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


N/A
18 Years
80 Years
Not Enrolling
Both
Brain Tumors

Thank you

Trial Information

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


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)

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Distance between motor representation area localization by NBS to that determined by DCS

Outcome Time Frame:

immediate post-operative period

Safety Issue:

No

Principal Investigator

Alexandra Golby, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Brigham and Women's Hospital Harvard Medical School

Authority:

United States: Institutional Review Board

Study ID:

2008-P-002325/2

NCT ID:

NCT01018290

Start Date:

November 2009

Completion Date:

September 2010

Related Keywords:

  • Brain Tumors
  • Brain Neoplasms

Name

Location

Brigham and Women's HospitalBoston, Massachusetts  02115