nTMS in Planning Stereotactic Radiosurgery in Patients With Brain Metastases in the Motor Cortex (NCT04062305) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
nTMS in Planning Stereotactic Radiosurgery in Patients With Brain Metastases in the Motor Cortex
United States22 participantsStarted 2019-09-09
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Operational feasibility of navigated transcranial magnetic stimulation (nTMS)
Timeframe: Up to 1 year
2
Technical feasibility of nTMS
Timeframe: Up to 1 year
3
Economic feasibility of nTMS
Timeframe: Up to 1 year
4
Identification of the motor cortex by addition of nTMS