Vagus Nerve Stimulation for the Treatment of Depression
DESCRIPTION
Implantation of a vagus nerve stimulator (VNS) is widely accepted for use as an adjunctive therapy in reducing the frequency of partial onset seizures, which are refractory to antiepileptic medications in adults and adolescents over 12 years of age. Since 1997, it has been reported that some recipients of a vagus nerve stimulator have experienced improvements in moods.
Studies are currently underway investigating the safety and efficacy of VNS in individuals with treatment-resistant depression. In these studies, participating individuals have a pacemaker-like pulse generator (e.g., the NCP® System) implanted under the skin of the upper left chest. A stimulation electrode extends from the chest to the neck where it is attached to the left vagus nerve. These studies are still in progress; thus, the safety and efficacy of VNS in the treatment of depression has not been established.
POLICY
Vagus nerve stimulation for the treatment of depression is considered investigational.
Policy with similar title: Vagus Nerve Stimulation for the Treatment of Medically Refractory Movement Disorders, Headaches and Obesity
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ADDITIONAL INFORMATION
Randomized, controlled studies in the published, peer-reviewed literature that validate the efficacy of vagus nerve stimulation for the treatment of depression are lacking. The FDA has approved the NCP® system for treatment of chronic refractory depression. However, well-designed studies are needed to fully document the value of vagus nerve stimulation in the treatment of depression.
SOURCES
Andrade, P., Noblesse, L. H., Temel, Y., Ackernans, L., Lim, L. W., Steinbusch, H. W., et al. (2010). Neurostimulatory and ablative treatment options in major depressive disorder: A systematic review. Acta Neurochirurgica, 152 (4), 565-577.
BlueCross BlueShield Association. Medical Policy Reference Manual. (11:2009). Vagus nerve stimulation (7.01.20). Retrieved March 3, 2011 from BlueWeb. (29 articles and/or guidelines reviewed)
Complete Guide to Medicare Coverage Issues [Computer software]. (2010, April). Vagus nerve stimulation for treatment of seizures (NCD 160.18, p. 2-80). Ingenix.
Dougherty, D. D. & Rauch, S. L. (2007). Somatic therapies for treatment-resistant depression: New neurotherapeutic interventions. Psychiatric Clinics of North America, 30 (1), 31-37.
ECRI Institute. Health Technology Information Service. Emerging Technology (TARGET) Evidence Report. (2008, December). Implantable vagus nerve stimulator for treatment - resistant depression. Retrieved March 4, 2011 from ECRI Institute. (19 articles and/or guidelines reviewed)
National Guidelines Clearinghouse. (2009, May). VA/DoD clinical practice guideline for management of major depressive disorder (MDD). Retrieved March 4, 2011 from http://www.guidelines.gov.
National Guidelines Clearinghouse. (2010, May). Major depression in adults in primary care. Retrieved March 4, 2011 from http://www.guidelines.gov.
National Guidelines Clearinghouse. (2010, October). Practice guideline for the treatment of patients with major depressive disorder, third edition. Retrieved March 4, 2011 from http://www.guidelines.gov.
National Institute for Health and Clinical Excellence (NICE). (2009, December). Vagus nerve stimulation for treatment-resistant depression. Retrieved March 4, 2011 from http://www.nice.org.uk/nicemedia/live/12149/46667/46667.pdf.
Pardo, J. V., Sheikh, S. A., Kuskowski, M. A., Surerus-Johnson, C., Hagen, M. C., Lee, J. T., et al. (2007). Weight loss during chronic, cervical vagus nerve stimulation in depressed patients with obesity: an observation. International Journal of Obesity, 31 (11), 1756-1759.
Shuchman, M. (2007). Approving the vagus-nerve stimulator for depression. The New England Journal of Medicine, 356 (16), 1604-1607.
Technology Evaluation Center. (2006, August). Vagus nerve stimulation for treatment-resistant depression (Vol. 21, No. 7). Chicago: BlueCross BlueShield Association. (52 articles and/or guidelines reviewed)
U. S. Food and Drug Administration. (2005, July). Center for Devices and Radiological Health. Medical devices. VNS therapy system - P970003s050. Retrieved July 5, 2002 from http://www.accessdata.fda.gov/cdrh_docs/pdf/p970003s050a.pdf.
Winifred S. Hayes, Inc. Medical Technology Directory. (2009, October). Vagus nerve stimulation for depression. Retrieved March 4, 2011 from www.Hayesinc.com/subscribers. (62 articles and/or guidelines reviewed)
ORIGINAL EFFECTIVE DATE: 7/1/2001
MOST RECENT REVIEW DATE: 4/14/2011
ID_BT
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