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

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03496181
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Memorial Sloan Kettering Cancer Center
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Andrei Holodny, MD
Principal Investigator Affiliation	Memorial Sloan Kettering Cancer Center
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Active, not recruiting
Countries	Italy, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioma, Glioma of Brain, Glioma of Spinal Cord
Study Website:	View Trial Website

Arms & Interventions

Arms

: 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.

: 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).

Interventions

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

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Memorial Sloan Kettering Cancer Center, New York, New York

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Address

Memorial Sloan Kettering Cancer Center

New York, New York, 10021

City College of New York, New York, New York

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Address

City College of New York

New York, New York, 10031

International Sites

IMT School of Advance Studies Lucca, Lucca, Lucca LU, Italy

Status

Address

IMT School of Advance Studies Lucca

Lucca, Lucca LU, 55100

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