Researchers at Sunnybrook Health Sciences Centre in Toronto have begun a new clinical trial to evaluate the feasibility and safety of focused ultrasound to alleviate symptoms in patients with refractory obsessive-compulsive disorder (OCD). To date, three of six patients have been treated.
The pilot study will enroll a total of six patients, ages 25 to 80, to undergo a noninvasive procedure to create bilateral lesions in the brain using InSightec’s Exablate Neuro MR-guided focused ultrasound device. Ultrasound energy is used to generate a precise lesion in the anterior limb of the internal capsule, a region in the brain that plays a major role in the neural circuits typically dysfunctional in patients with OCD.
“Our trial follows the pioneering work of Dr. Jin Woo Chang at Yonsei University College of Medicine in Korea,” says Nir Lipsman, MD, (pictured) principal investigator of the Sunnybrook study. “Results from this study will help us confirm and extend his results in a different group of patients to determine if this treatment option is safe and effective for those who do not respond to other treatments.” The procedure was approved in South Korea by the Ministry of Food and Drug Safety following the publication of the pilot study there.
FUSF founder and chairman Neal F. Kassell, MD, adds, “The Foundation’s Psychiatric Disorders Task Force is a highly collaborative group that has worked to design and implement this study protocol.” The task force, which includes neurosurgeons, psychiatrists, and imaging experts from five institutions, is led by Suzanne LeBlang, MD, and Timothy Meakem, MD, the Foundation’s chief medical officers. “We are excited about this study beginning at Sunnybrook in Toronto. We will also be enrolling patients in a similar study in the US at Brigham and Women’s in Boston and at Stanford Medicine,” said Kassell.
Funded by the Focused Ultrasound Foundation, the Sunnybrook study lays the groundwork for using focused ultrasound for a variety of psychiatric disorders. “OCD is the first clinical application, and the next psychiatric disorder we are interested in is depression,” says Dr. Lipsman. “For some patients and clinicians, focused ultrasound is preferable over other more traditional forms of neurosurgery. We are hopeful that our trial will provide the safety and efficacy data needed to develop larger trials in more patients, and to determine what role focused ultrasound can play in extremely challenging mental illnesses like OCD and depression.”
In addition to beginning this multisite study, Dr. Lipsman and his colleagues are hosting the first Psychiatric Disease Workshop in October 2017, supported by the Focused Ultrasound Foundation, to create a roadmap for additional preclinical and clinical studies with OCD and other psychiatric diseases.
For more information on the clinical trial in Toronto, which is currently open only to Canadian residents, call 416-480-6100, ext. 1650. Sunnybrook Health Sciences Centre is a Foundation Center of Excellence, the only Canadian site with this designation.
OCD is a mental illness characterized by recurring anxiety-provoking thoughts (obsessions) that are alleviated by ritualistic actions or purposeful contemplation (compulsions) of the intruding emotion or idea. OCD is driven by pathological brain circuits, and has been linked to imbalances in the neurotransmitters serotonin and dopamine, which are known to play a role in regulating anxiety. OCD is a chronic disorder with a waxing and waning course. The incidence in the general population is 2–3 percent, with most people being diagnosed by age 19. Symptoms are wide ranging and varied, and two-thirds of patients with OCD also develop major depression during their lifetime.