Use of Navigated Transcranial Magnetic Stimulation (nTMS) in Generated Motor and Language Mapping to Evaluate Brain Recovery Following Surgery
Primary Purpose
Brain Tumor
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Motor Mapping
Speech Mapping
Sponsored by
About this trial
This is an interventional treatment trial for Brain Tumor focused on measuring Brain Tumor, Glioma, Tumor resection, Navigated Transcranial Magnetic Stimulation, nTMS, Brain mapping, Motor function, Speech function, Speech mapping
Eligibility Criteria
Inclusion Criteria:
- Patients with a new or recurrent, presumed or documented, diagnosis of primary or secondary brain tumor in or adjacent to eloquent brain areas (motor, SMA and language) who are scheduled to undergo tumor resection.
- Patients must sign an informed consent.
Exclusion Criteria:
- Patients with a history of uncontrolled seizures
- Patients with metal implant or a cardiac pacemaker
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Navigated Transcranial Magnetic Stimulation (nTMS)
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02165995
First Posted
June 11, 2014
Last Updated
December 28, 2016
Sponsor
M.D. Anderson Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT02165995
Brief Title
Use of Navigated Transcranial Magnetic Stimulation (nTMS) in Generated Motor and Language Mapping to Evaluate Brain Recovery Following Surgery
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Withdrawn
Study Start Date
September 2014 (undefined)
Primary Completion Date
September 2018 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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 20 participants will be enrolled in this study. All will take part at MD Anderson.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Tumor
Keywords
Brain Tumor, Glioma, Tumor resection, Navigated Transcranial Magnetic Stimulation, nTMS, Brain mapping, Motor function, Speech function, Speech mapping
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Navigated Transcranial Magnetic Stimulation (nTMS)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Motor Mapping
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Speech Mapping
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pre and Post-Operative Functional Outcomes Using Navigated Transcranial Magnetic Stimulation (nTMS)
Description
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.
Time Frame
12 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with a new or recurrent, presumed or documented, diagnosis of primary or secondary brain tumor in or adjacent to eloquent brain areas (motor, SMA and language) who are scheduled to undergo tumor resection.
Patients must sign an informed consent.
Exclusion Criteria:
Patients with a history of uncontrolled seizures
Patients with metal implant or a cardiac pacemaker
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sujit Prabhu, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Links:
URL
http://www.mdanderson.org
Description
University of Texas MD Anderson Cancer Center Website
Learn more about this trial
Use of Navigated Transcranial Magnetic Stimulation (nTMS) in Generated Motor and Language Mapping to Evaluate Brain Recovery Following Surgery
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