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

NCT04209023 | Suspended FDA Device

• 1 other identifier: 20193155
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Brain Tumor; Surgery

Keywords

glioma; transcranial magnetic stimulation; neurofunctional inhibition; fMRI verification

Outcome Measures

Primary Outcomes (5)

• 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

• TEST FOR BROCA'S AREA (ONLY): Confrontation Naming Task

  A slideshow of common pictures will be presented one by one.

  Testing during TMS administration

• 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

• 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

• 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

Study Arms (1)

navigated TMS

EXPERIMENTAL

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.

Device: Transcranial Magnetic Stimulation

Interventions

Transcranial Magnetic Stimulation DEVICE

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.

navigated TMS

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Neurological Associates of West Los Angeles: lead

Study Sites (1)

Neurological Associates of West Los Angeles

Los Angeles, California, 90024, United States

Location

Related 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.

  PMID: 11039342 BACKGROUND

• 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.

  PMID: 22408609 BACKGROUND

• 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.

  PMID: 19444347 BACKGROUND

• 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.

  PMID: 23386814 BACKGROUND

• Rossini 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 BACKGROUND

• Ugurbil 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 BACKGROUND

• Walsh V, Cowey A. Transcranial magnetic stimulation and cognitive neuroscience. Nat Rev Neurosci. 2000 Oct;1(1):73-9. doi: 10.1038/35036239.

  PMID: 11252771 BACKGROUND

MeSH Terms

Conditions

Brain Neoplasms; Glioma

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Sheldon Jordan, MD

  The Neurological Associates of West Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 19, 2019
• First Posted: December 23, 2019
• Study Start: December 16, 2023
• Primary Completion: December 18, 2024
• Study Completion: June 18, 2025
• Last Updated: September 28, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)