22 Participants Needed

nTMS for Brain Metastasis Planning

CC
Overseen ByCaroline Chung
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: M.D. Anderson Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 6 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how well nTMS (Navigated Transcranial Magnetic Stimulation) can assist in planning radiation treatment for individuals with brain metastases affecting the motor cortex, which controls muscle movement. Stereotactic radiosurgery delivers high radiation doses to combat cancer but may harm nearby brain areas. nTMS could enable doctors to target radiation more precisely, safeguarding critical muscle-control regions. The trial includes participants who have undergone radiation treatment for brain metastases in the past 3-18 months and can engage in nTMS and muscle testing. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance future treatment precision.

What prior data suggests that nTMS is safe for planning stereotactic radiosurgery?

Research has shown that navigated transcranial magnetic stimulation (nTMS) is generally safe and well-tolerated. In a study with 733 patients, nTMS mapping used before surgery did not cause any serious side effects. This non-invasive technique does not involve surgery or entering the body.

nTMS works by using sensors on muscles to locate the exact brain area controlling those muscles, aiding doctors in planning treatments more accurately. Other studies have also demonstrated that nTMS can be safely used for brain mapping during surgeries. Reports of negative effects were very few, indicating that it is a reliable and low-risk tool.12345

Why are researchers excited about this trial?

Researchers are excited about using navigated Transcranial Magnetic Stimulation (nTMS) for planning stereotactic radiosurgery in brain metastasis patients because it offers a non-invasive way to map brain function. Unlike traditional imaging techniques, nTMS can precisely identify critical areas of the brain involved in motor and sensory functions, potentially enhancing the accuracy of treatment planning. This method could lead to fewer side effects and better preservation of brain function compared to existing options. By integrating sensory and motor testing, nTMS aims to provide a more comprehensive understanding of each patient's brain, which could personalize and improve the outcomes of radiosurgery treatments.

What evidence suggests that nTMS is effective for planning stereotactic radiosurgery in patients with brain metastases?

Research has shown that navigated Transcranial Magnetic Stimulation (nTMS) effectively maps the brain's motor cortex, which controls muscle movement. This technique helps doctors identify precise brain areas to avoid during surgery or radiation treatment, reducing the risk of damaging critical parts. Studies have demonstrated that nTMS can accurately guide brain surgeries by pinpointing areas to protect, especially in patients with brain tumors. In this trial, participants will undergo nTMS as part of the diagnostic arm to assess its utility in planning stereotactic radiosurgery, a type of radiation treatment. This approach aims to minimize harm to the motor cortex. While more research is needed, early results are promising for its use in planning treatment for brain metastases.14678

Who Is on the Research Team?

Caroline Chung | MD Anderson Cancer Center

Caroline Chung

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have brain cancer near the motor cortex and had radiation therapy 3-18 months ago.
I can complete health questionnaires in English.
You must be able to take part in tests that stimulate both sides of your brain's motor areas.
See 2 more

Exclusion Criteria

I can complete physical exams and answer questions without cognitive or psychiatric issues.
I struggle with daily activities due to my health condition.
I have not had treatments that affect my thinking, mood, or movement.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Diagnostic

Patients undergo nTMS and perform tasks testing grip and pinch strength

1 hour
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after diagnostic procedures

Up to 1 year

What Are the Treatments Tested in This Trial?

Interventions

  • Navigated Transcranial Magnetic Stimulation
  • Stereotactic Radiosurgery
Trial Overview 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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Diagnostic (nTMS, sensory testing)Experimental Treatment4 Interventions

Stereotactic Radiosurgery is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

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Approved in European Union as Stereotactic Radiosurgery for:
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Approved in United States as Stereotactic Radiosurgery for:
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Approved in Canada as Stereotactic Radiosurgery for:
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Approved in Japan as Stereotactic Radiosurgery for:
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Approved in China as Stereotactic Radiosurgery for:
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Approved in Switzerland as Stereotactic Radiosurgery for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Citations

The Role of Navigated Transcranial Magnetic Stimulation ...For patients with single, large brain metastases, surgery followed by external-beam RT is considered an effective treatment strategy (4, 5). Regarding surgical ...
Use of Navigated Transcranial Magnetic Stimulation (nTMS ...The goal of this clinical research study is to learn about using Navigated Transcranial Magnetic Stimulation (nTMS) in patients having surgery to remove a brain ...
Navigated Transcranial Magnetic Stimulation Motor ...We only included studies regarding motor mapping in craniotomy for brain tumors, which reported data about CTS sparing. Results: A total of 335 ...
Navigated repetitive transcranial magnetic stimulation as ...Our findings suggest that nrTMS language mapping could be a reliable method, particularly in obtaining responses for cases without tumor-involvement.
NAVIGATED TRANSCRANIAL MAGNETIC STIMULATION ...The ideal study to determine whether nTMS improves health outcomes in patients being considered for surgical resection of brain tumors would be ...
Application of Navigated Transcranial Magnetic Stimulation ...Application of navigated transcranial magnetic stimulation (nTMS) to study the visual–spatial network and prevent neglect in brain tumour surgery.
7.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/33746895/
Navigated Transcranial Magnetic Stimulation Motor ...We found that nTMS can be defined as a safe and non-invasive technique and in association with DES, fMRI, and IONM, improves brain mapping and the extent of ...
Safety and tolerability of navigated TMS for preoperative ...This large, multicenter series describes the safety of pre-operative navigated TMS mapping in 733 neurosurgical patients.
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