DESCRIPTION
Cranial electrotherapy stimulation (CES) (e.g., transcranial electrical stimulation, cranial transcutaneous electrical nerve stimulation (TENS), neuroelectric therapy, or electrosleep) is a noninvasive procedure intended for the treatment of anxiety, depression, and insomnia. Low levels of electrical current are applied via electrodes clipped onto the ear lobes or attached behind the ears. CES is thought to have a direct effect on the brain's limbic system, hypothalamus, and/or reticular activation system. It has also been suggested that CES may activate the parasympathetic autonomic nervous system by stimulating the vagus nerve. Individuals remain in a relaxed but mentally alert state.
Transcranial magnetic stimulation (TMS) is a related but distinctive noninvasive procedure intended for the treatment of depression using an electromagnetic field, instead of direct electrical current. A crescent shaped magnet is placed over the prefrontal cortex, transmitting magnetic pulses through the skull penetrating into the brain to a maximum depth of about 2 cm. The pulses are intended to stimulate brain cells by creating a low-energy electric field. The individual remains awake, with no sedation or anesthesia. TMS is distinguished from electroconvulsive therapy (ECT) in that it may not be necessary to induce seizures for TMS to exert an effect on depression, although the procedure may induce seizures.
POLICY
Cranial electrotherapy stimulation as a treatment for depression and other psychiatric disorders is considered investigational.
Transcranial magnetic stimulation as a treatment for depression and other psychiatric disorders is considered investigational.
ADDITIONAL INFORMATION
There is insufficient evidence to establish the efficacy of cranial electrotherapy stimulation or transcranial magnetic stimulation in the treatment of depression or other psychiatric disorders.
SOURCES
BlueCross BlueShield Association. Medical Policy Reference Manual. (12:2008). Transcranial magnetic stimulation as a treatment of depression and other psychiatric/neurologic disorders. (2.01.50). Retrieved May 15, 2009 from BlueWeb. (35 articles and/or guidelines reviewed)
Borckardt, J. L., l Weinstein, M., Reeves, S. T., Kozel, A., Nahas, Z., Smith, A. R., et al. (2006). Postoperative left prefrontal repetitive transcranial magnetic stimulation reduces patient-controlled analgesia use. Anesthesiology, 105 (3), 557-562. (Level 4 Evidence - Independent study)
Code of Federal Regulations. Title 21, Volume 8. (2008, April). Section 882.5800. Neurological devices. Retrieved May 15, 2009 from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?FR=882.5800.
Complete Guide to Medicare Coverage Issues [Computer software]. (2009, April). Electrosleep therapy-not covered (NCD 30.4, p. 2-31). The Ingenix Complete Guide to Medicare Coverage Issues.
Eraqnti, S., Mogg, A., Pluck, G., Landau, S., Purvis, R., Brown, R. G., et al. (2007). A randomized controlled trial with 6-month follow-up of repetitive transcranial magnetic stimulation and electroconvulsive therapy for severe depression. American Journal of Psychiatry, 164 (1), 73-81. (Level 2 Evidence - Independent study)
Fitzgerald, P. B., Benitez, J., de Castella, A., Daskalakis, Z. J., Brown, T. L., & Kulkarni, J. (2006). A randomized, controlled trial of sequential bilateral repetitive transcranial magnetic stimulation for treatment-resistant depression. American Journal of Psychiatry, 163 (1), 88-94. (Level 2 Evidence - Independent study)
Gilula, M. F. & Kirsch, D. L. (2005). Cranial electrotherapy stimulation review: A safer alternative to psychopharmaceuticals in the treatment of depression. Journal of Neurotherapy, 9 (2), 7-26.
Hayes. Medical Technology Directory. (2007, December). Transcranial magnetic stimulation for major depression. Retrieved May 15, 2009 from www.Hayesinc.com/subscribers. (52 articles and/or guidelines reviewed)
Kirsch, D. L., & Gilula, M. F. (2007). CES in the treatment of anxiety disorders. A review and meta-analysis of cranial electrotherapy stimulation (CES) in the treatment of anxiety disorders - Part 1. Practical Pain Management, 7 (2), 40-47. (Level 4 Evidence - Industry sponsored)
Kirsch, D. L., & Gilula, M. F. (2007). CES in the treatment of anxiety disorders - Part 2. Statistical considerations in the meta-analysis of cranial electrotherapy stimulation (CES) in the treatment of anxiety disorders. Practical Pain Management, 7 (3), 22-39.
Kirsch, D. L., & Gilula, M. F. (2007). CES in the treatment of depression. Practical Pain Management, 7 (4), 33-41.
Kirsch, D. L., & Gilula, M. F. (2007). CES in the treatment of depression - Part 2. Practical Pain Management, 7 (5), 32-40.
Kirsch, D. L., & Gilula, M. F. (2007). CES in the treatment of insomnia: A review and meta-analysis. Practical Pain Management, 7 (7), 28-39. (Level 4 Evidence - Industry sponsored)
Kirsch, D. L., & R. B. Smith. (2004). Cranial electrotherapy stimulation for anxiety, depression, insomnia, cognitive dysfunction, and pain: A review and meta-analyses. In P. J. Rosch, & M. S. Markov (Eds.), Bioelectromagnetic medicine (pp. 727-740). New York: Mark Dekker, Inc.
Kirton, A., deVeber, G., Gunraj, C., & Chen, R. (2008). Case reports. Neurocardiogenic syncope complicating pediatric transcranial magnetic stimulation. Pediatric Neurology, 39 (3), 196-197.
Lam, R. W., Chan, P., Wilkins-Ho, M., & Yatham, L. N. (2008). Repetitive transcranial magnetic stimulation for treatment-resistant depression: A systematic review and metaanalysis. The Canada Journal of Psychiatry, 53 (9), 621-631. (Level 1 Evidence - Industry sponsored)
National Guideline Clearinghouse. (2006, March). Depression clinical practice guidelines. Retrieved May 15, 2009 from http://www.guidelines.gov.
National Guideline Clearinghouse. (2007). Practice guideline for the treatment of patients with obsessive-compulsive disorder. Retrieved May 15, 2009 from http://www.guidelines.gov.
National Guideline Clearinghouse. (2007). Practice parameters for the assessment and treatment of children and adolescents with depressive disorders. Retrieved May 15, 2009 from http://www.guidelines.gov.
National Guideline Clearinghouse. (2008, May). Major depression in adults in primary care. Retrieved May 15, 2009 from http://www.guidelines.gov.
National Institute for Health and Clinical Excellence (NICE). (2007, November). Transcranial magnetic stimulation for severe depression. Retrieved May 15, 2009 from http://www.nice.org.uk/guidance/IPG242/Guidance/pdf/English.
U. S. Food and Drug Administration. (2006, October). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K060158. Retrieved May 18, 2009 from http://www.fda.gov/cdrh/pdf6/K060158.pdf.
U. S. Food and Drug Administration. (2007, April). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K062284. Retrieved May 15, 2009 from http://www.fda.gov/cdrh/pdf6/K062284.pdf.
U. S. Food and Drug Administration. (2007, January). Center for Devices and Radiological Health. Brief Summary from the Neurological Devices Panel Meeting-January 26, 2007. Retrieved April 9, 2007 from http://www.fda.gov/cdrh/panel/summary/neuro-012607.html.
ORIGINAL EFFECTIVE DATE: 8/13/2005
MOST RECENT REVIEW DATE: 6/11/2009
ID_BT
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