Navigated Transcranial Magnetic Stimulation in Tumor Surgery

NCT01018290 | Terminated

• 1 other identifier: 2008-P-002325/2
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Distance between motor representation area localization by NBS to that determined by DCS

  immediate post-operative period

• Comparison of DTI results based on using NBS motor representations as seed to those obtained using DCS results as seeds

  immediate post-operative period

Secondary Outcomes (2)

• Comparison of the relative distance of NBS anf fMRI identified motor representations to those determined by DCS

  immediate post-operative period

• Assess safety of navigated TMS in this patient population by capturing all Serious Adverse Events

  During and after navigated TMS examination

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Nexstim Ltd: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Alexandra Golby, MD

  Brigham and Women's Hospital Harvard Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 20, 2009
• First Posted: November 23, 2009
• Study Start: November 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: June 8, 2011

Record last verified: 2011-06

Locations

US (1)