Clinical trial NCT04209023: The Use of Navigated Transcranial Magnetic Stimulation (nTMS) in the Inhibition of Neurofunctional Regions of Interest
Official title: The Use of Navigated Transcranial Magnetic Stimulation (nTMS) in the Inhibition of Neurofunctional Regions of Interest
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Brain Tumor
Surgery
Keywords: glioma
transcranial magnetic stimulation
neurofunctional inhibition
fMRI verification
Lead sponsor: Neurological Associates of West Los Angeles
Sponsor class: OTHER
First posted: 2019-12-23
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model 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.
Primary purpose: DEVICE_FEASIBILITY

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: TEST FOR BROCA'S AREA (ONLY): Confrontation Naming Task
timeFrame: Baseline prior to TMS administration
measure: TEST FOR BROCA'S AREA (ONLY): Confrontation Naming Task
timeFrame: Testing during TMS administration
measure: TEST FOR WERNICKE'S AREA (ONLY): Testing Compliance to Verbalized Commands
timeFrame: Baseline prior to TMS administration
measure: TEST FOR WERNICKE'S AREA (ONLY): Testing Compliance to Verbalized Commands
timeFrame: Testing during TMS administration
measure: TEST FOR MOTOR AREA (ONLY): Testing for Finger Tapping Inhibition
timeFrame: Testing during TMS administration
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Neurological Associates of West Los Angeles
state: California
Study officials:
affiliation: The Neurological Associates of West Los Angeles
name: Sheldon Jordan, MD
role: PRINCIPAL_INVESTIGATOR
References:
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