Clinical trial · Interventional
The Use of Navigated Transcranial Magnetic Stimulation (nTMS) in the Inhibition of Neurofunctional Regions of Interest
NCT04209023CI-TRIAL-00061077suspendedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Pending end of COVID-19 pandemic
Summary
Brief summary (as posted)
The purpose of this study is to investigate the efficacy of task inhibition during TMS to confirm brain region localization. This study could provide an effective pathway for neurofunctional landmark confirmation that may be useful in a number of treatment modalities and medical considerations.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Tumor | Brain Neoplasm | ALIAS | 0.90 |
| Surgery | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Transcranial Magnetic Stimulation | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- navigated TMS
- description
- All patients are required to have an advanced MRI of the brain including a structural T1, volume measurements of various brain regions, ASL, and BOLD sequences. Patients will also undergo an in-scanner task designed to activate key neurofunctional regions of interest; these areas will provide the cerebral coordinates to be validated by TMS.
- interventionNames
- Device: Transcranial Magnetic Stimulation
Primary outcomes (5)
- measure
- TEST FOR BROCA'S AREA (ONLY): Confrontation Naming Task
- timeFrame
- Baseline prior to TMS administration
- description
- A slideshow of common pictures will be presented one by one; this 20 minute task will establish baseline performance and comprehension of instructions.
- measure
- TEST FOR BROCA'S AREA (ONLY): Confrontation Naming Task
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Indicated need for neuronavigated TMS (e.g. in the case of surgical resection of tumors affecting functional areas such as Broca's, Wenicke's, or motor cortex) which may be optimized by confirmation of specified brain regions using TMS. * At least 18 years of age * Must be willing to comply with the study protocol * English Proficiency Exclusion Criteria: * Not English Proficient * Advanced stages of any terminal illness or any active cancer that requires chemotherapy * History of epilepsy or seizure, or history of such in first degree relative * An increased risk of seizure for any reason * Stents in the neck or brain * Aneurysm clips or coils * Metal devices/objects in or near the head * Metallic implants near the ears and eyes * Facial tattoos with metallic or magnetic-sensitive ink * Hepatic impairment * Significant cytopenia * Cardiovascular, cerebrovascular, and peripheral vascular arterial thrombosis * Neurodegenerative diseases * Myeloproliferative disorders * Women who are pregnant, may become pregnant, or are breastfeeding * Subjects unable to give informed consent or in vulnerable categories, such as prisoners
References
Publications (7)
- BACKGROUNDCordes D, Haughton VM, Arfanakis K, Wendt GJ, Turski PA, Moritz CH, Quigley MA, Meyerand ME. Mapping functionally related regions of brain with functional connectivity MR imaging. AJNR Am J Neuroradiol. 2000 Oct;21(9):1636-44. PMID 11039342
- BACKGROUNDKannurpatti SS, Rypma B, Biswal BB. Prediction of Task-Related BOLD fMRI with Amplitude Signatures of Resting-State fMRI. Front Syst Neurosci. 2012 Mar 6;6:7. doi: 10.3389/fnsys.2012.00007. eCollection 2012. PMID 22408609
- BACKGROUNDKim CH, Kim JH, Chung CK, Kim JS, Lee JM, Lee SK. Localization of Broca's Area Using Functional MR Imaging: Quantitative Evaluation of Paradigms. J Korean Neurosurg Soc. 2009 Apr;45(4):219-23. doi: 10.3340/jkns.2009.45.4.219. Epub 2009 Apr 30. PMID 19444347
- BACKGROUNDMiller GA, Crocker LD, Spielberg JM, Infantolino ZP, Heller W. Issues in localization of brain function: The case of lateralized frontal cortex in cognition, emotion, and psychopathology. Front Integr Neurosci. 2013 Jan 30;7:2. doi: 10.3389/fnint.2013.00002. eCollection 2013. PMID 23386814
- BACKGROUNDRossini PM, Barker AT, Berardelli A, Caramia MD, Caruso G, Cracco RQ, Dimitrijevic MR, Hallett M, Katayama Y, Lucking CH, et al. Non-invasive electrical and magnetic stimulation of the brain, spinal cord and roots: basic principles and procedures for routine clinical application. Report of an IFCN committee. Electroencephalogr Clin Neurophysiol. 1994 Aug;91(2):79-92. doi: 10.1016/0013-4694(94)90029-9. No abstract available. PMID 7519144
- BACKGROUNDUgurbil K, Toth L, Kim DS. How accurate is magnetic resonance imaging of brain function? Trends Neurosci. 2003 Feb;26(2):108-14. doi: 10.1016/S0166-2236(02)00039-5. PMID 12536134
- BACKGROUNDWalsh V, Cowey A. Transcranial magnetic stimulation and cognitive neuroscience. Nat Rev Neurosci. 2000 Oct;1(1):73-9. doi: 10.1038/35036239.