FUSF Funding Two Clinical Trials at Sunnybrook Health Sciences Centre


Studies are recruiting patients with essential tremor, brain tumors

The Focused Ultrasound Surgery Foundation has announced it is funding two new clinical trials at Sunnybrook Health Sciences Centre in Toronto. The studies will evaluate the feasibility and safety of MR-guided focused ultrasound as a treatment for essential tremor and malignant brain tumors. Performed under protocols approved by Health Canada, the noninvasive treatments will be administered through patients’ intact skulls, and study participants will remain awake – no anesthesia will be administered. The Sunnybrook team will follow each patient’s progress for three months with contrast MRI and clinical examinations.

“Because the brain is the most difficult organ to treat, we believe that one of the best ways to validate and advance MR-guided focused ultrasound is to support the rapid development of promising brain applications,” says Neal Kassell, MD, chairman of the Focused Ultrasound Surgery Foundation. “We are delighted to be collaborating with the team at Sunnybrook, which is one of the world’s pre-eminent focused ultrasound sites.”  Both clinical studies will evaluate the mid-frequency version of the ExAblate Neuro, a transcranial system manufactured by Insightec, Ltd. of Israel. Currently, the ExAblate is the only focused ultrasound system on the market with the capability to perform brain procedures.    

The Foundation supports technical, preclinical and clinical projects to accelerate progress in selected brain indications through its Brain Program. Launched in 2009, the program provides both financial and infrastructure support to the worldwide focused ultrasound community. Its support activities include Steering Committees, a Data and Safety Monitoring Board and a Core Imaging Lab.

Essential tremor study

Sunnybrook joins the University of Virginia in pioneering the use of MR-guided focused ultrasound to treat patients with essential tremor that has not been controlled by medications.

Led by Michael Schwartz, MD, division head of Neurosurgery at Sunnybrook, this study will treat an area deep within the brain – the ventralis intermedius nucleus of the thalamus, which is known to be associated with movement disorders. Six patients between the ages of 18 and 80 are expected to be treated during the study.

In a joint statement, Schwartz and study coordinator Nir Lipsman, MD said, “Our research team is optimistic that this trial will lead to safe and effective treatment options for patients with essential tremor in the future.”

Telephone inquiries regarding Sunnybrook’s essential tremor study can be directed to Karen Ng at 416-790-0809.

Brain tumor study

Sunnybrook’s brain tumor study is enrolling patients who have metastatic brain cancer or recurrent glioma. To be eligible for the study, patients must be between the ages of 18 and 75 and have failed standard therapy with surgery and/or radiation. Led by neurosurgeon Todd Mainprize, MD, the study will treat ten patients, all of whom will be recruited in clinic at Sunnybrook.

Subsequent clinical trials are expected to evaluate MR-guided focused ultrasound’s clinical efficacy in treating brain tumors. 

Written by Ellen C., McKenna