- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03496181
Evaluation of Functional Magnetic Resonance Imaging (fMRI) in Patients Who Speak Two Languages Fluently
Graph Theoretical Analysis of Pre-operative fMRI Data in Bilingual Patients With Brain Tumors
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Andrei Holodny, MD
- Phone Number: 212-639-3182
- Email: holodnya@mskcc.org
Study Contact Backup
- Name: Kyung Peck, MSc, PhD
- Phone Number: 212-639-8522
- Email: peckk@mskcc.org
Study Locations
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Lucca LU
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Lucca, Lucca LU, Italy, 55100
- IMT School of Advance Studies Lucca
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New York
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New York, New York, United States, 10021
- Memorial Sloan Kettering Cancer Center
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New York, New York, United States, 10031
- City College of New York
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
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
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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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. |
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.
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
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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).
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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
Outcome Measure |
Time Frame |
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Comparison of RS fMRI and overall TB fMRI
Time Frame: Through study completion, an average of 1 day
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Through study completion, an average of 1 day
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Collaborators and Investigators
Investigators
- Principal Investigator: Andrei Holodny, MD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-121
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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