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Nervous System Neoplasms

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Central Nervous System Diseases

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.

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.

Transcranial Magnetic Stimulation

Sheldon Jordan, MD

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.

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.

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.

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

Data from this study will not be made publicly available due to ethical and privacy concerns. Anonymized data will be available upon reasonable request from any qualified investigator.

A slideshow of common pictures will be presented one by one; this 20 minute task will establish baseline performance and comprehension of instructions.

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

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\*

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\*

(A brief baseline measure (30 seconds) for patient to randomly tap fingers wherein no pulses are delivered).

Spots Global Cancer Trial Database for neurofunctional inhibition