Navigated Transcranial Magnetic Stimulation in Tumor Surgery

NCT ID: NCT01018290

Last Updated: 2011-06-08

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2010-09-30

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.

Conditions

Brain Tumors

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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

No interventions assigned to this group

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nexstim Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Neurosurgery, Brigham and Women's Hospital, Partners Healthcare System, Harvard Medical School

Principal Investigators

Alexandra Golby, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital Harvard Medical School

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2008-P-002325/2

Identifier Type: -

Identifier Source: org_study_id