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Clinical Trial Approved Using Focused Ultrasound to Treat Parkinson’s Disease Symptoms
March 14, 2018
Dr. Michael Kaplitt, Vice Chair for Research and the Director of Movement Disorders and Pain at the Weill Cornell Medicine Brain and Spine Center, has been given approval by the Weill Cornell Medicine Institutional Review Board (IRB) to start a clinical trial testing of the use of focused ultrasound to treat movement problems and medication complications in patients with Parkinson's disease.
Dr. Kaplitt will evaluate the safety and efficacy of using focused ultrasound to perform a pallidotomy — a procedure that destroys a tiny portion of the region of the brain that functions abnormally in Parkinson's disease. The device used in this clinical trial has already been approved by the FDA to treat essential tremor (ET).
Dr. Kaplitt was the first doctor in New York to use this device on patients and has successfully treated dozens of patients since then for ET.
The new clinical trial, sponsored by the device's manufacturer, Insightec, will evaluate an estimated 116 participants. After participants undergo the pallidotomy, investigators will evaluate its effectiveness at managing their dyskinesia (involuntary movements).
While there is no cure for Parkinson's disease, there are medications currently available to help patients significantly improve their quality of life, particularly in the early stages of the disease. For patients who no longer derive sufficient benefit from medication, however, or for those who have complications that limit their ability to take medication, Dr. Kaplitt can perform deep brain stimulation surgery (DBS).
In DBS, a neurosurgeon implants an electrode in the brain to improve the function of circuits controlling movement. A battery-operated neurotransmitter is then placed under the collarbone with a wire running under the skin to connect the neurotransmitter to the electrode.
DBS can be very effective, but some patients are reluctant to undergo the implant or may have limitations that prevent them from undergoing implantation surgery. A successful trial for focused ultrasound would alleviate the need to implant a neurotransmitter or perform invasive surgery.
Dr. Kaplitt is a pioneer in studying and treating movement disorders. Last year he was invited to speak at the Nobel Forum at the Karolinska Institute for the 200th anniversary of the publication of James Parkinson's Essay on the Shaking Palsy, which first defined the condition later named for him.
As the principal investigator for the new trial at Weill Cornell Medicine, Dr. Kaplitt will be working with other investigators and participants at select centers throughout the world.
Parkinson's disease is a brain disorder that causes tremor, muscle stiffness, slowness, and other problems of movement. Though it is often associated with tremor or shaking, other symptoms such as muscle stiffness and difficulty starting movements, also called freezing, can have great effects on quality of life.
Complications from medication, including abnormal movements, impulsiveness or addictive behaviors, nightmares and anxiety can also be serious problems. For many patients, everyday tasks such as buttoning a shirt, eating or drinking, writing and typing, speaking clearly, or walking normally can become quite difficult.
Although this new procedure is not intended to cure Parkinson's disease, success with this study could offer patients an unprecedented non-invasive option to greatly enhance the quality of life for those afflicted with the disease.