Use of Navigated Transcranial Magnetic Stimulation (nTMS) in Generated Motor and Language Mapping to Evaluate Brain Recovery Following Surgery
Conditions
Brain Tumor
Conditions: official terms
Brain Neoplasms
Conditions: Keywords
Brain Tumor, Glioma, Tumor resection, Navigated Transcranial Magnetic Stimulation, nTMS, Brain mapping, Motor function, Speech function, Speech mapping
Study Type
Interventional
Study Phase
N/A
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Motor Mapping Type: Procedure
Name: Speech Mapping Type: Procedure
Overall Status
Recruiting
Summary
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.
Detailed Description
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 21 participants will be enrolled in this study. All will take part at MD Anderson.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: N/A
Gender: Both
Criteria: Inclusion Criteria:

1) Patients with a new or recurrent, presumed or documented, diagnosis of glioma (any WHO grade) in or adjacent to eloquent brain areas (motor, SMA and language) undergoing a resection of their tumor at M. D. Anderson Cancer Center.

Exclusion Criteria:

1. Unwillingness to provide consent for study participation.

2. Presence of a metal implant or cardiac pacemaker.

3. History of uncontrolled epileptic seizures.

4. There will be no exclusion based on patient age.
Location
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Status: Recruiting
Start Date
September 2014
Sponsors
M.D. Anderson Cancer Center
Source
M.D. Anderson Cancer Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page