Movie-Watching Functional MRI for Mapping Brain Function in Neurosurgical Patients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-70
SponsorBrigham and Women's Hospital
About this trial
This research will compare a new type of functional MRI (fMRI) called naturalistic viewing (also called movie watching) to standard clinical fMRI techniques. Standard clinical fMRI currently uses multiple tasks such as reading and responding to words or sentences to determine which areas of the brain are responsible for language. Surgeons can use this information to help plan brain surgeries. This research will help determine if the movie-watching fMRI is equivalent or better than the standard task-based fMRI. If so, it could be useful for planning patients' surgeries in the future, without the need for multiple tasks.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Any sex, age between 21 to 70 years;
Known or suspected glioma (lesion) of the brain;
English speaking;
Patients with clinical fMRI scheduled (or pending scheduling) for presurgical planning at BWH ordered by a BWH clinician;
Disqualifiers
Contraindications to MRI: Note: MRI screening will be performed by radiology staff as part of their standard process for their clinical scans and if subjects do not pass the screen, MRI will not be performed.
Pregnancy or possible pregnancy: Female participants under 55 (or 45 with menstrual cycle in the past 12 months) who may be pregnant. Per policy: potential subjects will be asked if they are pregnant and excluded if they say yes. If unsure, pregnancy testing will be performed. Any subjects with positive result will be excluded.
Trial design
Design model
Single group
Treatments tested in this trial
Functional magnetic resonance imaging (fMRI)
Other interventionFunctional magnetic resonance imaging (fMRI) is a type of non-invasive imaging that measures blood oxygen level-dependent (BOLD) signal changes in the brain when a task is performed (such as reading) or BOLD signal changes during resting or watching naturalistic stimuli (such as movie clips).
Neuropsychological Assessments
BehavioralNeuropsychological assessments are standardized tests used to evaluate cognitive, behavioral, and emotional functions that reflect the performance of different brain systems. These tests can be on paper or on a computer.
Treatment groups
90 Participants
are divided into 1 treatment groupGroup A: FMRI and Neuropsychological AssessmentsExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Language localization
Sensitivity and specificity based on the proportion of activation within and outside of language regions-of-interest (ROIs).
Time frame
From enrollment to up to 6 months after brain surgery.2
Language lateralization
Laterality index (LI) based on proportion of activation in the left vs. right hemisphere in language regions-of-interest (ROIs).
Time frame
From enrollment to up to 6 months after brain surgery.3
FMRI language activations concordance with language fiber tracts
Concordance with language fiber tracts identified by diffusion MRI in terms of the Euclidean distance between fMRI language activations and the tracts.
Time frame
From enrollment to up to 6 months after brain surgery.Secondary outcomes
1
Quality metrics based on electrocortical stimulation (ECS)
Sensitivity and specificity computed relative to ECS positive/negative areas.
Time frame
From enrollment to up to 6 months after brain surgery.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Brigham and Women's Hospital
Lead sponsor
National Institute on Deafness and Other Communication Disorders (NIDCD)
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: