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Sponsors and Collaborators: |
University of California, San Francisco Surgi-Vision Inc |
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Information provided by: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT00792532 |
The purpose of this study is to determine the safety and effectiveness of a new procedure for placing DBS electrodes, in which the entire surgery is performed within an MRI scanner ("interventional MRI"), with the patient fully asleep (under general anesthesia). 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. In this study, 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.
Condition | Intervention | Phase |
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Parkinson's Disease Dystonia |
Procedure: interventional MRI for implantation of DBS electrodes Device: DBS electrodes |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Use of Interventional MRI for Implantation of Deep Brain Stimulator Electrodes |
Estimated Enrollment: | 100 |
Study Start Date: | July 2003 |
Estimated Study Completion Date: | July 2013 |
Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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iMRI: Experimental |
Procedure: interventional MRI for implantation of DBS electrodes
DBS implantation will be performed entirely within a Phillips 1.5T MRI scanner at UCSF and the Siemens Avanto 1.5T MRI scanner at the SFVAMC.
Device: DBS electrodes
Deep brain stimulation (DBS) electrodes
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Deep brain stimulation (DBS) is a new but increasingly common surgical technique for the treatment of Parkinson's disease. The current technical approach to DBS implantation involves frame-based stereotaxy. In this method, a stereotactic frame is rigidly fixed to the patient's skull, an MRI is obtained, an anatomic target is identified, and the coordinates of the target in stereotactic space are calculated. Instruments are mounted on the stereotactic frame that point to the calculated coordinate. However, due to the inherent inaccuracies in standard frame-based stereotaxy, a complex 6-hour procedure then ensues to "map" the brain target with microelectrodes, place the lead, and return to the MR unit to confirm proper placement.
The goal of this project is to test the feasibility of performing DBS implantation entirely within the Phillips 1.5T open magnet MRI machine. Prior to study initiation, instrumentation and MR protocols were tested using a phantom head. In the proposed project, subthalamic nucleus or gGlobus pPallidus DBS implantations will be performed bilaterally in patients with Parkinson's disease or dystonia. Patients will be under general anesthesia. Targeting and lead verification are performed with imaging alone, without physiologic mapping. Data is to be gathered on the following: Operative time, degree of benefit with bilateral implantation (changes in standard rating scales of motor disability), DBS voltage requirements, complications), and electrode location by MR. These measures will be compared with our historical controls, previously entered into our research database, in which electrodes were placed by the standard methods. We expect that the use of near real time MR will improve the speed and accuracy of DBS implantation, and eliminate the need for invasive physiological monitoring.
Ages Eligible for Study: | 7 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Parkinson's Disease
Inclusion Criteria:
Exclusion Criteria:
Dystonia Inclusion Criteria
Exclusion Criteria
United States, California | |
University of California, San Francisco | Recruiting |
San Francisco, California, United States, 94143 | |
Contact: Jamie Grace, B.S. 415-353-8328 jamie.grace@ucsf.edu | |
Contact: Monica Volz, M.S.N. 415-502-3576 monica.volz@ucsf.edu | |
San Francisco Veterans Administration Medical Center | Recruiting |
San Francisco, California, United States, 94121 | |
Contact: Susan Heath, M.S.N. 415-221-4810 ext 2505 Susan.Heath@va.gov | |
Contact: Paul Larson, M.D. 415-221-4810 ext 4791 larsonp@neurosurg.ucsf.edu |
Principal Investigator: | Philip Starr, M.D. | University of California, San Francisco; SFVAMC |
Principal Investigator: | Paul Larson, M.D. | University of California, San Francisco; SFVAMC |
Principal Investigator: | Jill L Ostrem, MD | University of California San Francisco, SFVAMC |
Principal Investigator: | Alastair J Martin, PhD | University of California, San Francisco |
Responsible Party: | University of California, San Francisco ( Philip Starr, M.D., Ph.D ) |
Study ID Numbers: | iMRI |
Study First Received: | November 14, 2008 |
Last Updated: | November 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00792532 |
Health Authority: | United States: Institutional Review Board |
Dystonic Disorders Ganglion Cysts Basal Ganglia Diseases Dystonia Central Nervous System Diseases Brain Diseases Neurodegenerative Diseases |
Dyskinesias Signs and Symptoms Parkinson Disease Movement Disorders Neurologic Manifestations Parkinsonian Disorders |
Nervous System Diseases |