nTMS in Planning Stereotactic Radiosurgery in Patients With Brain Metastases in the Motor Cortex

February 21, 2024 updated by: M.D. Anderson Cancer Center

Feasibility of Navigated Transcranial Magnetic Stimulation (nTMS) of Patients Treated With Stereotactic Radiosurgery for Brain Metastases in the Motor Cortex: A Comprehensive Cross-Sectional Assessment

This trial studies how well nTMS works in planning for stereotactic radiosurgery in patients with brain metastases in the motor cortex. Stereotactic radiosurgery is a type of radiation therapy that delivers high doses of radiation, which can sometimes lead to damage occurring to the brain and surrounding areas. The motor cortex (the part of the nervous system that controls muscle movement), however, currently has no radiation dose limit. nTMS is a non-invasive tool that uses sensors on a patient's muscle to trace the location in their brain that controls that muscle and is currently used by doctors to decide where to operate so as not to damage the motor nerves. nTMS may effectively help plan radiation treatment using SRS and help doctors decide on how much radiation can be used on motor nerves.

Study Overview

Detailed Description

PRIMARY OBJECTIVES:

I. To determine if the use of navigated transcranial magnetic stimulation (nTMS) in the radiation oncology clinic is feasible.

SECONDARY OBJECTIVES:

I. To investigate the relationship of stereotactic radiosurgery (SRS) dosimetry and lesion involvement in the motor tracts identified using nTMS and the presence or absence of motor deficits evaluated by objective and subjective measures (Manual Ability Measure [MAM]-20, Euroqol [EQ]-5 Dimensional [D]-5 Level [L], and MD Anderson Symptom Inventory [MDASI]-Brain Tumor [BT] questionnaires).

II. To determine if nTMS of contralateral motor tracts provides a viable internal control, considering handedness.

III. To aid in the design of a prospective, randomized clinical trial that will limit radiation dose to brain metastases located in close proximity to the motor cortex with the goal of improving functional and quality of life outcomes measured by occupational therapy tasks and the MAM-20, EQ-5D-5L, and MDASI-BT questionnaires.

IV. To explore the utility of electroencephalography (EEG) in correlation with nTMS and reported functional outcomes measured by occupational therapy tasks and the MAM-20, EQ-5D-5L, and MDASI-BT questionnaires.

OUTLINE:

Patients undergo nTMS over 1 hour. Patients also perform 4 tasks that test grip and pinch strength and the ability to use and feel with their hands for 1 hour.

Study Type

Interventional

Enrollment (Estimated)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • M D Anderson Cancer Center
        • Contact:
          • Caroline Chung
          • Phone Number: 713-563-2300
        • Principal Investigator:
          • Caroline Chung

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult patients with brain metastases located in or near the motor cortex who have previously received SRS to that lesion within the prior 3-18 months
  • Patients must be able to participate in nTMS of bilateral motor cortices
  • Patients must be able to participate in an electromyography (EMG)
  • Patient's must have utilized magnetic resonance imaging (MRI) for their previous SRS treatment planning
  • Patient must be able to complete the Functional and Quality of Life questionnaires in English

Exclusion Criteria:

  • Significant cognitive or psychiatric symptoms that prevent the ability to complete a physical exam, questionnaires, or participate in nTMS or EMG
  • Poor performance status Karnofsky performance score (KPS < 60) that prevents the ability to participate in a physical exam, nTMS, or EMG. Patients will not be excluded if they are not able to complete the exploratory EEG analysis
  • Patients receiving any prior treatment that might impact their cognitive, psychiatric, or motor cortex function

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diagnostic (nTMS, sensory testing)
Patients undergo nTMS over 1 hour. Patients also perform 4 tasks that test grip and pinch strength, and the ability to use and feel with their hands for 1 hour.
Ancillary studies
Other Names:
  • Quality of Life Assessment
Ancillary studies
Complete tasks that test grip strength, pinch strength, and ability to use and feel with hands
Other Names:
  • Hand Sensory Test
Undergo nTMS
Other Names:
  • Navigated TMS
  • nTMS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operational feasibility of navigated transcranial magnetic stimulation (nTMS)
Time Frame: Up to 1 year
Will be determined to be operationally feasible on a patient if the images and data obtained from nTMS for the patient provide useful information to the radiation oncologist and if the radiation oncologist determines that this additional information would improve patient care. Will deem the use of nTMS to be operationally feasible overall if it is deemed operationally feasible on an underlying proportion of at least 90% potentially consented patients. Will calculate the proportions of operational and technical feasibility of the use of nTMS and their 80% confidence intervals (CIs). If the observed proportions are greater than or equal to 82%, the use of nTMS to be operationally and technically will be deemed feasible.
Up to 1 year
Technical feasibility of nTMS
Time Frame: Up to 1 year
Will be determined to be technically feasible on a patient if the procedure of nTMS is able to be performed on the patient, resulting in mapped motor cortex data. If the patient is not able to complete the procedure for any reason, that patient's nTMS treatment will not be technically feasible. Will deem the use of nTMS to be technically feasible overall if it is deemed technically feasible on an underlying proportion of at least 90% potentially consented patients. Will calculate the proportions of operational and technical feasibility of the use of nTMS and their 80% CIs. If the observed proportions are greater than or equal to 82%, the use of nTMS to be operationally and technically will be deemed feasible.
Up to 1 year
Economic feasibility of nTMS
Time Frame: Up to 1 year
Will be determined to be economically feasible if there are no additional costs to the patients and department, other than those outlined in the proposed budget.
Up to 1 year
Identification of the motor cortex by addition of nTMS
Time Frame: Up to 1 year
The treating radiation oncologist will determine if the use of nTMS provides additional information over the standard atlas-based definition of the motor region if they state that they would have made adjustments to their treatment volume of the tumor based on the new nTMS data provided.
Up to 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stereotactic radiosurgery (SRS) dosimetry and lesion involvement in the motor tracts
Time Frame: Up to 1 year
The relationship will be identified using nTMS. Dose volume histogram data for the motor cortex and motor tracts will be generated.
Up to 1 year
Presence or absence of motor deficits
Time Frame: Up to 1 year
Will be determined by the Manual Ability Measure-20, Euroqol-5 Dimensional-5 Level, and MD Anderson Symptom Inventory - Brain Tumor questionnaires. Data analyses will be performed to determine correlations between objective/subjective deficits (based on the results of the questionnaires) and dose volume histogram data for the motor cortex and tracts.
Up to 1 year
Production of viable internal control by contralateral motor tract, accounting for handedness
Time Frame: Up to 1 year
Up to 1 year
Development of a clinical trial that will limit radiation dose to brain metastases
Time Frame: Up to 1 year
Will determine if trial can aid in the design of a prospective, randomized clinical trial that will limit radiation dose to brain metastases located in close proximity to the motor cortex with the goal of improving functional and quality of life outcomes based on meeting the primary objective of this study.
Up to 1 year
Utility of electroencephalography (EEG)
Time Frame: Up to 1 year
The utility of EEG in correlation with nTMS and reported functional outcomes will be explored.
Up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Caroline Chung, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 9, 2019

Primary Completion (Estimated)

May 6, 2025

Study Completion (Estimated)

May 6, 2025

Study Registration Dates

First Submitted

August 16, 2019

First Submitted That Met QC Criteria

August 16, 2019

First Posted (Actual)

August 20, 2019

Study Record Updates

Last Update Posted (Estimated)

February 22, 2024

Last Update Submitted That Met QC Criteria

February 21, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 2019-0302 (Other Identifier: M D Anderson Cancer Center)
  • NCI-2019-04992 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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