[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07650994":3,"trial-entities:NCT07650994":145,"trial-summary:NCT07650994":148},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":46,"secondary_outcomes":57,"sex":61,"minimum_age":62,"maximum_age":63,"healthy_volunteers":15,"eligibility_criteria":64,"std_ages":77,"locations":80,"central_contacts":101,"overall_officials":104,"references":106,"see_also_links":144},"NCT07650994","2026P001172","Movie-Watching Functional MRI for Mapping Brain Function in Neurosurgical Patients","Naturalistic Neuroimaging for Neurosurgical Brain Mapping","NOT_YET_RECRUITING","2029-03-31","2026-06","2026-06-22","2026-09-01","Brigham and Women's Hospital","OTHER",false,"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.",null,[19,20],"Glioma","Brain Tumor Adult",[22,23,24,25],"Movie Functional Magnetic Resonance Imaging","Clinical Functional Magnetic Resonance Imaging","Presurgical Planning","Presurgical Brain Mapping","INTERVENTIONAL","DIAGNOSTIC",[29],"NA",{"count":31,"type":32},90,"ESTIMATED",[34,41],{"type":14,"name":35,"description":36,"armGroupLabels":37,"otherNames":39},"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).",[38],"FMRI and Neuropsychological Assessments",[40],"fMRI",{"type":42,"name":43,"description":44,"armGroupLabels":45},"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.",[38],[47,51,54],{"measure":48,"description":49,"timeFrame":50},"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.",{"measure":52,"description":53,"timeFrame":50},"Language lateralization","Laterality index (LI) based on proportion of activation in the left vs. right hemisphere in language regions-of-interest (ROIs).",{"measure":55,"description":56,"timeFrame":50},"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.",[58],{"measure":59,"description":60,"timeFrame":50},"Quality metrics based on electrocortical stimulation (ECS)","Sensitivity and specificity computed relative to ECS positive\u002Fnegative areas.","ALL","21 Years","70 Years",{"inclusion":65,"exclusion":73,"raw_text":76},[66,67,68,69,70,71,72],"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.",[74,75],"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.","Inclusion Criteria:\n\n* Any sex, age between 21 to 70 years;\n* Known or suspected glioma (lesion) of the brain;\n* English speaking;\n* Patients with clinical fMRI scheduled (or pending scheduling) for presurgical planning at BWH ordered by a BWH clinician;\n* Passes prescreening and standard of care screenings for 3 Tesla MRI;\n* Willing to participate in the additional study scan and neuropsychological assessment visit;\n* Informed consent form signed by the subject or legally acceptable representative.\n\nExclusion Criteria:\n\n* 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.\n* 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.",[78,79],"ADULT","OLDER_ADULT",[81],{"facility":13,"city":82,"state":83,"zip":84,"country":85,"contacts":86,"geoPoint":98},"Boston","Massachusetts","02115","United States",[87,92,96],{"name":88,"role":89,"phone":90,"email":91},"Yanmei Tie, PhD","CONTACT","617-378-2649","ytie@bwh.harvard.edu",{"name":93,"role":89,"phone":94,"email":95},"Laura Rigolo","617-732-5192","lrigolo@bwh.harvard.edu",{"name":88,"role":97},"PRINCIPAL_INVESTIGATOR",{"lat":99,"lon":100},42.35843,-71.05977,[102,103],{"name":88,"role":89,"phone":90,"email":91},{"name":93,"role":89,"phone":94,"email":95},[105],{"name":88,"affiliation":13,"role":97},[107,111,114,117,120,123,126,129,132,135,138,141],{"pmid":108,"type":109,"citation":110},"15016991","BACKGROUND","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\u002Fscience.1089506.",{"pmid":112,"type":109,"citation":113},"20004608","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\u002Fj.tics.2009.10.011. Epub 2009 Dec 11.",{"pmid":115,"type":109,"citation":116},"28860215","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\u002Fajnr.A5345. Epub 2017 Aug 31.",{"pmid":118,"type":109,"citation":119},"26663615","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\u002Fhbm.23075. Epub 2015 Dec 10.",{"pmid":121,"type":109,"citation":122},"25962953","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\u002Fjon.12251. Epub 2015 May 12.",{"pmid":124,"type":109,"citation":125},"21435578","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\u002Fj.nec.2011.01.001.",{"pmid":127,"type":109,"citation":128},"19018313","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\u002F1874440000802010014. Epub 2008 Apr 1.",{"pmid":130,"type":109,"citation":131},"32276065","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\u002Fj.neuroimage.2020.116828. Epub 2020 Apr 7.",{"pmid":133,"type":109,"citation":134},"34172562","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\u002Fjnnp-2020-325738. Epub 2021 Jun 25. No abstract available.",{"pmid":136,"type":109,"citation":137},"30648771","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\u002Fjon.12597. Epub 2019 Jan 16.",{"pmid":139,"type":109,"citation":140},"29969491","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\u002Fjournal.pone.0200134. eCollection 2018.",{"pmid":142,"type":109,"citation":143},"17504783","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\u002Fcercor\u002Fbhm049. Epub 2007 May 15.",[],{"nct_id":4,"conditions":146,"biomarkers":147},[19],[],{"nct_id":4,"found":149,"summary":150,"prompt_version":160},true,{"design":151,"status":152,"heading":153,"summary":154,"follow_up":155,"word_count":156,"commitments":157,"compensation":158,"drugs_mentioned":159},"This is an interventional study with a planned enrollment of 90 participants. It compares two types of fMRI to see which is better for mapping brain function.","completed","Movie-Watching fMRI for Brain Tumor Patients","This study is comparing a new type of functional MRI (fMRI) called \"naturalistic viewing\" (or movie watching) with the standard fMRI used in clinics. Standard fMRI uses tasks like reading to find out which parts of your brain control language. This information helps surgeons plan brain operations. This research will see if the movie-watching fMRI works as well as, or better than, the standard method. If it does, it could make planning future surgeries easier for patients with glioma or adult brain tumors, as you wouldn't need to do multiple tasks during the scan. You can join if you are between 21 and 70 years old, speak English, have a known or suspected glioma, and are scheduled for a presurgical fMRI at BWH. The study aims to enroll 90 participants. The status of this study is currently unclear.","The study will measure language localization, lateralization, and fMRI language activations concordance with language fiber tracts from enrollment up to 6 months after brain surgery.",138,"You would participate in an additional study scan and undergo neuropsychological assessments, which are tests of your thinking and behavior.","Not stated in the trial record.",[],"v2"]