MR Guided Focused Ultrasound Surgery for Tremor Dominant Parkinson’s


16203

A Feasibility Study to Evaluate Safety and Initial Effectiveness of ExAblate Transcranial MR Guided Focused Ultrasound for Unilateral Thalamotomy in the Treatment of Medication-Refractory Tremor Dominant Idiopathic Parkinson’s Disease.

Neurological Surgery

Elias William (Jeff), J

Dr. Jeff Elias at the University of Virginia Health System is investigating a non-invasive technique to make a small heat-induced lesion an area of the brain associated with Parkinson’s tremor. This same targeted area of the brain is sometimes used in other surgical treatments for Parkinson’s symptoms. This investigational technique is novel in that the lesion is made using focused ultrasound waves that converge precisely, creating a heated spot at the target. Because the ultrasound waves can pass through the skull, there is no need to make a skin incision, drill a hole in the skull, penetrate the brain with a probe, or implant any type of hardware. The procedure occurs inside of an MRI machine so that the patient is monitored continuously with real-time brain imaging and temperature mapping. The FDA has given approval for 30 patients to be enrolled in this clinical trial. Eligible participants include patients, age 30 or older, with tremor-dominant Parkinson’s that cannot be managed by medication alone. This is a randomized clinical trial where ten of the 30 patients will be randomly assigned to a sham procedure where no ultrasound power is delivered. After three months study participation, subjects who received a sham procedure will be offered to repeat the procedure at full therapeutic intensity. All study-specific tests (labs, CT, ultrasound, MRIs), procedures and clinic visits will be provided as part of a research grant without cost to the participants. Study participation includes several screening visits, a treatment visit with overnight hospital stay for observation, and four or more follow-up visits over twenty-four months. For patients randomly assigned to a sham procedure, both the sham procedure and a therapeutic procedure will be paid for out of study funds. To sign up to be in the candidate pool for this study and other future Focused Ultrasound Surgery for Movement Disorders studies, please visit https://www.healthsystem.virginia.edu/focusedultrasoundtrial/. This candidate database (IRB#16034) is used for trial announcements as well as pre-screening for relevant trials. For more information about these studies please contact Johanna Loomba, study coordinator, by email at FUSbrain@virginia.edu. You may also contact us by phone at 434-243-1435, but email is encouraged.


Adult

Focused Ultrasound Surgery
Movement Disorders
Parkinson's Disease

Neurosurgery
Neurology
Radiology/Medical Imaging

Ill

No Compensation

Johanna Loomba

jjl4d@virginia.edu

4349245859