In a North American first, researchers at Sunnybrook Health Sciences Centre in Toronto have launched a pilot clinical trial to determine the safety, feasibility, and preliminary efficacy of using focused ultrasound to help patients with treatment-resistant major depression.
The trial will use focused ultrasound to disrupt a key circuit in the brain long associated with major depression, by destroying a 5mm structure known as the anterior limb of the internal capsule.
“Clinicians have used neurosurgical techniques such as radiofrequency ablation, radiosurgery, and deep brain stimulation of this target in the brain and have had success in alleviating symptoms of depression,” said Neal F. Kassell, MD, chairman of the Focused Ultrasound Foundation. “Focused ultrasound is an alternative method that could produce the same results noninvasively and without the harmful effects or complications of radiation or surgery, while decreasing the cost of care.”
“Although we are in the early stages of investigating the safety and efficacy of focused ultrasound for patients with depression, it has the potential to be another treatment option, and expand the number of patients who can be treated,” says Dr. Nir Lipsman, principal investigator of the trial, and Director of the Harquail Centre for Neuromodulation at Sunnybrook.
Six patients will be treated in the trial using Insightec’s Exablate Neuro device. Patients will be assessed for severity of depression and level of functioning at one, three, six, and 12 months post-treatment.
This trial follows a similar experience completed at the YUMC Severance Hospital in Seoul, Korea, published in Biological Psychiatry.
The trial at Sunnybrook will be funded in part by the Foundation and builds upon the Canadian site’s impressive portfolio of research in focused ultrasound for brain disorders. In November 2016, Sunnybrook was designated as one of the Foundation’s Centers of Excellence.
Read Sunnybrook’s press release >
FAQ about Depression and Focused Ultrasound
Video of the First Patient
Major depression is a psychiatric disorder in which a person consistently experiences feelings of sadness, guilt and worthlessness for at least two weeks. Depression can interfere with daily life, often leading to a loss of interest in activities, trouble sleeping and impaired concentration. According to the World Health Organization, depression represents one of the largest and most important sources of human morbidity and is a major source of lost productivity and health care costs.
About Focused Ultrasound
Multiple intersecting beams of ultrasound are directed and concentrated on a target; much like a magnifying glass can focus beams of light on a single point to burn a hole in a leaf. Where each individual beam passes through the tissue, there is no effect. But, at the focal point, the beams of ultrasound energy can produce many important biological effects. Today, focused ultrasound is approved in the United States to treat essential tremor, uterine fibroids, and the prostate, as well as reduce pain from bone metastases. The technology is also being studied for more than 90 other diseases, including Parkinson’s, Alzheimer’s, hypertension, and tumors of the brain, liver, breast, and pancreas. Focused ultrasound has certain attributes that create the potential for a unique role in cancer immunotherapy when compared to the other modalities, and several preclinical and clinical studies have demonstrated that FUS can elicit an immune response. Read more >
About the Focused Ultrasound Foundation
The Focused Ultrasound Foundation was created to improve the lives of millions of people worldwide by accelerating the development of focused ultrasound, an early-stage noninvasive therapeutic technology with the potential to transform the treatment of many medical disorders. The Foundation is dedicated to ensuring that focused ultrasound finds its place as a mainstream therapy within years, not decades, and works to fund research, foster collaboration, and build awareness among patients and professionals. Since its establishment in 2006, it has become the largest non-governmental source of funding for focused ultrasound research.