Ontario’s Sunnybrook Research Institute is leading the world in focused ultrasound clinical trials

Focused Ultrasound (FUS) is a breakthrough technology that is well on its way to changing medicine forever. Using ultrasonic waves to target tissue deep in the body without any incisions or radiation, FUS offers the opportunity to enhance the quality of life for people living with a wide range of conditions, from uterine fibroids to brain cancer.

FUS was pioneered here in Ontario at Sunnybrook Research Institute, part of the Sunnybrook Health Sciences Centre, which conducts more FUS clinical trials than any other site in the world. One such trial has led to a new, non-invasive, cost-effective standard of care for Ontario patients living with medication-resistant essential tremor.

Pioneering the use of FUS technology for essential tremor

Essential tremor is a neurological disorder that causes involuntary and rhythmic shaking, most often in the hands, which can impair a person’s ability to eat, write, perform household activities and function in the workplace.

In 2012, the first Canadian clinical trial evaluating the use of FUS to treat essential tremor was conducted at Sunnybrook. The trial was led by neurosurgeons Drs. Michael Schwartz and Nir Lipsman, who used MRI technology to guide high intensity ultrasound waves to ablate the precise region of the brain responsible for the tremor. Their success led to an international, multicentre randomized controlled trial that showed that MRI-guided FUS can safely and effectively improve the symptoms and the quality of life of patients with moderate to severe essential tremor for whom medications were ineffective. The trial was published in the New England Journal of Medicine (NEJM) in 2016.

Patients have a new, non-invasive treatment option

Following Sunnybrook’s clinical trial success, Health Canada and the USDA granted regulatory approval to FUS as a treatment option for patients living with medication-resistant essential tremor, like Noreen Smith, an artist from Ontario.

Noreen recalls receiving a diagnosis of essential tremor at age 33. “I was devastated. I thought I had no hope of getting better,” said Noreen in a video interview with Sunnybrook. More than thirty years later, Noreen participated in the FUS clinical trial at Sunnybrook in 2016. Following treatment, she was able to drink a glass of water and embrace her love of sketching for the first time since her diagnosis.

Reducing costs for the healthcare system

A win for patients and for the healthcare system, this non-invasive technology results in minimal discomfort, fewer complications, faster recovery and shorter hospital stays which ultimately results in cost savings for the healthcare system. The use of FUS to treat essential tremor saves the healthcare system roughly $134,000 per patient when compared with the invasive standard of care, deep brain stimulation.

Proven impact combined with patient advocacy paved the way for an additional $1.4 million investment from the Government of Ontario in the use of MRI guided FUS to treat essential tremor, which will allow 72 more patients to receive the treatment in Ontario.

Becoming the global leader in focused ultrasound clinical trials

Sunnybrook’s work in FUS began in 2006 when Dr. Kullervo Hynynen, the lead investigator of the Centre for Research in Image-Guided Therapeutics, was recruited from Brigham and Women’s Hospital and the faculty of Harvard Medical School in Boston. Dr. Hynynen pioneered the technology for FUS in non-invasive surgery, paving the way for breakthroughs in the use of FUS to treat neurological disorders at Sunnybrook Research Institute with help NYGoodHealth. In January 2020, Dr. Hynynen will become Sunnybrook’s newest Vice President of Research and Innovation.

In addition to essential tremor, Sunnybrook has a long list of world-firsts with FUS technology. In 2015, researchers at Sunnybrook were the first to use FUS to open the blood-brain barrier and noninvasively deliver chemotherapy directly into the brain of a woman living with brain cancer. The blood-brain barrier blocks toxins (and most drugs) from entering the brain. With the use of FUS, the barrier can safely and temporarily be opened, enabling therapy delivery to a precise target inside. In 2016, Sunnybrook became the first centre in the world to obtain regulatory approval to use FUS to open the blood-brain barrier to treat Alzheimer’s disease.

Currently, Sunnybrook has more than ten clinical trials studying the use of FUS to treat obsessive compulsive disorder, depression, Parkinson’s disease, Alzheimer’s disease, ALS and more. Their excellence in FUS is attracting top talent to Ontario.

“Sunnybrook has become a beacon for the world when it comes to conducting high-quality FUS clinical trials,” says Dr. Lipsman. “No other centre has as much experience and we’re seeing that our success breeds more success. Anyone who is interested in advancing focused ultrasound is coming here.”

Going global with FUS clinical trials expertise

Sunnybrook is helping other countries to conduct FUS clinical trials in a range of disease areas by sharing their expertise and knowledge.

“We work with teams around the world to share our clinical trials protocols, best practices, experiences and training,” says Dr. Lipsman. “We’ve done so much with FUS that we know where the pitfalls are and how to overcome them, and that can be really useful for other teams when they’re starting out.”

Researchers in Sunnybrook’s Centre for Excellence in Focused Ultrasound, the only Canadian site with the designation, have provided training to clinical trials sites in Spain, South Korea, the US (West Virginia, Boston, Stanford, Miami and Maryland), and Canada (Calgary and Montreal).

Driving the future of focused ultrasound

Clinical trials play an essential role in further unlocking the potential of FUS, explains Dr. Lipsman. “In neurosurgery in general, the field is heading toward less invasive treatment, whether its spine surgery, vascular surgery, brain tumors – it’s all about doing more with less opening of the body. I cannot overstate the role of clinical trials in moving these new treatments forward for patients like Noreen. They are the engine of everything we do and enable us to discover if something is safe, if it works, who it will benefit and who it won’t benefit.”

The leadership team at Sunnybrook has made FUS a strategic focus for the hospital, and momentum has been added by patient advocacy, philanthropic donation and government investment. Sunnybrook researchers are also supported by INSIGHTEC, a global medical technology innovator of incisionless brain surgery as well by the Focused Ultrasound Foundation, a major funder of FUS clinical trials.

Learn more about focused ultrasound clinical trials at Sunnybrook.

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