Evaluation of Functional Magnetic Resonance Imaging (fMRI) in Patients Who Speak Two Languages Fluently
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|ClinicalTrials.gov Identifier: NCT03496181|
Recruitment Status : Recruiting
First Posted : April 12, 2018
Last Update Posted : April 4, 2019
|Condition or disease||Intervention/treatment|
|Glioma Glioma of Brain Glioma of Spinal Cord||Behavioral: Multilingual Aphasia Examination Diagnostic Test: Language paradigms + RS fMRI Diagnostic Test: Language paradigms + RS fMRI + one anatomical sequence|
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|Official Title:||Graph Theoretical Analysis of Pre-operative fMRI Data in Bilingual Patients With Brain Tumors|
|Actual Study Start Date :||March 30, 2018|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||September 2019|
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
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.
- Comparison of RS fMRI and overall TB fMRI [ Time Frame: Through study completion, an average of 1 day ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03496181
|Contact: Andrei Holodny, MDemail@example.com|
|Contact: Kyung Peck, MSc, PhDfirstname.lastname@example.org|
|United States, New York|
|Memorial Sloan - Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10021|
|Contact: Andrei Holodny, MD 212-639-3182 email@example.com|
|City College of New York||Recruiting|
|New York, New York, United States, 10031|
|Contact: Hernan Maske, PhD 212-650-6847 firstname.lastname@example.org|
|Principal Investigator:||Andrei Holodny, MD||Memorial Sloan Kettering Cancer Center|