NCT02165995

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.

Trial Health

10
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Status
withdrawn

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Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 11, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 18, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Last Updated

December 29, 2016

Status Verified

December 1, 2016

Enrollment Period

4 years

First QC Date

June 11, 2014

Last Update Submit

December 28, 2016

Conditions

Brain Tumor

Keywords

Brain TumorGliomaTumor resectionNavigated Transcranial Magnetic StimulationnTMSBrain mappingMotor functionSpeech functionSpeech mapping

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 months

Study Arms (1)

Navigated Transcranial Magnetic Stimulation (nTMS)

EXPERIMENTAL

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 MappingProcedure: Speech Mapping

Interventions

Motor MappingPROCEDURE

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.

Navigated Transcranial Magnetic Stimulation (nTMS)
Speech MappingPROCEDURE

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.

Navigated Transcranial Magnetic Stimulation (nTMS)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients with a history of uncontrolled seizures
  • Patients with metal implant or a cardiac pacemaker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Brain NeoplasmsGliomaSpeech

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueVerbal BehaviorCommunicationBehavior

Study Officials

  • Sujit Prabhu, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2014

First Posted

June 18, 2014

Study Start

September 1, 2014

Primary Completion

September 1, 2018

Last Updated

December 29, 2016

Record last verified: 2016-12