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Use of Navigated Transcranial Magnetic Stimulation (nTMS) in Generated Motor and Language Mapping to Evaluate Brain Recovery Following Surgery

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ClinicalTrials.gov Identifier: NCT02165995
Recruitment Status : Withdrawn
First Posted : June 18, 2014
Last Update Posted : December 29, 2016
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.


Condition or disease Intervention/treatment Phase
Brain Tumor Procedure: Motor Mapping Procedure: Speech Mapping Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : September 2014
Estimated Primary Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors

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.
Procedure: Motor Mapping
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.

Procedure: Speech Mapping
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 Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02165995


Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
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Principal Investigator: Sujit Prabhu, MD M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02165995     History of Changes
Other Study ID Numbers: 2013-0711
NCI-2015-01905 ( Registry Identifier: NCI CTRP )
First Posted: June 18, 2014    Key Record Dates
Last Update Posted: December 29, 2016
Last Verified: December 2016

Keywords provided by M.D. Anderson Cancer Center:
Brain Tumor
Glioma
Tumor resection
Navigated Transcranial Magnetic Stimulation
nTMS
Brain mapping
Motor function
Speech function
Speech mapping

Additional relevant MeSH terms:
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Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases