Occipital Nerve Stimulation
DESCRIPTION
The occipital nerve stimulation (ONS) device delivers a small electrical charge to the occipital nerve in an attempt to prevent migraines and other headaches in individuals who have not responded to medications. The device consists of a subcutaneously implanted pulse generator (in the chest wall or abdomen) attached to extension leads that are tunneled to join electrodes placed across one or both occipital nerves at the base of the skull. Continuous or intermittent stimulation may be used. Implanted peripheral nerve stimulators have been used for treatment of refractory pain for many years but only recently proposed for management of craniofacial pain.
There are four types of headaches: vascular, muscle contraction (tension), traction, and inflammatory.
Primary (not the result of another condition) chronic headaches are defined as a headache occurring more than 15 days of the month for at least 3 months.
The migraine headache is the most common type of vascular headache. They are usually characterized by severe pain on one or both sides of the head, an upset stomach, and, at times, disturbed vision. One-year prevalence of migraine ranges from 6%-15% in adult men and from 14%-35% in adult women. Migraine headaches may last a day or more and can strike as often as several times a week or as rarely as once every few years.
Hemicrania continua is another type of vascular headache, which causes moderate pain with occasional severe pain on only one side of the head. At least one of the following symptoms must also occur; conjunctival injection and/or lacrimation, nasal congestion and/or rhinorrhea, or ptosis and/or miosis. The headaches occur daily and are continuous with no pain-free periods. Hemicrania continua headaches occur mainly in woman, and its true prevalence is not known.
A cluster headache is a vascular headache that occurs in cyclical patterns or clusters of severe or very severe unilateral orbital or supraorbital and/or temporal pain. The headache is accompanied by at least one of the following autonomic symptoms: ptosis (drooping eyelid), conjunctival injection, lacrimation, rhinorrhea, and, less commonly, facial blushing, swelling, or sweating. Bouts of one headache every other day to 8 attacks per day may last from weeks to months, usually followed by remission periods when the headache attacks stop completely. The pattern varies from one person to another, but most people have one or two cluster periods a year. During remission, no headaches occur for months, and sometimes even years. The intense pain is caused by the dilation of blood vessels, which creates pressure on the trigeminal nerve. While this process is the immediate cause of the pain, the etiology is not fully understood. It is more common in men than in woman.
POLICY
Occipital nerve stimulation for all indications is considered investigational.
See also:
Vagus Nerve Stimulation for the Treatment of Depression
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
ADDITIONAL INFORMATION
As of February 2012, the U.S. Food and Drug Administration (FDA) had not published any approvals for occipital nerve stimulation device for the treatment of headaches.
According to the ClinicalTrials.gov in September 2009, a number of clinical trials were underway. However, randomized controlled trials with greater numbers of individuals and longer follow-up are needed. In addition, these trials must compare outcomes of occipital nerve stimulation with outcomes of other possible alternative treatments.
SOURCES
BlueCross BlueShield Association. Medical Policy Reference Manual. (11:2011). Occipital nerve stimulation (7.01.125). Retrieved February 3, 2012 from BlueWeb. (9 articles and/or guidelines reviewed)
Burns, B., Watkins, L., & Goadsby, P. J. (2008). Treatment of hemicrania continua by occipital nerve stimulation with a bion device: Long-term follow-up of a crossover study. Lancet Neurology, 7 (11), 1001-1012. (Level 4 Evidence - Industry sponsored)
Dafer, R. M. (2010). Neurostimulation in headache disorders. Neurologic Clinics, 28 (4), 835-841.
Goadsby, P. J. & Sprenger, T. (2010). Current practice and future directions in the prevention and acute management of migraine. Lancet Neurology, 9 (3), 285-298.
Jasper, J. F., & Hayek, S. M. (2008). Implanted occipital nerve stimulators. Pain Physicians, 11 (2), 187-200.
Leroux, E., & Ducros, A. (2008). Cluster headache. Orphanet Journal of Rare Diseases, 3 (20).
Magis, D., Bruno, M. A., Fumal, A., Gerardy, P. Y., Hustinx, R., Laureys, S., & Schoenen, J. (2011). Central modulation in cluster headache patients treated with occipital nerve stimulation: An FDG-PET study. BMC Neurology, 11, (25), 1-9. (Level 4 Evidence - Industry sponsored)
National Institute for Health and Clinical Excellence. (2008, April). Interventional procedures programme. Interventional procedure overview of occipital nerve stimulation for intractable headache. Retrieved February 6, 2012 from http://www.nice.org.uk/nicemedia/live/11933/41370/41370.pdf.
Saper, J. R., Dodick, D. W., Silberstein, S. D., McCarville, S., Sun, M., & Goadsby, P. J. for the ONSTIM Investigators. Occipital nerve stimulation for the treatment of intractable chronic migraine headache: ONSTIM feasibility study. Cephalalgia, 31 (3), 271-285. (Level 2 Evidence - Industry sponsored)
Strand, N. H., Trentman, T. L., Vargas, B. B., & Dodick, D. W. (2011). Occipital nerve stimulation with the BionŽ microstimulator for the treatment of medically refractory chronic cluster headache. Pain Physician, 14 (5), 435-440.
Trentman, T. L., Rosenfeld, D. M., Vargus, B. B., Schwedt, T. J., Zimmerman, R. S., & Dodick, D. W. (2009). Greater occipital nerve stimulation via the Bion microstimulator: Implantation technique and stimulation parameters. Clinical trial: NCT00205894. Pain Physician, 12 (3), 621-628. (Level 4 Evidence - Industry sponsored)
ORIGINAL EFFECTIVE DATE: 9/12/2010
MOST RECENT REVIEW DATE: 3/8/2012