Clinical trial NCT01018290: Navigated Transcranial Magnetic Stimulation in Tumor Surgery
Official title: Preoperative Non-Invasive Motor Mapping in Tumor Surgery by Navigated Transcranial Magnetic Stimulation
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Brain Tumors
Lead sponsor: Nexstim Ltd
Sponsor class: INDUSTRY
First posted: 2009-11-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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)

Primary outcomes:
measure: Distance between motor representation area localization by NBS to that determined by DCS
timeFrame: immediate post-operative period
measure: Comparison of DTI results based on using NBS motor representations as seed to those obtained using DCS results as seeds
timeFrame: immediate post-operative period
Secondary outcomes:
measure: Comparison of the relative distance of NBS anf fMRI identified motor representations to those determined by DCS
timeFrame: immediate post-operative period
measure: Assess safety of navigated TMS in this patient population by capturing all Serious Adverse Events
timeFrame: During and after navigated TMS examination
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital Harvard Medical School
name: Alexandra Golby, MD
role: PRINCIPAL_INVESTIGATOR
References: