- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07650994
Movie-Watching Functional MRI for Mapping Brain Function in Neurosurgical Patients
June 11, 2026 updated by: Yanmei, Tie, Brigham and Women's Hospital
Naturalistic Neuroimaging for Neurosurgical Brain Mapping
We are doing this research to 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.
We hope to 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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
90
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yanmei Tie, PhD
- Phone Number: 617-378-2649
- Email: ytie@bwh.harvard.edu
Study Contact Backup
- Name: Laura Rigolo
- Phone Number: 617-732-5192
- Email: lrigolo@bwh.harvard.edu
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Brigham and Women's Hospital
-
Contact:
- Yanmei Tie, PhD
- Phone Number: 617-378-2649
- Email: ytie@bwh.harvard.edu
-
Contact:
- Laura Rigolo
- Phone Number: 617-732-5192
- Email: lrigolo@bwh.harvard.edu
-
Principal Investigator:
- Yanmei Tie, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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;
- Passes prescreening and standard of care screenings for 3 Tesla MRI;
- Willing to participate in the additional study scan and neuropsychological assessment visit;
- Informed consent form signed by the subject or legally acceptable representative.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: FMRI and Neuropsychological Assessments
|
Functional 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).
Other Names:
Neuropsychological 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Language localization
Time Frame: From enrollment to up to 6 months after brain surgery.
|
Sensitivity and specificity based on the proportion of activation within and outside of language regions-of-interest (ROIs).
|
From enrollment to up to 6 months after brain surgery.
|
|
Language lateralization
Time Frame: From enrollment to up to 6 months after brain surgery.
|
Laterality index (LI) based on proportion of activation in the left vs. right hemisphere in language regions-of-interest (ROIs).
|
From enrollment to up to 6 months after brain surgery.
|
|
FMRI language activations concordance with language fiber tracts
Time Frame: From enrollment to up to 6 months after brain surgery.
|
Concordance with language fiber tracts identified by diffusion MRI in terms of the Euclidean distance between fMRI language activations and the tracts.
|
From enrollment to up to 6 months after brain surgery.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality metrics based on electrocortical stimulation (ECS)
Time Frame: From enrollment to up to 6 months after brain surgery.
|
Sensitivity and specificity computed relative to ECS positive/negative areas.
|
From enrollment to up to 6 months after brain surgery.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Yanmei Tie, PhD, Brigham and Women's Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Hasson U, Nir Y, Levy I, Fuhrmann G, Malach R. Intersubject synchronization of cortical activity during natural vision. Science. 2004 Mar 12;303(5664):1634-40. doi: 10.1126/science.1089506.
- Hasson U, Malach R, Heeger DJ. Reliability of cortical activity during natural stimulation. Trends Cogn Sci. 2010 Jan;14(1):40-8. doi: 10.1016/j.tics.2009.10.011. Epub 2009 Dec 11.
- Black DF, Vachha B, Mian A, Faro SH, Maheshwari M, Sair HI, Petrella JR, Pillai JJ, Welker K. American Society of Functional Neuroradiology-Recommended fMRI Paradigm Algorithms for Presurgical Language Assessment. AJNR Am J Neuroradiol. 2017 Oct;38(10):E65-E73. doi: 10.3174/ajnr.A5345. Epub 2017 Aug 31.
- Sair HI, Yahyavi-Firouz-Abadi N, Calhoun VD, Airan RD, Agarwal S, Intrapiromkul J, Choe AS, Gujar SK, Caffo B, Lindquist MA, Pillai JJ. Presurgical brain mapping of the language network in patients with brain tumors using resting-state fMRI: Comparison with task fMRI. Hum Brain Mapp. 2016 Mar;37(3):913-23. doi: 10.1002/hbm.23075. Epub 2015 Dec 10.
- Tie Y, Rigolo L, Ozdemir Ovalioglu A, Olubiyi O, Doolin KL, Mukundan S Jr, Golby AJ. A New Paradigm for Individual Subject Language Mapping: Movie-Watching fMRI. J Neuroimaging. 2015 Sep-Oct;25(5):710-20. doi: 10.1111/jon.12251. Epub 2015 May 12.
- Rigolo L, Stern E, Deaver P, Golby AJ, Mukundan S Jr. Development of a clinical functional magnetic resonance imaging service. Neurosurg Clin N Am. 2011 Apr;22(2):307-14, x. doi: 10.1016/j.nec.2011.01.001.
- Jaaskelainen IP, Koskentalo K, Balk MH, Autti T, Kauramaki J, Pomren C, Sams M. Inter-subject synchronization of prefrontal cortex hemodynamic activity during natural viewing. Open Neuroimag J. 2008;2:14-9. doi: 10.2174/1874440000802010014. Epub 2008 Apr 1.
- Finn ES, Glerean E, Khojandi AY, Nielson D, Molfese PJ, Handwerker DA, Bandettini PA. Idiosynchrony: From shared responses to individual differences during naturalistic neuroimaging. Neuroimage. 2020 Jul 15;215:116828. doi: 10.1016/j.neuroimage.2020.116828. Epub 2020 Apr 7.
- Yao S, Rigolo L, Yang F, Vangel MG, Wang H, Golby AJ, Liebenthal E, Tie Y. Movie-watching fMRI for presurgical language mapping in patients with brain tumour. J Neurol Neurosurg Psychiatry. 2022 Feb;93(2):220-221. doi: 10.1136/jnnp-2020-325738. Epub 2021 Jun 25. No abstract available.
- Unadkat P, Fumagalli L, Rigolo L, Vangel MG, Young GS, Huang R, Mukundan S Jr, Golby A, Tie Y. Functional MRI Task Comparison for Language Mapping in Neurosurgical Patients. J Neuroimaging. 2019 May;29(3):348-356. doi: 10.1111/jon.12597. Epub 2019 Jan 16.
- Tikka P, Kauttonen J, Hlushchuk Y. Narrative comprehension beyond language: Common brain networks activated by a movie and its script. PLoS One. 2018 Jul 3;13(7):e0200134. doi: 10.1371/journal.pone.0200134. eCollection 2018.
- Wilson SM, Molnar-Szakacs I, Iacoboni M. Beyond superior temporal cortex: intersubject correlations in narrative speech comprehension. Cereb Cortex. 2008 Jan;18(1):230-42. doi: 10.1093/cercor/bhm049. Epub 2007 May 15.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
September 1, 2026
Primary Completion (Estimated)
March 31, 2029
Study Completion (Estimated)
March 31, 2029
Study Registration Dates
First Submitted
June 11, 2026
First Submitted That Met QC Criteria
June 11, 2026
First Posted (Actual)
June 16, 2026
Study Record Updates
Last Update Posted (Actual)
June 16, 2026
Last Update Submitted That Met QC Criteria
June 11, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2026P001172
- R01DC020965 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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