Focused Ultrasound Therapy

Outside Approval Square Focused ultrasound is an early stage, noninvasive therapeutic technology with the potential to improve the quality of life and decrease the cost of care for patients with depression. This novel technology focuses beams of ultrasonic energy precisely and accurately on targets deep in the brain without damaging surrounding normal tissue. 

How it Works
Where the beams converge, focused ultrasound produces thermal ablation, meaning that the targeted tissue is heated and destroyed where the beams converge.

Advantages
Current treatments for depression include medications, electroconvulsive therapy, surgery (radiofrequency or laser ablation, deep brain stimulation), or stereotactic radiosurgery (gamma knife, linear accelerator), all of which have limitations and side effects.

Clinical Trials SquareFocused ultrasound has the potential to provide an alternative to invasive surgery or radiosurgery via precise thermal ablation, or to augment drug therapy.

Focused ultrasound is noninvasive – no incisions, holes in the skull, electrodes in the brain – and therefore has reduced risk for infection and blood clots. It also enables precise targeting and minimizes damage to non-targeted, healthy brain. Focused ultrasound can also be a complement to drug therapy, enabling enhanced delivery of therapies into the brain via temporary opening of the blood-brain barrier.

Clinical Trials

A clinical trial was completed at the YUMC Severance Hospital in Seoul, Korea evaluated the feasibility, safety and initial efficacy of focused ultrasound in the treatment of major depressive disorder for patients who are not candidates for, or who choose not to undergo, more invasive procedures. This study was published in June 2020. 

A clinical trial evaluating treatment of patients with refractory major depressive disorder has begun in Canada. This trial is only open to citizens of Canada.

See here for a list of treatment sites
See here for a list of clinical trials sites
See here for a list of laboratory research sites

Regulatory Approval and Reimbursement

Focused ultrasound is only approved by for the treatment of depression in Korea. Outside of the South Korean National Health Insurance System, we are not aware of this treatment reimbursed by any other medical insurance providers.

Additional Resources

National Institute of Mental Health
One Mind
Depression and Bipolar Support Alliance

Notable Papers

Davidson B, Mithani K, Huang Y, Jones RM, Goubran M, Meng Y, Snell J, Hynynen K, Hamani C, Lipsman N. Technical and radiographic considerations for magnetic resonance imaging-guided focused ultrasound capsulotomy. J Neurosurg. 2020 Sep 25:1-9. doi: 10.3171/2020.6.JNS201302.

Wang F, Li N, Wei X, Jia X, Liu H, Wang Y, Shi Y, Pan M, Wang Y, Yin Y, Yan F, Chen Y. MRI-Guided Focused Ultrasound-Induced Blood Brain Barrier Disruption to Deliver Glial Cell Line Derived Neurotropic Factor Proteins into Brain to Treat Rat Depression. J Biomed Nanotechnol. 2020 May 1;16(5):626-639. doi: 10.1166/jbn.2020.2914.

Davidson B, Hamani C, Huang Y, Jones RM, Meng Y, Giacobbe P, Lipsman N. Magnetic Resonance-Guided Focused Ultrasound Capsulotomy for Treatment-Resistant Psychiatric Disorders. Oper Neurosurg (Hagerstown). 2020 Jul 31:opaa240. doi: 10.1093/ons/opaa240.

Chang JG, Jung HH, Kim SJ, Chang WS, Jung NY, Kim CH, Chang JW. Bilateral thermal capsulotomy with magnetic resonance-guided focused ultrasound for patients with treatment-resistant depression: A proof-of-concept study. Bipolar Disord. 2020 Jun 24. doi: 10.1111/bdi.12964.

Davidson, B., Hamani, C., Rabin, J.S. et al. Magnetic resonance-guided focused ultrasound capsulotomy for refractory obsessive compulsive disorder and major depressive disorder: clinical and imaging results from two phase I trials. Mol Psychiatry (2020). doi: 10.1038/s41380-020-0737-1.

Mooney SJ, Nobrega JN, Levitt AJ, Hynynen K. Antidepressant effects of focused ultrasound induced blood-brain-barrier opening. Behav Brain Res. 2018;342:57-61. doi:10.1016/j.bbr.2018.01.004.

Volpini M, Giacobbe P, Cosgrove GR, Levitt A, Lozano AM, Lipsman N. The History and Future of Ablative Neurosurgery for Major Depressive Disorder. Stereotact Funct Neurosurg. 2017 Jul 20;95(4):216-228. doi: 10.1159/000478025.

Kim M., Kim C.-H., Jung H.H., Kim S.J. & Chang J.W. Treatment of major depressive disorder via magnetic resonance–guided focused ultrasound surgery. Biological Psychiatry (2017), doi: 10.1016/j.biopsych.2017.05.008.

Tsai SJ. Transcranial focused ultrasound as a possible treatment for major depression. Med Hypotheses. 2015 Apr;84(4):381-3. doi: 10.1016/j.mehy.2015.01.030. Epub 2015 Jan 31.

Jung HH, Kim SJ, Roh D, Chang JG, Chang WS, Kweon EJ, Kim CH, Chang JW. Bilateral thermal capsulotomy with MR-guided focused ultrasound for patients with treatment-refractory obsessive-compulsive disorder: a proof-of-concept study. Mol Psychiatry. 2015 Oct;20(10):1205-11. doi: 10.1038/mp.2014.154. Epub 2014 Nov 25.

Trevor A. Hurwitz., et al., Bilateral anterior capsulotomy for intractable depression. J Neuropsychiatry Clin Neurosci 2012.24(2): p. 176-182

Andrade, P., et al., Neurostimulatory and ablative treatment options in major depressive disorder: a systematic review. Acta Neurochir, 2010.152: p. 565-577.

M. Sam Eljamel, et al., Ablative neurosurgery for mental disorder: is there still a role in the 21st century? A personal perspective. Neurosurg Focus, 2008. 25(1): p.1-6

Click here for additional references from PubMed.

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