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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Withdrawn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
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

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

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 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.
  2. Patients must sign an informed consent.

Exclusion Criteria:

  1. Patients with a history of uncontrolled seizures
  2. 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

    First Posted
    June 11, 2014
    Last Updated
    December 28, 2016
    Sponsor
    M.D. Anderson Cancer Center
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    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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