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

NCT ID: NCT04062305

Last Updated: 2026-01-14

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-09
• Study Completion Date: 2027-05-06

Brief Summary

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.

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.

Conditions

Metastatic Malignant Neoplasm in the Brain; Radiation Therapy Recipient

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Quality-of-Life Assessment

Intervention Type: OTHER

Ancillary studies

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Hand Function Test

Intervention Type: BEHAVIORAL

Complete tasks that test grip strength, pinch strength, and ability to use and feel with hands

Navigated Transcranial Magnetic Stimulation

Intervention Type: PROCEDURE

Undergo nTMS

Interventions

Quality-of-Life Assessment

Ancillary studies

Intervention Type: OTHER

Questionnaire Administration

Ancillary studies

Intervention Type: OTHER

Hand Function Test

Complete tasks that test grip strength, pinch strength, and ability to use and feel with hands

Intervention Type: BEHAVIORAL

Navigated Transcranial Magnetic Stimulation

Undergo nTMS

Intervention Type: PROCEDURE

Other Intervention Names

Hand Sensory Test; Navigated TMS; nTMS; Quality of Life Assessment

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Caroline Chung

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

M D Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Related Links

http://www.mdanderson.org

MD Anderson Cancer Center

Other Identifiers

NCI-2019-04992

Identifier Type: REGISTRY

Identifier Source: secondary_id

2019-0302

Identifier Type: OTHER

Identifier Source: secondary_id

2019-0302

Identifier Type: -

Identifier Source: org_study_id