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Procedure
nTMS for Brain Metastasis Planning
N/A
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
Study Summary
This trial is testing whether nTMS can help plan radiation treatment for brain metastases in the motor cortex. 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. The trial will test whether nTMS can help doctors decide on how much radiation can be used on motor nerves.
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.Check my eligibility
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.See study design
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 belowSelect...
I have brain cancer near the motor cortex and had radiation therapy 3-18 months ago.
Select...
I can complete health questionnaires in English.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Economic feasibility of nTMS
Identification of the motor cortex by addition of nTMS
Operational feasibility of navigated transcranial magnetic stimulation (nTMS)
+1 moreSecondary outcome measures
Development of a clinical trial that will limit radiation dose to brain metastases
Presence or absence of motor deficits
Production of viable internal control by contralateral motor tract, accounting for handedness
+2 moreTrial 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
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,974 Previous Clinical Trials
1,789,454 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,672 Previous Clinical Trials
40,926,419 Total Patients Enrolled
Caroline ChungPrincipal InvestigatorM.D. Anderson Cancer Center
4 Previous Clinical Trials
252 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can complete physical exams and answer questions without cognitive or psychiatric issues.I have brain cancer near the motor cortex and had radiation therapy 3-18 months ago.I can complete health questionnaires in English.I struggle with daily activities due to my health condition.I have not had treatments that affect my thinking, mood, or movement.You must be able to take part in tests that stimulate both sides of your brain's motor areas.My previous radiation therapy was planned with an MRI.You must be able to undergo a test called electromyography (EMG).
Research Study Groups:
This trial has the following groups:- Group 1: Diagnostic (nTMS, sensory testing)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the recruitment process for this clinical trial ongoing?
"Affirmative. According to the information found on clinicaltrials.gov, this research is presently recruiting volunteers. The trial was originally posted in September 2019 and last updated in July 2022 with a search for 22 participants at one medical centre."
Answered by AI
What is the limit for enrollees in this clinical trial?
"Affirmative. Clinicaltrials.gov's records indicate that this clinical experiment is currently seeking participants, having been originally posted on September 9th 2019 and modified most recently on July 14th 2022. The study needs to recruit 22 people from a single site."
Answered by AI
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