Evaluation of Functional Magnetic Resonance Imaging (fMRI) in Patients Who Speak Two Languages Fluently

May 8, 2025 updated by: Memorial Sloan Kettering Cancer Center

Graph Theoretical Analysis of Pre-operative fMRI Data in Bilingual Patients With Brain Tumors

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Kyung Peck, MSc, PhD
  • Phone Number: 212-639-8522
  • Email: peckk@mskcc.org

Study Locations

  • Italy
    • Lucca LU
      • Lucca, Lucca LU, Italy, 55100
        • IMT School of Advance Studies Lucca
  • United States
    • New York
      • New York, New York, United States, 10021
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, United States, 10031
        • City College of New York

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Bilingual Participants with Glioma

Bilingual (English and Spanish speaking) patients will be recruited from the clinical service of the Department of Neurosurgery of MSK. All patients on the Neurosurgery service scheduled to undergo a resection of a tumor in or adjacent to the primary language areas will be screened to participate in this study.

The study will be performed in concert with patient's regularly scheduled clinical care for his/her brain tumor. Clinical care (which will be performed whether or not the patient participates in the current study) will include: 1) pre-operative routine (anatomical) MRI and fMRI, 2) the surgery to remove the tumor, 3) intra-operative cortical stimulation to identify the essential motor and/or language areas. It should be stressed that neither the brain tumor surgery, nor the intra-operative cortical mapping will be changed in any way from routine practice.
Behavioral: Multilingual Aphasia Examination

For patients only prior to MRI scans.

The MAE contains eleven subtests in five categories which may be used to assess both languages in bilinguals and the participant's primary language in monolinguals: Oral Expression, Spelling, Oral Verbal Understanding, Reading, and Rating Scales. Subtests are scored for accuracy of individual items on a three-point scoring system (0, 1, 2). Contained within these domains are The Token Test, Aural Comprehension of Words and Phrases and Visual Naming which naturally parallel fMRI and direct cortical stimulation behavioral assays already in place for clinical use (phonemic fluency, auditory responsive naming and confrontation naming respectively). The MAE is expected to take under 50 minutes.

Diagnostic test: Language paradigms + RS fMRI
10 monolingual patients: 2 language paradigms + RS fMRI = 7x3 = 21 minutes 10 early bilingual patients: 2 language paradigms+ RS fMRI = 7x3 = 21 minutes 10 late bilingual patients: 2 language paradigms+ RS fMRI = 7x3 = 21 minutes
Healthy Volunteers
Normal, healthy volunteers who express interest in participation and who meet the eligibility criteria will be recruited for this study. It is anticipated that healthy volunteers will mostly consist of medical professionals. They will consist of 10 monolinguals (defined as native English speakers), 10 early bilinguals (defined as acquiring proficiency in the second language before 10 years of age), and 10 late bilinguals (defined as acquiring proficiency in the second language after 10 years of age).
Diagnostic test: Language paradigms + RS fMRI + one anatomical sequence

10 monolingual English volunteers: 2 task language paradigms* + 1 Resting State fMRI + one anatomical sequence for a total of approximately 25 minutes.

10 late bilingual volunteers: 4 language paradigms (2 English + 2 Spanish) + 1 Resting State fMRI + one anatomical sequence for a total of approximately 39 minutes.

10 early bilingual volunteers: 4 language paradigms (2 English + 2 Spanish) + 1 Resting State fMRI + one anatomical sequence for a total of approximately 39 minutes.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Comparison of RS fMRI and overall TB fMRI
Time Frame: Through study completion, an average of 1 day
Through study completion, an average of 1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Memorial Sloan Kettering Cancer Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Andrei Holodny, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 30, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 8, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 8, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 3, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 12, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 11, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 18-121

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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