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

Not Applicable

Withdrawn

• Conditions: Brain Tumor
• Interventions: Procedure: Motor Mapping; Procedure: Speech Mapping

• Registration Number: NCT02165995
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2014-06-11
• Study First Submitted QC: 2014-06-12
• Study First Posted: 2014-06-18
• Study Start: 2014-09
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-28
• Last Update Posted: 2016-12-29
• Primary Completion: 2018-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Navigated Transcranial Magnetic Stimulation (nTMS)	Motor Mapping	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.
Navigated Transcranial Magnetic Stimulation (nTMS)	Speech Mapping	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.

Primary Outcome Measures

Name	Time	Method
Pre and Post-Operative Functional Outcomes Using Navigated Transcranial Magnetic Stimulation (nTMS)	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.