Navigated Transcranial Magnetic Stimulation in Tumor Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01018290
Recruitment Status : Terminated (Recruitment goals not met)
First Posted : November 23, 2009
Last Update Posted : June 8, 2011
Information provided by:
Nexstim Ltd

Brief Summary:

Maximizing surgical removal of brain tumors while minimizing neurologic deficits is challenging. Functional brain tissue may reside close to or even within the abnormality, and inadvertent removal or disturbance of such areas can result in neurologic deficits. At present, the gold standard for identifying critical motor areas in tumor surgery is intraoperative invasive direct current stimulation (DCS) through a handpiece. More recently, new non-invasive preoperative method for brain mapping, functional magnetic resonance imaging (fMRI), may be used to identify the eloquent motor areas. fMRI signals used in localization of the motor areas are generated when the brain is activated during the performance of specific motor tasks. However, as fMRI signals are also generated by sensory input, the resulting fMRI map may include sensory as well as motor areas.

Nexstim has developed a Navigated Brain Stimulation (NBS) system that uses TMS with a software based Navigational System that together may have more specific spatial accuracy.

This study aims to determine whether navigated TMS is able to identify the eloquent motor cortical areas in patients with brain tumors and to determine the clinical accuracy of the procedure by comparing it to results obtained by intraoperative DCS and fMRI.

Condition or disease
Brain Tumors

Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Preoperative Non-Invasive Motor Mapping in Tumor Surgery by Navigated Transcranial Magnetic Stimulation
Study Start Date : November 2009
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors

Navigated TMS examination
20 patients with brain tumor in the vicinity of the central motor region scheduled for elective surgery will undergo pre-operative Navigated TMS examination to determine the localization of primary motor cortex and motor representation areas of specific muscles

Primary Outcome Measures :
  1. Distance between motor representation area localization by NBS to that determined by DCS [ Time Frame: immediate post-operative period ]
  2. Comparison of DTI results based on using NBS motor representations as seed to those obtained using DCS results as seeds [ Time Frame: immediate post-operative period ]

Secondary Outcome Measures :
  1. Comparison of the relative distance of NBS anf fMRI identified motor representations to those determined by DCS [ Time Frame: immediate post-operative period ]
  2. Assess safety of navigated TMS in this patient population by capturing all Serious Adverse Events [ Time Frame: During and after navigated TMS examination ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
20 patients with brain tumor in the vicinity of the central motor region scheduled for elective surgery.Patients aged 18 and over with no other brain abnormalities.

Inclusion Criteria:

  • Male or female subjects 18 years of age and over.
  • A brain tumor in the vicinity of the central region.
  • Mild (BMRC grade 4/5) or no paresis.
  • Obscured anatomy of the central region due to the mass effect/infiltrating growth pattern of the lesion
  • Scheduled for elective surgery under general or local anesthesia.
  • No other known brain abnormalities by history or by structural MRI.
  • Mentally and physically able to undergo MR imaging (fMRI, DTI) and navigated TMS studies
  • Signed informed consent form.

Exclusion Criteria:

  • Implanted metallic parts of implanted electronic devices, including pacemakers, defibrillators, or implant medication pump.
  • Pregnant or trying to become pregnant.
  • History of alcohol abuse, illicit drug use or drug abuse or significant mental illness
  • Hypertensive or hypotensive condition.
  • Any condition that would prevent the subject from giving voluntary informed consent.
  • An implanted brain stimulator.
  • Aneurysm clip or other metal in the head (except mouth
  • Enrolled or plans to enroll in an interventional trial during this study.
  • Scalp wounds or infections.
  • Claustrophobia precluding MRI
  • Frequent seizures (>1/week)

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 identifier (NCT number): NCT01018290

United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Nexstim Ltd
Principal Investigator: Alexandra Golby, MD Brigham and Women's Hospital Harvard Medical School

Responsible Party: Alexandra Golby, MD, Neurosurgery, Brigham and Women's Hospital, Partners Healthcare System, Harvard Medical School Identifier: NCT01018290     History of Changes
Other Study ID Numbers: 2008-P-002325/2
First Posted: November 23, 2009    Key Record Dates
Last Update Posted: June 8, 2011
Last Verified: June 2011