Use of Interventional MRI for Implantation of Deep Brain Stimulator Electrodes

Summary

The purpose of this study is to gather observational data on an already FDA-approved implantation technique for deep brain stimulation (DBS) in which the entire surgery is performed within an MRI scanner ("interventional MRI", or iMRI). With this surgical technique, the patient is fully asleep (under general anesthesia) during DBS implantation. The standard method for the placement of deep brain stimulators does not use MRI during the actual DBS placement. The standard method involves placement of a rigid frame on the patient's head, performance of a short MRI scan, transport to the operating room, placement of the DBS electrodes in the operating room, and return to the MRI suite for another MR to confirm correct electrode placement. In the standard method, the patient must be awake for 2-4 hours in the operating room to have "brain mapping" performed, where the brain target is confirmed by passing "microelectrodes" (thin wires) into the brain to record its electrical activity. In the standard method, general anesthesia is not required. With the iMRI technique, the surgery is guided entirely by MRI images performed multiple times as the DBS electrode is advanced. This eliminates the need for the patient to be awake, and eliminates the need for passing microelectrodes into the brain before placing the permanent DBS electrode.

Conditions

• Parkinson's Disease
• Dystonia

Interventions

PROCEDURE

interventional MRI for implantation of DBS electrodes

DBS implantation will be performed entirely within a Phillips 3T MRI scanner

DEVICE

DBS electrodes

Deep brain stimulation (DBS) electrodes

Sponsors & Collaborators

• MRI Interventions, Inc.

  collaborator INDUSTRY

• University of California, San Francisco

  lead OTHER

Principal Investigators

• Philip Starr, M.D., Ph.D. · University of California, San Francisco; SFVAMC

• Paul Larson, M.D. · University of California, San Francisco; SFVAMC

• Jill L Ostrem, MD · University of California San Francisco, SFVAMC

• Alastair J Martin, PhD · University of California, San Francisco

Eligibility

Min Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2003-07-31

Primary Completion

2019-03-31

Completion

2019-03-31

FDA Device

Yes

Countries

• United States

Study Locations