Do You Have Dyskinesia Symptoms Or Motor Fluctuations Associated With

PARKINSON’S DISEASE HOW LONG WILL I BE IN THE STUDY? Parkinson's disease (PD) is a chronic, After the ExAblate Neuro procedure, six degenerative, neurologic disorder follow-up visits will be completed during a caused by the death of nerve cells in the one year period. You will have scheduled brain. As the disease progresses, many visits at 1 day, 1 week, 1 month, 3 months, 6 patients develop symptoms such as months, and 1 year after treatment to dyskinesia and motor fluctuations that monitor the success of the procedure. are difficult to manage effectively. HOW CAN I FIND OUT MORE? Dyskinesia is involuntary movements that can become disabling and are a If you have questions or are interested in common complication of PD treatment participating, please contact: with drugs such as levodopa. Do you have Michael Kaplitt, MD PhD CURRENT TREATMENT OPTIONS FOR (212) 746-4966 PARKINSON’S DISEASE Dyskinesia

 Medications – you could continue to Weill Cornell Medicine Department of Symptoms or receive medications. Neurological Surgery (866) 426-7787 Motor  Surgery –a surgical procedure, called

a pallidotomy, can be performed on Additional information is available at: Fluctuations one side of the brain by other www.clinicaltrials.gov methods than with the ExAblate NCT03319485 associated Neuro. This procedure involves destroying brain tissue in a part of ABOUT EXABLATE with the brain called the globus pallidum Exablate Neuro is an innovative medical advanced and has been shown to reduce PD device that uses focused ultrasound together symptoms. with MR imaging to precisely target and treat Parkinson’s  Deep Brain Stimulation (DBS) – a small area deep within the brain through when patients no longer benefit an intact skull. Disease? from medication, DBS may be considered. DBS of the globus pallidum or the subthalamic nucleus If you have advanced Parkinson’s disease and can be performed bilaterally (on are experiencing dyskinesia symptoms or both sides of the brain). The motor fluctuations that are not responding to medicines, you may be eligible for a clinical trial procedure involves implanting an electrical device in your chest with 1 examining a new minimally invasive method to or 2 electrodes in your brain. treat your symptoms.

HOW LONG DOES THE PROCEDURE TAKE? Introduction The entire ExAblate Neuro MRgFUS procedure may take up to four hours. WHO CAN PARTICIPATE?

Patients who: WHAT IS EXABLATE NEURO WHAT ARE THE BENEFITS OF EXABLATE  Men and women, age 30 years and older MR guided FOCUSED NEURO MRgFUS SYSTEM? ULTRASOUND?  Have motor complications of PD on  It is minimally invasive, so no incisions optimum medical treatment ExAblate MRgFUS, a minimally invasive are needed  Are able to undergo MR imaging treatment, uses focused ultrasound waves  There is no radiation  Are responsive to the drug levodopa to destroy tissue within the targeted area  The MRI guidance provides anatomical  in the brain using a transcranial (through Have not had previous PD surgery or placement and temperature monitoring DBS the skull) approach. in real-time as the treatment is being

delivered. Other criteria will be explained by your During the treatment you lie in an MRI doctor. scanner (a special system that provides The full benefits of this treatment will be WHAT WILL HAPPEN IF I TAKE PART IN very detailed images of the brain and evaluated through this study. THIS STUDY? surrounding anatomy). The MRI helps the WHAT ARE SOME OF THE RISKS OF THE You will undergo clinical evaluation of your physician "see" inside the body to PROCEDURE? pinpoint, guide, and continuously monitor PD symptoms and an MRI scan to the treatment. ExAblate Neuro could cause temporary determine if you qualify for the study. If pain, headache, nausea/vomiting, and you are eligible and agree to be in this The focused ultrasound energy is directed slurred or slow speech as a result of study, you will be treated with ExAblate at a small group of cells called the globus swelling in the treated area. There is the and followed up for 12 months for pallidum in the brain. Ultrasound beams possibility of damage to other tissue, but treatment outcome, including safety and are focused through the skull and into the this is minimized through MR imaging which effectiveness. You will need to complete brain similar to a magnifying glass focusing shows the exact location of the focused questionnaires multiple times during the sunlight on paper. Only the spot where the ultrasound. There may be other risks that study. beam is focused gets hot enough to be your doctor will discuss with you. destroyed during the sonication lasting WHAT IS THE COST? about 20 seconds, creating a spot about WHAT IS THE PURPOSE OF THIS STUDY? There is no cost to you for the the size of a coffee bean. The delivery of The goal of this investigational study is to investigational treatment procedure. energy is called a ‘sonication’ and should evaluate the safety and effectiveness of MR not affect other parts of the body. guided Focused Ultrasound (MRgFUS) using Multiple sonications may be delivered the ExAblate Neuro system to perform a until the targeted area is treated. pallidotomy on one side of the brain to treat motor symptoms of Parkinson’s disease (PD).