Navigated Transcranial Magnetic Stimulation in Tumor Surgery
|ClinicalTrials.gov Identifier: NCT01018290|
Recruitment Status : Terminated (Recruitment goals not met)
First Posted : November 23, 2009
Last Update Posted : June 8, 2011
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 or disease|
|Study Type :||Observational|
|Estimated Enrollment :||20 participants|
|Official Title:||Preoperative Non-Invasive Motor Mapping in Tumor Surgery by Navigated Transcranial Magnetic Stimulation|
|Study Start Date :||November 2009|
|Actual Primary Completion Date :||September 2010|
|Actual Study Completion Date :||September 2010|
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
- Distance between motor representation area localization by NBS to that determined by DCS [ Time Frame: immediate post-operative period ]
- 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 ]
- Comparison of the relative distance of NBS anf fMRI identified motor representations to those determined by DCS [ Time Frame: immediate post-operative period ]
- Assess safety of navigated TMS in this patient population by capturing all Serious Adverse Events [ Time Frame: During and after navigated TMS examination ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01018290
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Alexandra Golby, MD||Brigham and Women's Hospital Harvard Medical School|