- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02165995
Use of Navigated Transcranial Magnetic Stimulation (nTMS) in Generated Motor and Language Mapping to Evaluate Brain Recovery Following Surgery
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Navigated Transcranial Magnetic Stimulation (nTMS)
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.
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pre and Post-Operative Functional Outcomes Using Navigated Transcranial Magnetic Stimulation (nTMS)
Time Frame: 12 months
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sujit Prabhu, MD, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013-0711
- NCI-2015-01905 (Registry Identifier: NCI CTRP)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Brain Tumor
-
University of California, San FranciscoGilead SciencesSuspendedBrain Cancer | Malignant Brain Tumor | Brain Tumor Adult | Recurrent Brain Tumor | Progressive Malignant Brain Tumor | Brain Tumor, PediatricUnited States
-
Xinhua Hospital, Shanghai Jiao Tong University...CNOG-MC001 Collaborative GroupCompletedPediatric Brain Tumor | Malignant Brain Tumor | Tumors, Central Nervous System | Benign Brain TumorChina
-
University of Erlangen-Nürnberg Medical SchoolNot yet recruitingBrain Tumor, Primary | Brain Tumor - MetastaticGermany
-
Technical University of MunichRecruiting
-
GT Medical Technologies, Inc.RecruitingBrain Tumor | Brain Tumor, Recurrent | Brain Tumor, Primary | Brain Tumor - Metastatic | Brain Tumor, Adult: Glioblastoma | Brain Tumor, Adult MeningiomaUnited States
-
Washington University School of MedicineNot yet recruitingBrain Tumor, PrimaryUnited States
-
University of NebraskaRecruitingPrimary Brain Tumor | Metastatic Brain TumorUnited States
-
The Hospital for Sick ChildrenPediatric Oncology Group of OntarioCompletedChildhood Brain TumorCanada
-
Ohio State University Comprehensive Cancer CenterCompletedAdult Brain TumorUnited States
-
Lawson Health Research InstituteCompletedBrain Tumor | Brain Neoplasm | Tumor, Brain | Neoplasm, Supratentorial | Tumor, SupratentorialCanada
Clinical Trials on Motor Mapping
-
Beth Israel Deaconess Medical CenterBoston UniversityCompleted
-
Erasmus Medical CenterMassachusetts General Hospital; Universitaire Ziekenhuizen KU Leuven; University... and other collaboratorsRecruitingGlioblastoma | Brain Neoplasms | Recurrent Glioblastoma | Recurrent Adult Brain Tumor | Glioblastoma, IDH-wildtype | Glioblastoma Multiforme of Brain | Brain Neoplasms, Adult, Malignant | Astrocytoma, Malignant | Brain Neoplasms, AdultUnited States, Germany, Switzerland, Belgium, Netherlands
-
Arizona State UniversityNational Institute on Deafness and Other Communication Disorders (NIDCD)RecruitingHealthy AdultsUnited States
-
Cardiovascular Research Society, GreeceJohns Hopkins UniversityNot yet recruitingTachycardia, Atrioventricular Nodal Reentry
-
University Hospital Southampton NHS Foundation...Boston Scientific Corporation; AbbottRecruiting
-
University of North Carolina, Chapel HillNational Institute on Deafness and Other Communication Disorders (NIDCD)Recruiting
-
Stephen PovoskiCompletedInvasive Breast CancerUnited States
-
Barts & The London NHS TrustCompletedAtrial TachycardiaUnited Kingdom
-
Barts & The London NHS TrustCompletedAtrial FibrillationUnited Kingdom
-
Henry Ford Health SystemWellsense USA Inc.Completed