The Use of Navigated Transcranial Magnetic Stimulation (nTMS) in the Inhibition of Neurofunctional Regions of Interest

Surgery Clinical Trial

Official title:

The Use of Navigated Transcranial Magnetic Stimulation (nTMS) in the Inhibition of Neurofunctional Regions of Interest

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04209023
• Other study ID #: 20193155
• Status: Suspended
• Phase: N/A
• Start date: December 16, 2023
• Est. completion date: June 18, 2025

Study information

• Verified date: September 2022
• Source: Neurological Associates of West Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Selected patients will undergo 1 session of TMS treatment to include a non-TMS baseline task and a TMS testing task. The baseline and the testing task are the self-same task. The baseline test demonstrates patient comprehension of instructions, as well as a baseline of task performance for comparison analysis. The TMS test will include the self-same task that may be randomized in terms of order of stimulus presentation. Each component--the baseline and the TMS task--will have a duration of 10 minutes, for a total intervention time of 20 minutes.

Individual pulses (100% motor threshold intensity, continuous temperature of 24-C) will be delivered upon the presentation of the stimulus or the verbal command for the language tasks. For the motor area, intermittent pulses will be delivered during random finger-tapping. Two research coordinators will perform the intervention, with one coordinator presenting the stimulus/giving commands, and the other positioning the TMS coil and delivering the individual pulse or pulse trains. For the language tasks, both research coordinators need to be well-harmonized: as one coordinator presents the stimulus, the other must simultaneously administer the pulse. The stimulus presentation will last for a duration of 1 second, in conjunction with the time-course of the pulse's disruption. One or both research coordinators must track the successful or unsuccessful inhibition of task completion for each trial. For example, if the patient was able to correctly name all but one picture during TMS, then task inhibition occurred in 1 out of 20 trials, suggesting a failure in the neuronavigation of Broca's area. The number of trials may vary depending on task and region-of-interest; however the intervention is not to exceed a total of 20 minutes. Upon conclusion of the TMS session, the patient will discuss the outcome with the treating physician and follow-on procedures will be scheduled. Patients will not need to undergo a post-treatment MRI, as the MRI scans are functioning as a technique for neuronavigation for precise targeting.

The safety of this protocol will be closely monitored and data will be used to determine whether any significant safety issues exist when using TMS therapy. Adverse events will be noted whenever they occur but will be recorded at the time of the TMS procedure.

All patients will have a thorough discussion to obtain informed consent. Additional meetings with the physicians will further clarify the nature of the study, reasons for transcranial magnetic stimulation, and the possible risks involved. The nature of this study does not require randomization, but rather attempts to isolate adverse and advantageous events should they occur.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 10
• Est. completion date: June 18, 2025
• Est. primary completion date: December 18, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Tumor
• Surgery

Intervention

Device:
• Transcranial Magnetic Stimulation
Individual pulses (100% motor threshold intensity, continuous temperature of 24 degrees C) will be delivered upon the presentation of the stimulus or the verbal command for the language tasks. Two research coordinators will perform the intervention, with one coordinator presenting the stimulus/giving commands, and the other positioning the TMS coil and delivering the individual pulse or pulse trains. The stimulus presentation will last for a duration of 1 second, in conjunction with the time-course of the pulse's disruption. One or both research coordinators must track the successful or unsuccessful inhibition of task completion for each trial. The number of trials may vary depending on task and region-of-interest; however the intervention is not to exceed a total of 20 minutes.

Locations

Country	Name	City	State
United States	Neurological Associates of West Los Angeles	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Neurological Associates of West Los Angeles

Country where clinical trial is conducted

United States, 

References & Publications (7)

Cordes 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. — View Citation

Kannurpatti 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. — View Citation

Kim 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. — View Citation

Miller 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. — View Citation

Rossini PM, Barker AT, Berardelli A, Caramia MD, Caruso G, Cracco RQ, Dimitrijevic MR, Hallett M, Katayama Y, Lücking 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. Review. — View Citation

Ugurbil K, Toth L, Kim DS. How accurate is magnetic resonance imaging of brain function? Trends Neurosci. 2003 Feb;26(2):108-14. Review. — View Citation

Walsh V, Cowey A. Transcranial magnetic stimulation and cognitive neuroscience. Nat Rev Neurosci. 2000 Oct;1(1):73-9. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TEST FOR BROCA'S AREA (ONLY): Confrontation Naming Task	A slideshow of common pictures will be presented one by one; this 20 minute task will establish baseline performance and comprehension of instructions.	Baseline prior to TMS administration
Primary	TEST FOR BROCA'S AREA (ONLY): Confrontation Naming Task	A slideshow of common pictures will be presented one by one.	Testing during TMS administration
Primary	TEST FOR WERNICKE'S AREA (ONLY): Testing Compliance to Verbalized Commands	The following verbal instructions will be given to establish baseline performance and comprehension of instructions: "When I say "tongue", stick out your tongue. Do you understand the instructions?" (Receive verbal confirmation of comprehension) "Tongue." "When I say hand, raise your hand. Do you understand the instructions?" (Receive verbal confirmation of comprehension) "Hand." "When I say foot, lift your foot. Do you understand the instructions?" (Receive verbal confirmation of comprehension) "Foot.; *repeat for duration of baseline test*	Baseline prior to TMS administration
Primary	TEST FOR WERNICKE'S AREA (ONLY): Testing Compliance to Verbalized Commands	The following verbal instructions will be given during the test phase; Upon each command, a pulse will be delivered.; "Tongue." (pulse delivered) "Hand." (pulse delivered) "Tongue." (pulse delivered) "Tongue." (pulse delivered) "Foot." (pulse delivered) "Hand." (pulse delivered) "Foot." (pulse delivered); *repeat for duration of TMS test*	Testing during TMS administration
Primary	TEST FOR MOTOR AREA (ONLY): Testing for Finger Tapping Inhibition	(A brief baseline measure (30 seconds) for patient to randomly tap fingers wherein no pulses are delivered).	Testing during TMS administration