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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2015-01905 | Registry Identifier | NCI CTRP |
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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Navigated Transcranial Magnetic Stimulation (nTMS) | Experimental | Participant assessed by nTMS system before surgery, then again at 1, 3, 6, and 12 months following surgery. Motor mapping and speech mapping performed at these visits. This should take about 1½-2 hours to complete. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motor Mapping | Procedure | Motor mapping performed using nTMS system before surgery, then again at 1, 3, 6, and 12 months following surgery. Pads to monitor movements placed on face, arms and legs. A coil that is used to deliver stimulation will be placed on head. During stimulation, participant be asked to move certain muscles and will be monitored for motor responses over the course of 20 to 30 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Pre and Post-Operative Functional Outcomes Using Navigated Transcranial Magnetic Stimulation (nTMS) | Data obtained using nTMS correlated with data collected intraoperatively during direct electrical stimulation (DES). nTMS stimulation also correlated with neurological status and functional recovery after surgery. The Chi-square or Fisher's exact tests used to explore associations between categorical variables. T-tests, Wilcoxon rank sum tests, or regression models used for continuous variables. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sujit Prabhu, MD | M.D. Anderson Cancer Center | Principal Investigator |
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| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| D005910 | Glioma |
| D013060 | Speech |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
| Speech Mapping | Procedure | Speech mapping performed using nTMS system before surgery, then again at 1, 3, 6, and 12 months following surgery. Participant shown 95 black-and-white drawings of common objects and asked to name them. During stimulation, participant asked to name the objects again and will be monitored for changes in speech or delays. This should take about 1½-2 hours to complete. |
|
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D014705 | Verbal Behavior |
| D003142 | Communication |
| D001519 | Behavior |