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

November 20, 2009
June 7, 2011
November 2009
September 2010   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01018290 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Navigated Transcranial Magnetic Stimulation in Tumor Surgery
Preoperative Non-Invasive Motor Mapping in Tumor Surgery by Navigated Transcranial Magnetic Stimulation

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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
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Non-Probability Sample

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.

Brain Tumors
Not Provided
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
20
September 2010
September 2010   (final data collection date for primary outcome measure)

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)
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01018290
2008-P-002325/2
No
Alexandra Golby, MD, Neurosurgery, Brigham and Women's Hospital, Partners Healthcare System, Harvard Medical School
Nexstim Ltd
Not Provided
Principal Investigator: Alexandra Golby, MD Brigham and Women's Hospital Harvard Medical School
Nexstim Ltd
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP