Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04209023
Recruitment Status : Enrolling by invitation
First Posted : December 23, 2019
Last Update Posted : January 30, 2020
Sponsor:
Information provided by (Responsible Party):
Neurological Associates of West Los Angeles

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.

Condition or disease Intervention/treatment Phase
Brain Tumor Surgery Device: Transcranial Magnetic Stimulation Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: The Use of Navigated Transcranial Magnetic Stimulation (nTMS) in the Inhibition of Neurofunctional Regions of Interest
Actual Study Start Date : December 18, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: navigated TMS
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
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.




Primary Outcome Measures :
  1. TEST FOR BROCA'S AREA (ONLY): Confrontation Naming Task [ Time Frame: Baseline prior to TMS administration ]
    A slideshow of common pictures will be presented one by one; this 20 minute task will establish baseline performance and comprehension of instructions.

  2. TEST FOR BROCA'S AREA (ONLY): Confrontation Naming Task [ Time Frame: Testing during TMS administration ]
    A slideshow of common pictures will be presented one by one.

  3. TEST FOR WERNICKE'S AREA (ONLY): Testing Compliance to Verbalized Commands [ Time Frame: Baseline prior to TMS administration ]

    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*


  4. TEST FOR WERNICKE'S AREA (ONLY): Testing Compliance to Verbalized Commands [ Time Frame: Testing during TMS administration ]

    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*


  5. TEST FOR MOTOR AREA (ONLY): Testing for Finger Tapping Inhibition [ Time Frame: Testing during TMS administration ]
    (A brief baseline measure (30 seconds) for patient to randomly tap fingers wherein no pulses are delivered).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04209023


Locations
Layout table for location information
United States, California
Neurological Associates of West Los Angeles
Los Angeles, California, United States, 90024
Sponsors and Collaborators
Neurological Associates of West Los Angeles
Investigators
Layout table for investigator information
Principal Investigator: Sheldon Jordan, MD The Neurological Associates of West Los Angeles

Publications:

Layout table for additonal information
Responsible Party: Neurological Associates of West Los Angeles
ClinicalTrials.gov Identifier: NCT04209023    
Other Study ID Numbers: 20193155
First Posted: December 23, 2019    Key Record Dates
Last Update Posted: January 30, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: 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.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Neurological Associates of West Los Angeles:
glioma
transcranial magnetic stimulation
neurofunctional inhibition
fMRI verification
Additional relevant MeSH terms:
Layout table for MeSH terms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases