Occipital Nerve Stimulation
The occipital nerve stimulation (ONS) device (Synergy™ IPG, Genesis™ Neuromodulation System) 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.
Recently introduced to the market are non-invasive hand-held devices that stimulate the occipital cortex (e.g., SpringTMS®) by means of a brief pulse of magnetic energy, inducing an electrical current. The intent of this stimulation to the occipital cortex is to stop or lessen migraine headaches.
There are four types of headache: vascular, muscle contraction (tension), traction, and inflammatory. Primary (not the result of another condition) chronic headache is defined as a headache occurring more than 15 days of the month for at least 3 months.
Migraine is the most common type of vascular headache. Migraine headaches 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.
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.
Occipital nerve stimulation for all indications is considered investigational.
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In December 2013, a device known as Cerena™ transcranial magnetic stimulator by eNeura Therapeutics® was the first device to receive marketing approval from the FDA for the treatment of migraines. This device was portable, hand-held, and AC-powered, delivering a brief pulse of magnetic energy to the back of the head to induce an electrical current to the occipital cortex. For this device and all occipital nerve stimulation devices randomized controlled trials are needed to compare outcomes between occipital nerve stimulation and comparators (eg, to control for a potential placebo effect) to establish safety and effectiveness.
BlueCross BlueShield Association. Evidence Positioning System. (4:2018). Occipital nerve stimulation (7.01.125). Retrieved March 26, 2018 from http://www.evidencepositioningsystem.com. (15 articles and/or guidelines reviewed)
Chen, Y.F., Bramley, G., Unwin, G., Hanu-Cernat, D., Dretzke, J., Moore, D., et al. (2015). Occipital nerve stimulation for chronic migraine - a systematic review and meta-analysis. PLoS One, 10 (3), e0116786. (Level 1 evidence)
Congress of Neurological Surgeons. (2015, September). Occipital nerve stimulation for the treatment of patients with medically refractory occipital neuralgia. Retrieved May 4, 2016 from http://www.guideline.gov. (NGC: 010801).
Magis, D., Bruno, M. A., Fumal, A., Gérardy, P. Y., Hustinx, R., Laureys, S., et al. (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)
Miller, S., Watkins, L., & Matharu, M. (2016). Long-term outcomes of occipital nerve stimulation for chronic migraine: a cohort of 53 patients. Journal of Headache Pain, 17 (1), 1-14. (Level 4 evidence - Industry sponsored)
Miller, S., Watkins, L., & Matharu, M. (2017). Treatment of intractable chronic cluster headache by occipital nerve stimulation: a cohort of 51 patients. European Journal of Neurology, 24 (2), 381-390. Abstract retrieved March 9, 2017 from PubMed database.
National Institute for Health and Care Excellence. (2013, April). Occipital nerve stimulation for intractable chronic migraine. Retrieved March 9, 2017 from www.nice.org.uk/guidance.
Rodrigo, D., Acin, P., & Bermejo, P. (2017). Occipital nerve stimulation for refractory chronic migraine: results of a long-term prospective study. Pain Physician, 20 (1), E151-E159. Abstract retrieved March 9, 2017 from PubMed database.
Saper, J., Dodick, D., Silberstein, S., McCarville, S., Sun, M. & Goadsby, P. (2010, June). Occipital nerve stimulation for the treatment of intractable chronic migraine headache: ONSTIM feasibility study. Cephalalgia, 31 (3), 271-285. (Level 2 evidence)
U. S. Food and Drug Administration. (2013, December). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K130556. Retrieved March 13, 2017 from http://www.accessdata.fda.gov.
U. S. Food and Drug Administration. (2014, May). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K140094. Retrieved March 13, 2017 from http://www.accessdata.fda.gov.
ORIGINAL EFFECTIVE DATE: 9/12/2010
MOST RECENT REVIEW DATE: 4/11/2019
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