Long-Term Clinical Results: Focused Ultrasound Safe and Effective for Obsessive-Compulsive Disorder (OCD), Depression

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Key Points

  • A clinical trial tested the safety and efficacy of using focused ultrasound to perform a capsulotomy in participants with obsessive-compulsive disorder (OCD) and major depressive disorder (MDD).
  • Long-term results now show that MRgFUS capsulotomy is safe in patients with OCD and MDD and particularly effective for OCD.

A research team at Sunnybrook Health Sciences Centre in Toronto led by Nir Lipsman, MD, PhD, recently published long-term positive results from early phase clinical trials testing the safety and efficacy of using MR-guided focused ultrasound (MRgFUS) to perform a capsulotomy in 27 participants with obsessive-compulsive disorder (OCD, NCT03156335) and major depressive disorder (MDD, NCT03421574). These single center, open-label studies were conducted between June 2017 and January 2023.

After performing baseline imaging scans, the research team administered neuropsychological tests to the 15 participants with OCD [the Yale-Brown Obsessive-Compulsive Scale (YBOCS)] and 12 participants with MDD [the Hamilton Depression 17-point Rating Scale (HAMD-17)]. The treatment team then used Insightec’s Exablate Neuro MRgFUS system to perform ablative lesioning in the anterior limb of the internal capsule. The baseline imaging and testing scales were repeated at 12 months and then again between 18 to 24 months. The threshold for a positive clinical response was defined as 35% or more improvement in the YBOCS for OCD and greater than or equal to 50% reduction in HAMD-17 scores for depression (as compared with baseline).

For OCD, researchers found that baseline YBOCS scores were significantly reduced: 23% after 6 months (p=0.01) and 35% after 12 months (p<0.0001). For MDD, the reduction in HAMD-17 scores were not statistically significant, at 26% and 25%, respectively. Researchers did find a correlation between the anatomic placement of the lesions and positive treatment response in both cohorts. Additionally, there were no serious adverse effects. Notably, at 1- and 2-years after the procedure, the rates of treatment response for OCD were 42% and 67%, respectively, indicating a gradual and sustained response to treatment over time.

“Now, with more than 12 months of follow-up, the capsulotomy results continue to be encouraging,” said Dr. Lipsman. “We found that in patients who are highly treatment refractory, focused ultrasound capsulotomy can lead to marked improvements in anxiety over time. Our current work is focused on optimizing the procedure, enhancing targeting, and determining what distinguishes responders from non-responders”

The group concluded that MRgFUS capsulotomy is safe in patients with OCD and MDD and particularly effective for OCD one year after treatment. Focused ultrasound has been in clinical trials for OCD since 2013.

The study was funded by the Midas Touch Foundation, the Harquail Centre for Neuromodulation, and the Focused Ultrasound Foundation.

See “Long-Term Safety and Efficacy of Focused Ultrasound Capsulotomy for Obsessive-Compulsive Disorder and Major Depressive Disorder” in Biological Psychiatry

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Historical Context

Jin-Woo Chang, MD, PhD, pioneered modern focused ultrasound psychiatric treatments in Korea. In 2013, he began a clinical trial for OCD, and the results were published in 2014. In 2015, Dr. Chang began a clinical trial for depression, and those results were published in 2020.