nTMS for Brain Metastasis Planning

Overseen By Caroline Chung

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Cognitive symptoms, Psychiatric symptoms, Poor performance, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

22 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Caroline Chung

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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.

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

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

Treatment Details

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.

Participant Groups

Group I: Diagnostic (nTMS, sensory testing) Experimental Treatment 4 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.

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

Approved in European Union as Stereotactic Radiosurgery for:

• Brain tumors
• Metastatic brain tumors
• Arteriovenous malformations (AVMs)
• Trigeminal neuralgia
• Acoustic neuromas

Approved in United States as Stereotactic Radiosurgery for:

• Brain tumors
• Metastatic brain tumors
• Arteriovenous malformations (AVMs)
• Trigeminal neuralgia
• Acoustic neuromas
• Liver tumors
• Lung tumors
• Spinal cord tumors

Approved in Canada as Stereotactic Radiosurgery for:

• Brain tumors
• Metastatic brain tumors
• Arteriovenous malformations (AVMs)
• Trigeminal neuralgia
• Acoustic neuromas

Approved in Japan as Stereotactic Radiosurgery for:

• Brain tumors
• Metastatic brain tumors
• Arteriovenous malformations (AVMs)
• Trigeminal neuralgia
• Acoustic neuromas

Approved in China as Stereotactic Radiosurgery for:

• Brain tumors
• Metastatic brain tumors
• Arteriovenous malformations (AVMs)
• Trigeminal neuralgia
• Acoustic neuromas

Approved in Switzerland as Stereotactic Radiosurgery for:

• Brain tumors
• Metastatic brain tumors
• Arteriovenous malformations (AVMs)
• Trigeminal neuralgia
• Acoustic neuromas

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+