BlueCross BlueShield of Tennessee Medical Policy Manual

Cranial Electrotherapy Stimulation and Navigated Transcranial Magnetic Stimulation

DESCRIPTION

Cranial electrotherapy stimulation (CES) also referred to as transcranial electrical stimulation, cranial transcutaneous electrical nerve stimulation, neuroelectric therapy, or electrosleep is a noninvasive procedure being evaluated as a treatment for a variety of conditions, including chronic pain, headache, insomnia, obesity, Parkinson’s Disease, Rheumatoid Arthritis, depression, and anxiety (e.g., Alpha-Stim®, Fisher Wallace Stimulator®). Low levels of direct electrical current are applied via electrodes clipped to the ear lobes or attached behind the ears. This device can be used in the home setting and proposes to stimulate the brain’s production of serotonin and other neurotransmitters that regulate mood. Treatments may last several hours and can be administered once or twice daily for a period of several days to several weeks.

Navigated transcranial magnetic stimulation (nTMS) is a noninvasive imaging method for the evaluation of brain functions, such as body movement and language (e.g., Nexstim® Navigated Brain Stimulation System).

Transcranial magnetic pulses are delivered to the individual as a navigation system calculates the strength, location, and direction of the stimulating magnetic field. Surface electromyography (EMG) electrodes are attached to the various limb muscles of the individual. Moving the magnetic stimulation source to various parts of the brain causes the EMG electrodes to respond, which indicates the part of the cortex involved in particular muscle movements. Surgical management of brain tumors necessitates ‘mapping’ to preserve brain tissue and essential brain function. However, this ‘mapping’ is considered to be most accurately achieved with direct cortical stimulation (DCS), done intraoperatively prior to the craniotomy.

POLICY

See also:

IMPORTANT REMINDERS

ADDITIONAL INFORMATION

The literature on cranial electrotherapy stimulation (CES) consists of a number of randomized controlled trials and systematic reviews, which provide little support for the efficacy of this treatment approach. Additional randomized studies with a larger number of subjects are needed to evaluate the efficacy of this treatment approach. Therefore, CES is considered investigational for all indications.

Overall, the literature on navigated transcranial magnetic stimulation (nTMS) is at a very preliminary stage of demonstrating effectiveness. Based on the limited evidence available and the results of clinical vetting, nTMS is considered investigational for all indications.

SOURCES

American Psychiatric Association (APA). (2015, October) Practice guidelines for the treatment of patients with major depressive disorder, third edition. Retrieved May 16, 2016 from www.guideline.gov. (NCG #008093)

BlueCross BlueShield Association. Medical Policy Reference Manual. (12:2015). Navigated transcranial magnetic stimulation (2.01.90). Retrieved May 16, 2016 from BlueWeb. (24 articles and/or guidelines reviewed)

BlueCross BlueShield Association. Medical Policy Reference Manual. (2:2016). Cranial Electrotherapy Stimulation and Auricular Electrostimulation(8.01.58). Retrieved May 16, 2016 from BlueWeb. (16 articles and/or guidelines reviewed)

California Technology Assessment Forum/Institute for Clinical and Economic Review (2014, June) Controversies in Migraine Management. Retrieved May 16, 2016 from: http://www.ctaf.org  (123 articles and/or guidelines reviewed)

Krieg, S. M., Sollmann, N., Hauck, T., Ille, S., Meyer, B., & Ringel, F. (2014). Repeated mapping of cortical language sites by preoperative navigated transcranial magnetic stimulation compared to repeated intraoperative DCS mapping in awake craniotomy. BMC Neuroscience, 15 (1), 20. (Level 3 evidence)

Paiva, W. S., Fonoff, E. T., Marcolin, M. A., Boar-Seng-Shu, E., Figueiredo, E. G., & Teixeira, M. J. (2013). Navigated transcranial magnetic stimulation in preoperative planning for the treatment of motor area cavernous angiomas. Neuropsychiatric Disease and Treatment, 9, 1885-1888. (Level 4 evidence)

Takahashi, S., Vajkocy, P., & Picht, T. (2013). Navigated transcranial magnetic stimulation for mapping the motor cortex in patients with rolandic brain tumors. Neurosurgical Focus, 34 (4), 1-7. (Level 5 evidence)

U. S. Food and Drug Administration. (2009, December). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K091875. Retrieved May 16, 2016 from http://www.accessdata.fda.gov.

U. S. Food and Drug Administration. (2011, September). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K112881. Retrieved May 16, 2016 from http://www.accessdata.fda.gov.

U. S. Food and Drug Administration. (2014, June). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K140788. Retrieved May 16, 2016 from http://www.accessdata.fda.gov.

ORIGINAL EFFECTIVE DATE:  8/13/2005

MOST RECENT REVIEW DATE:  12/21/2016

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Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.

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