Navigated Transcranial Magnetic Stimulation in Tumor Surgery

This study has been terminated.
(Recruitment goals not met)
Sponsor:
Information provided by:
Nexstim Ltd
ClinicalTrials.gov Identifier:
NCT01018290
First received: November 20, 2009
Last updated: June 7, 2011
Last verified: June 2011
  Purpose

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
Brain Tumors

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Preoperative Non-Invasive Motor Mapping in Tumor Surgery by Navigated Transcranial Magnetic Stimulation

Resource links provided by NLM:


Further study details as provided by Nexstim Ltd:

Primary Outcome Measures:
  • Distance between motor representation area localization by NBS to that determined by DCS [ Time Frame: immediate post-operative period ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparison of the relative distance of NBS anf fMRI identified motor representations to those determined by DCS [ Time Frame: immediate post-operative period ] [ Designated as safety issue: No ]
  • Assess safety of navigated TMS in this patient population by capturing all Serious Adverse Events [ Time Frame: During and after navigated TMS examination ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: November 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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.

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01018290

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

No publications provided

Responsible Party: Alexandra Golby, MD, Neurosurgery, Brigham and Women's Hospital, Partners Healthcare System, Harvard Medical School
ClinicalTrials.gov Identifier: NCT01018290     History of Changes
Other Study ID Numbers: 2008-P-002325/2
Study First Received: November 20, 2009
Last Updated: June 7, 2011
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 16, 2014