis and/or pars triangularis). This determination will be made on the basis of a pre-operative MRI by a fellowship-trained Neuroradiologist

Early bilingual will be defined as acquiring proficiency in the second language before 10 years of age.

Exclusion Criteria:

* Patients/ volunteers who are unable to comply or complete MRI exams as per the Department of Radiology's standard guidelines (e.g.: claustrophobia, high levels of anxiety, pacemaker etc.)
* Patient/ volunteers who are unable to perform the language paradigms on cue while inside the scanner (due to weakness, deafness, inability to understand or follow instructions etc.)
* Volunteers with a history of neurological disorders, psychiatric disorders or cancer
* Female patients/ volunteers who are pregnant or nursing
* Patients/ volunteers from the vulnerable population, as defined by 45 CFR 46

Primary outcomes:
measure: Comparison of RS fMRI and overall TB fMRI
timeFrame: Through study completion, an average of 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: New York
country: United States
facility: City College of New York
state: New York
city: Lucca
country: Italy
facility: IMT School of Advance Studies Lucca
state: Lucca LU
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Andrei Holodny, MD
role: PRINCIPAL_INVESTIGATOR
References: