Movie-Watching Functional MRI for Mapping Brain Function in Neurosurgical Patients

Official title

Naturalistic Neuroimaging for Neurosurgical Brain Mapping

Overview

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.

Interventions

• Other Functional magnetic resonance imaging (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).
• Behavioral 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.

Primary outcome measures

• Language localization [Time frame: From enrollment to up to 6 months after brain surgery.]
• Language lateralization [Time frame: 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.]

Secondary outcome measures (1)

• Quality metrics based on electrocortical stimulation (ECS) [Time frame: From enrollment to up to 6 months after brain surgery.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Diagnostic

Study locations

United States · 1 center

• Brigham and Women's Hospital — Boston

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. PMID 15016991
• 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 20004608
• 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 28860215
• 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 26663615
• 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 25962953
• 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 21435578
• 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 19018313
• 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 32276065

Identifiers

NCT: NCT07650994 · 2026P001172 · R01DC020965

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗