NCT07650994

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
31mo left

Started Sep 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 11, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 16, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2029

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2029

Last Updated

June 22, 2026

Status Verified

June 1, 2026

Enrollment Period

2.6 years

First QC Date

June 11, 2026

Last Update Submit

June 17, 2026

Conditions

Keywords

Movie Functional Magnetic Resonance ImagingClinical Functional Magnetic Resonance ImagingPresurgical PlanningPresurgical Brain Mapping

Outcome Measures

Primary Outcomes (3)

  • Language localization

    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

    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

    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 Outcomes (1)

  • Quality metrics based on electrocortical stimulation (ECS)

    From enrollment to up to 6 months after brain surgery.

Study Arms (1)

FMRI and Neuropsychological Assessments

EXPERIMENTAL
Other: Functional magnetic resonance imaging (fMRI)Behavioral: Neuropsychological Assessments

Interventions

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).

Also known as: fMRI
FMRI and Neuropsychological Assessments

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.

FMRI and Neuropsychological Assessments

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (12)

  • 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.

    PMID: 15016991BACKGROUND
  • 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.

    PMID: 20004608BACKGROUND
  • 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.

    PMID: 28860215BACKGROUND
  • 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.

    PMID: 26663615BACKGROUND
  • 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.

    PMID: 25962953BACKGROUND
  • 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.

    PMID: 21435578BACKGROUND
  • 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.

    PMID: 19018313BACKGROUND
  • 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.

    PMID: 32276065BACKGROUND
  • 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.

    PMID: 34172562BACKGROUND
  • 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.

    PMID: 30648771BACKGROUND
  • 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.

    PMID: 29969491BACKGROUND
  • 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.

    PMID: 17504783BACKGROUND

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • Yanmei Tie, PhD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 11, 2026

First Posted

June 16, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

March 31, 2029

Study Completion (Estimated)

March 31, 2029

Last Updated

June 22, 2026

Record last verified: 2026-06

Locations