Clinical Trials Directory

Trials / Completed

CompletedNCT03496181

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

Status
Completed
Phase
Study type
Observational
Enrollment
32 (actual)
Sponsor
Memorial Sloan Kettering Cancer Center · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALMultilingual Aphasia ExaminationFor 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_TESTLanguage paradigms + RS fMRI10 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_TESTLanguage paradigms + RS fMRI + one anatomical sequence10 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.

Timeline

Start date
2018-03-30
Primary completion
2025-05-08
Completion
2025-05-08
First posted
2018-04-12
Last updated
2025-05-11

Locations

3 sites across 2 countries: United States, Italy

Source: ClinicalTrials.gov record NCT03496181. Inclusion in this directory is not an endorsement.