What side effects are associated with this type of intervention?

The most common treatments for brain metastasis, such as stereotactic radiosurgery (SRS) and adjuvant radiotherapy, can have several side effects. These include fatigue, headaches, nausea, and potential cognitive decline. Specific to SRS, there is a risk of radiation necrosis, which can lead to symptoms like headaches, nausea, and neurological deficits. Integrating nTMS in treatment planning aims to minimize damage to the motor cortex, potentially reducing the risk of motor deficits. However, the overall side effects remain similar to those of traditional radiotherapy approaches.

What prior FDA approvals exist?

FDA-approved treatments for brain metastasis include various forms of radiation therapy such as stereotactic radiosurgery (SRS) and whole brain radiation therapy (WBRT). Systemic therapies have also been approved, particularly for specific cancer subtypes. For instance, trastuzumab and pertuzumab are approved for HER2-positive breast cancer with brain metastases. Additionally, lapatinib in combination with capecitabine has shown efficacy in treating HER2-positive brain metastases. These treatments align with the goals of nTMS trials, which aim to optimize radiation delivery while minimizing damage to critical brain areas.

What other types of research exist?

Promising alternatives to nTMS for brain metastasis patients include: 1) Laser Interstitial Thermal Therapy (LITT), which uses laser energy to ablate tumors with precision, minimizing damage to surrounding tissues. 2) Systemic therapies such as targeted therapies and immunotherapies, which have shown potential in controlling both systemic and intracranial disease, particularly in cancers like melanoma and non-small cell lung cancer. 3) Advanced radiation techniques like brachytherapy, which delivers high doses of radiation directly to the tumor while sparing surrounding brain tissue.

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Procedure

nTMS for Brain Metastasis Planning

N/A

Waitlist Available

Led By Caroline Chung

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Patient must be able to complete the Functional and Quality of Life questionnaires in English

Must not have

Significant cognitive or psychiatric symptoms that prevent the ability to complete a physical exam, questionnaires, or participate in nTMS or EMG

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial studies how well nTMS works in planning radiation therapy for patients with brain metastases in the motor cortex. nTMS maps brain areas that control muscles, helping doctors avoid damaging these critical areas during treatment. This could lead to safer and more effective radiation therapy. nTMS has been widely used for planning in brain tumor surgeries to map important areas and improve patient outcomes.

Who is the study for?

This trial is for adults with brain metastases in the motor cortex who've had stereotactic radiosurgery (SRS) 3-18 months prior. Participants must be able to undergo nTMS and EMG, have used MRI for SRS planning, and complete questionnaires in English. Excluded are those with significant cognitive/psychiatric issues or poor physical status that prevents participation.

What is being tested?

The study tests how well nTMS aids in planning stereotactic radiosurgery for patients with brain tumors affecting muscle control. It aims to map out areas of the brain responsible for movement to determine safe radiation levels without harming these critical regions.

What are the potential side effects?

nTMS is non-invasive and generally considered safe but may cause discomfort at the stimulation site, headache, lightheadedness, or seizures in very rare cases.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have brain cancer near the motor cortex and had radiation therapy 3-18 months ago.

Select...

I can complete health questionnaires in English.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I can complete physical exams and answer questions without cognitive or psychiatric issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Economic feasibility of nTMS

Identification of the motor cortex by addition of nTMS

Operational feasibility of navigated transcranial magnetic stimulation (nTMS)

+1 more

Secondary study objectives

Development of a clinical trial that will limit radiation dose to brain metastases

Presence or absence of motor deficits

Stereotactic radiosurgery (SRS) dosimetry and lesion involvement in the motor tracts

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Diagnostic (nTMS, sensory testing)Experimental Treatment4 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Navigated Transcranial Magnetic Stimulation

2019

N/A

~30

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for brain metastasis include surgery, stereotactic radiosurgery (SRS), and whole brain radiation therapy (WBRT). Surgery involves the physical removal of the tumor, which can provide immediate relief from symptoms caused by mass effect. SRS delivers high doses of targeted radiation to the tumor while sparing surrounding healthy tissue, making it effective for small to medium-sized metastases. WBRT treats the entire brain and is used for patients with multiple metastases, though it can have significant side effects. Systemic therapies, including targeted agents and immunotherapies, work by controlling both intracranial and extracranial disease. Navigated transcranial magnetic stimulation (nTMS) is used to map the motor cortex before SRS, allowing for precise radiation planning that minimizes damage to critical brain areas. This is crucial for preserving neurological function and improving the quality of life for patients with brain metastasis.

Radiotherapy in combination with systemic therapies for brain metastases: current status and progress.Optimizing Adjuvant Stereotactic Radiotherapy of Motor-Eloquent Brain Metastases: Sparing the nTMS-Defined Motor Cortex and the Hippocampus.Integrating navigated transcranial magnetic stimulation motor mapping in hypofractionated and single-dose gamma knife radiosurgery: A two-patient case series and a review of literature.