Navigated Transcranial Magnetic Stimulation in Tumor Surgery

Brain Tumors Clinical Trial

Official title:

Preoperative Non-Invasive Motor Mapping in Tumor Surgery by Navigated Transcranial Magnetic Stimulation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01018290
• Other study ID #: 2008-P-002325/2
• Status: Terminated
• Phase: N/A
• First received: November 20, 2009
• Last updated: June 7, 2011
• Start date: November 2009
• Est. completion date: September 2010

Study information

• Verified date: June 2011
• Source: Nexstim Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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)

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Brain Tumors

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Nexstim Ltd

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distance between motor representation area localization by NBS to that determined by DCS		immediate post-operative period	No
Primary	Comparison of DTI results based on using NBS motor representations as seed to those obtained using DCS results as seeds		immediate post-operative period	No
Secondary	Comparison of the relative distance of NBS anf fMRI identified motor representations to those determined by DCS		immediate post-operative period	No
Secondary	Assess safety of navigated TMS in this patient population by capturing all Serious Adverse Events		During and after navigated TMS examination	Yes