Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05222594
Other study ID # 2020P001989
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 2, 2021
Est. completion date March 31, 2026

Study information

Verified date February 2024
Source Massachusetts General Hospital
Contact Evelina Fedorenko, PhD
Phone 617-258-0670
Email evelina9@mit.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Language is a signature human cognitive skill, but the precise computations that support language understanding remain unknown. This study aims to combine high-quality human neural data obtained through intracranial recordings with advances in computational modeling of human cognition to shed light on the construction and understanding of speech.


Description:

The neural architecture of language is the foundation for the highest form of human interaction. Prior work has identified a network of frontal and temporal brain areas that selectively support language processing, but the precise computations that underlie our ability to extract meaning from sequences of words have remained unknown. The standard approaches in human cognitive neuroscience lack the spatial and temporal resolution necessary for precise comparisons to computational models. To bridge this gap in knowledge, neural responses to language stimuli will be collected from epileptic patients undergoing intracranial monitoring. Overall, these data will be used to identify cortical maps of different linguistic manipulations and to better understand properties of the human language network.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date March 31, 2026
Est. primary completion date March 31, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: - clinical indications to proceed with intracranial monitoring involving the left cerebral hemisphere, as determined by a multidisciplinary epilepsy surgery team - the ability to comply with test directions and provide informed consent - between ages 18 - 85 Exclusion Criteria: - inability to understand or perform the task outlined in the protocol, or who are unwilling or unable to participate

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Behavioral tasks during intracranial monitoring
Participants will listen to sentences and stories while neural data are recorded through electrodes placed for clinical purposes.

Locations

Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Massachusetts General Hospital Massachusetts Institute of Technology

Country where clinical trial is conducted

United States, 

References & Publications (14)

Blank I, Balewski Z, Mahowald K, Fedorenko E. Syntactic processing is distributed across the language system. Neuroimage. 2016 Feb 15;127:307-323. doi: 10.1016/j.neuroimage.2015.11.069. Epub 2015 Dec 5. — View Citation

Blank IA, Fedorenko E. No evidence for differences among language regions in their temporal receptive windows. Neuroimage. 2020 Oct 1;219:116925. doi: 10.1016/j.neuroimage.2020.116925. Epub 2020 May 11. — View Citation

Fedorenko E, Behr MK, Kanwisher N. Functional specificity for high-level linguistic processing in the human brain. Proc Natl Acad Sci U S A. 2011 Sep 27;108(39):16428-33. doi: 10.1073/pnas.1112937108. Epub 2011 Sep 1. — View Citation

Fedorenko E, Blank IA. Broca's Area Is Not a Natural Kind. Trends Cogn Sci. 2020 Apr;24(4):270-284. doi: 10.1016/j.tics.2020.01.001. Epub 2020 Feb 20. — View Citation

Fedorenko E, Duncan J, Kanwisher N. Language-selective and domain-general regions lie side by side within Broca's area. Curr Biol. 2012 Nov 6;22(21):2059-62. doi: 10.1016/j.cub.2012.09.011. Epub 2012 Oct 11. — View Citation

Fedorenko E, Hsieh PJ, Nieto-Castanon A, Whitfield-Gabrieli S, Kanwisher N. New method for fMRI investigations of language: defining ROIs functionally in individual subjects. J Neurophysiol. 2010 Aug;104(2):1177-94. doi: 10.1152/jn.00032.2010. Epub 2010 Apr 21. — View Citation

Fedorenko E, Nieto-Castanon A, Kanwisher N. Lexical and syntactic representations in the brain: an fMRI investigation with multi-voxel pattern analyses. Neuropsychologia. 2012 Mar;50(4):499-513. doi: 10.1016/j.neuropsychologia.2011.09.014. Epub 2011 Sep 17. — View Citation

Fedorenko E, Scott TL, Brunner P, Coon WG, Pritchett B, Schalk G, Kanwisher N. Neural correlate of the construction of sentence meaning. Proc Natl Acad Sci U S A. 2016 Oct 11;113(41):E6256-E6262. doi: 10.1073/pnas.1612132113. Epub 2016 Sep 26. — View Citation

Mollica F, Siegelman M, Diachek E, Piantadosi ST, Mineroff Z, Futrell R, Kean H, Qian P, Fedorenko E. Composition is the Core Driver of the Language-selective Network. Neurobiol Lang (Camb). 2020 Mar 1;1(1):104-134. doi: 10.1162/nol_a_00005. eCollection 2020. — View Citation

Nieto-Castanon A, Fedorenko E. Subject-specific functional localizers increase sensitivity and functional resolution of multi-subject analyses. Neuroimage. 2012 Nov 15;63(3):1646-69. doi: 10.1016/j.neuroimage.2012.06.065. Epub 2012 Jul 8. — View Citation

Norman-Haignere S, Kanwisher NG, McDermott JH. Distinct Cortical Pathways for Music and Speech Revealed by Hypothesis-Free Voxel Decomposition. Neuron. 2015 Dec 16;88(6):1281-1296. doi: 10.1016/j.neuron.2015.11.035. — View Citation

Pereira F, Lou B, Pritchett B, Ritter S, Gershman SJ, Kanwisher N, Botvinick M, Fedorenko E. Toward a universal decoder of linguistic meaning from brain activation. Nat Commun. 2018 Mar 6;9(1):963. doi: 10.1038/s41467-018-03068-4. — View Citation

Shain C, Blank IA, van Schijndel M, Schuler W, Fedorenko E. fMRI reveals language-specific predictive coding during naturalistic sentence comprehension. Neuropsychologia. 2020 Feb 17;138:107307. doi: 10.1016/j.neuropsychologia.2019.107307. Epub 2019 Dec 24. — View Citation

Siegelman M, Blank IA, Mineroff Z, Fedorenko E. An Attempt to Conceptually Replicate the Dissociation between Syntax and Semantics during Sentence Comprehension. Neuroscience. 2019 Aug 10;413:219-229. doi: 10.1016/j.neuroscience.2019.06.003. Epub 2019 Jun 11. — View Citation

* Note: There are 14 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Cortical maps of linguistic responses By using sEEG intracranial recordings of the brain, EEG power in frequency bands will reflect cortical maps of responses to different linguistic manipulations, informing the functional organization of the human language system. Power is measured in arbitrary units; higher power reflects greater activity at the investigated frequency. Throughout intracranial monitoring period, up to approximately 10 days
Primary Neural time-courses during naturalistic language comprehension Time-courses of neural response to language across diverse parts of the language network. These data will be used to predict across-time variation in response strength from the properties of linguistic input. Throughout intracranial monitoring period, up to approximately 10 days
Primary Brain scores for diverse artificial neural network (ANN) language models Human neural data will be compared to ANN language models to test how well these models predict human responses to language and why. There are no minimum or maximum scores. Higher values mean better model predictivity (i.e., a better match between model representations and neural responses). Throughout intracranial monitoring period, up to approximately 10 days
See also
  Status Clinical Trial Phase
Completed NCT04595513 - Stopping TSC Onset and Progression 2: Epilepsy Prevention in TSC Infants Phase 1/Phase 2
Completed NCT02909387 - Adapting Project UPLIFT for Blacks in Georgia N/A
Completed NCT05552924 - Self Acupressure on Fatigue and Sleep Quality in Epilepsy Patients N/A
Terminated NCT01668654 - Long-term, Open-label Safety Extension Study of Retigabine/Ezogabine in Pediatric Subjects (>= 12 Years Old) With POS or LGS Phase 3
Not yet recruiting NCT05068323 - Impact of Interictal Epileptiform Activity on Some Cognitive Domains in Newly Diagnosed Epileptic Patients N/A
Completed NCT03994718 - Creative Arts II Study N/A
Recruiting NCT04076449 - Quantitative Susceptibility Biomarker and Brain Structural Property for Cerebral Cavernous Malformation Related Epilepsy
Completed NCT00782249 - Trial Comparing Different Stimulation Paradigms in Patients Treated With Vagus Nerve Stimulation for Refractory Epilepsy N/A
Completed NCT03683381 - App-based Intervention for Treating Insomnia Among Patients With Epilepsy N/A
Recruiting NCT05101161 - Neurofeedback Using Implanted Deep Brain Stimulation Electrodes N/A
Active, not recruiting NCT06034353 - Impact of Pharmacist-led Cognitive Behavioral Intervention on Adherence and Quality of Life of Epileptic Patients N/A
Recruiting NCT05769933 - Bridging Gaps in the Neuroimaging Puzzle: New Ways to Image Brain Anatomy and Function in Health and Disease Using Electroencephalography and 7 Tesla Magnetic Resonance Imaging
Not yet recruiting NCT06408428 - Glioma Intraoperative MicroElectroCorticoGraphy N/A
Not yet recruiting NCT05559060 - Comorbidities of Epilepsy(Cognitive and Psychiatric Dysfunction)
Completed NCT02646631 - Behavioral and Educational Tools to Improve Epilepsy Care N/A
Completed NCT02977208 - Impact of Polymorphisms of OCT2 and OCTN1 on the Kinetic Disposition of Gabapentin in Patients Undergoing Chronic Use Phase 4
Completed NCT02952456 - Phenomenological Approach of Epilepsy in Patients With Epilepsy
Recruiting NCT02539134 - TAK-935 Multiple Rising Dose Study in Healthy Participants Phase 1
Completed NCT02491073 - Study to Evaluate Serum Free Thyroxine (FT4) and Free Triiodothyronine (FT3) Measurements for Subjects Treated With Eslicarbazeine Acetate (ESL) N/A
Terminated NCT02757547 - Transcranial Magnetic Stimulation for Epilepsy N/A