Brain Tumor Clinical Trial
Official title:
Use of Navigated Transcranial Magnetic Stimulation (nTMS) in Generated Motor and Language Mapping to Evaluate Brain Recovery and Plasticity Following Brain Tumor Surgery in or Adjacent to Eloquent Cortex
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 tumor in areas of
the brain that control movement (motor function) and/or speech.
nTMS is a system designed to map the brain's function relating to movement and speech.
If you agree to take part in this study, you will be assessed by the nTMS system before
surgery and then at the same time as your routine follow-up visits, about 1, 3, 6, and 12
months after surgery.
At each visit, the following will occur:
- For motor mapping, pads to monitor your movements will be placed on your face, arms and
legs. A coil that is used to deliver stimulation will be placed on your head. During
stimulation, you will be asked to move certain muscles and will be monitored for motor
responses over the course of 20 to 30 minutes. You may feel a mild tingling sensation
in your arms and/or legs during stimulation.
- For speech mapping, you will be shown 95 black-and-white drawings of common objects and
asked to name them. During stimulation, you will be asked to name the objects again and
will be monitored for changes in speech or delays. You may feel a mild tingling
sensation and contraction of the muscles in the face during stimulation. This should
take about 1½-2 hours to complete.
You will sign a separate consent form that describes the surgery you will have and its risks
in more detail. Information collected during surgery will be compared to nTMS information
collected before and after surgery.
Your nTMS data, health information from your routine physical exams, and data about your
motor and speech function collected during surgery will be analyzed by researchers. Basic
information (such as your age, sex, and race) will also be collected from your medical
record.
Length of Study:
Your participation in this study will be over after your last (12-month) study visit.
This is an investigational study. The nTMS system is FDA approved to map the brain's
function relating to movement and speech. Using the nTMS system before and after surgery to
check movement and speech function in patients with brain tumors in these areas is
investigational.
Up to 20 participants will be enrolled in this study. All will take part at MD Anderson.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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