GliomaNCT07650994
Movie-Watching Functional MRI for Mapping Brain Function in Neurosurgical Patients
A study testing Functional magnetic resonance imaging (fMRI) and Neuropsychological Assessments in people with Glioma and Brain Tumor Adult, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Glioma, Brain Tumor Adult
- What is being tested?
- Functional magnetic resonance imaging (fMRI) and Neuropsychological Assessments
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 31 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Yanmei Tie, PhD, 617-378-2649, ytie@bwh.harvard.edu
Laura Rigolo, 617-732-5192, lrigolo@bwh.harvard.edu
About this study
Official title: Naturalistic Neuroimaging for Neurosurgical Brain Mapping
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.
- Conditions
- Glioma, Brain Tumor Adult
- Being tested
- Functional magnetic resonance imaging (fMRI), Neuropsychological Assessments
- Keywords
- Movie Functional Magnetic Resonance Imaging, Clinical Functional Magnetic Resonance Imaging, Presurgical Planning, Presurgical Brain Mapping
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional magnetic resonance imaging (fMRI)Other
Also called fMRI
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).
Neuropsychological AssessmentsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| FMRI and Neuropsychological Assessments | Experimental | Not described Receives: Other: Functional magnetic resonance imaging (fMRI); Behavioral: Neuropsychological Assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Language localization
Sensitivity and specificity based on the proportion of activation within and outside of language regions-of-interest (ROIs).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: From enrollment to up to 6 months after brain surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Mar 2029 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for GliomaStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Principal investigator, Yanmei, Tie, Brigham and Women's Hospital
- Investigators
- Yanmei Tie, PhD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07650994
- Sponsor's protocol ID
- 2026P001172
- Other IDs
- R01DC020965
- Status last verified
- Jun 2026
- First submitted
- 11 Jun 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 15016991Hasson 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.
PubMed 20004608Black 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.
PubMed 28860215Sair 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.
PubMed 26663615Tie 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.
PubMed 25962953Rigolo 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.
PubMed 21435578Jaaskelainen 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.
PubMed 19018313Finn 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.
PubMed 32276065Yao 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.
PubMed 34172562Unadkat 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.
PubMed 30648771Tikka 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.
PubMed 29969491Wilson 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.
PubMed 17504783
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Naturalistic Neuroimaging for Neurosurgical Brain Mapping
- ClinicalTrials.gov ID
- NCT07650994
- Acronym / sponsor ID
- 2026P001172
- Conditions
- Glioma, Brain Tumor Adult
- Keywords
- Movie Functional Magnetic Resonance Imaging, Clinical Functional Magnetic Resonance Imaging, Presurgical Planning, Presurgical Brain Mapping
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Mar 2029 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 16 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FMRI and Neuropsychological Assessments | Experimental | Other: Functional magnetic resonance imaging (fMRI), Behavioral: Neuropsychological Assessments |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional magnetic resonance imaging (fMRI)Also: fMRIFunctional 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 | FMRI and Neuropsychological Assessments |
| Neuropsychological AssessmentsNeuropsychological 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. | Behavioural | FMRI and Neuropsychological Assessments |
Primary outcome
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).
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).
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.
1 secondary outcome
Quality metrics based on electrocortical stimulation (ECS)
Time frame: From enrollment to up to 6 months after brain surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Background: PubMed 15016991Hasson 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.
- Background: PubMed 20004608Hasson 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.
- Background: PubMed 28860215Black 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.
- Background: PubMed 26663615Sair 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.
- Background: PubMed 25962953Tie 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.
- Background: PubMed 21435578Rigolo 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.
- Background: PubMed 19018313Jaaskelainen 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.
- Background: PubMed 32276065Finn 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.
- Background: PubMed 34172562Yao 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.
- Background: PubMed 30648771Unadkat 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.
- Background: PubMed 29969491Tikka 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.
- Background: PubMed 17504783Wilson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yanmei Tie, PhD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional magnetic resonance imaging (fMRI) and Neuropsychological Assessments in people with Glioma and Brain Tumor Adult, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yanmei Tie, PhD (617-378-2649, ytie@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Language localization (time frame: From enrollment to up to 6 months after brain surgery.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07650994, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.