Clinical trial initiated to determine feasibility, safety of focused ultrasound to treat depression

The first patient with depression has been treated with focused ultrasound. This procedure marks the beginning of a pilot clinical trial to determine the feasibility and safety of MR-guided focused ultrasound to non-invasively destroy a small volume of tissue deep in the brain - the anterior limb of the internal capsule - a well-established target for treating severe depression. In this initial patient, the target was successfully ablated without complications.

This study is being led by neurosurgeon Jin Woo Chang, MD, at Yonsei University College of Medicine in Seoul, Korea.

"There is a need for non-invasive treatment options for patients with depression that cannot be managed through medication," says Dr. Chang, who is president of the Korean Neurosurgical Society. "We were able to conduct the focused ultrasound procedure without complications or serious adverse effects. We will continue to monitor the patient to assess how her depression symptoms change over time."

In this trial, 10 patients with severe depression that is resistant to medication or electroconvulsive therapy will be treated with focused ultrasound using Insightec's Exablate Neuro System. Outcomes will be measured with clinical examinations and MR imaging, as well psychological assessments during a six-month follow-up period.

"Modern clinical series from experienced centers have shown that ablative surgery can be very helpful in many patients with treatment refractory depression and obsessive-compulsive disorder. The ability to place small, well-controlled lesions using focused ultrasound without exposing the patient to the risks of open surgery and direct brain penetration is certainly an attractive new surgical option," says Dr. Rees Cosgrove, head of epilepsy and functional neurosurgery at Brigham and Women's Hospital.

If the results of this pilot study demonstrate that focused ultrasound is feasible and safe, it will lead to a pivotal trial in a larger number of patients to determine long-term safety and efficacy of focused ultrasound to alleviate severe depression.

This trial is supported by the Focused Ultrasound Foundation. "We are encouraged to see the research building on the utility of focused ultrasound as a non-invasive method to treat a range of both neurological and psychiatric disorders. This technology may offer new hope to patients suffering from depression, OCD, Parkinson's, essential tremor, brain tumors and more," says Foundation Chairman Neal Kassell, MD.