Occipital Nerve Stimulation (ONS) involves delivering small electrical impulses to the occipital nerve. Insulated lead wires are advanced through a needle until they are adjacent to the nerve. The leads are then tunneled to a site, usually under the collarbone, and connected to a small implanted pulse generator. It is theorized that ONS interferes with pain transmission to the brain.

This therapy is being researched for occipital neuralgia, chronic headaches and migraines that are refractory to medical treatments.

Investigational and Not Medically Necessary: 

Occipital nerve stimulation is considered investigational and not medically necessary for all indications.

ONS is accomplished via a modified device that is related to the spinal cord stimulator and is one type of implantable pulse generators (IPG). Electrical stimulation is applied to the occipital nerve, which arises from the second cervical vertebral area and then branches out across the back of the head carrying sensory signals from that region to the brain. Pain conditions (e.g. migraines and chronic headaches) are currently treated with medications and anesthetic blocks. While this type of treatment may work in some instances, pain relief is short lived or not relieved in some individuals. For this group, research using electrical stimulation is being conducted to establish whether this application is efficacious and safe.

Burns and colleagues (2008) studied fourteen individuals with medically intractable chronic cluster headaches (CCH). Participants were implanted with bilateral electrodes in the suboccipital region for occipital nerve stimulation (ONS). Twelve individuals used the stimulation continuously while two used it intermittently. A retrospective assessment of their clinical outcome was obtained. At a median follow-up of 17.5 months (range 4–35 months), 10 of 14 participants reported improvement and 9 of these recommend ONS. Three participants noticed a marked improvement of 90% or better (90%, 90%, and 95%), 3 a moderate improvement of 40% or better (40%, 50%, and 60%), and 4 a mild improvement of 20–30% (20%, 20%, 25%, and 30%). Improvement occurred within days to weeks for those who responded most and participants consistently reported their attacks returned within hours to days when the device was off. One participant found that ONS helped abort acute attacks. Adverse events of concern were lead migrations and battery depletion. The authors concluded that ONS offers a safe, effective option for some individuals with CCH, however more research is required to evaluate safety and efficacy of this therapy.

Schwedt and colleagues (2007) performed a retrospective analysis of 15 individuals with medically refractory headache treated with occipital nerve stimulation. Pre- and post implant data regarding headache frequency, severity, disability, depression and poststimulator complications were collected. Twelve individuals were female and three male. Ages ranged from 21 to 52 years (mean 39 years). Eight  individuals had chronic migraine, three chronic cluster, two hemicrania continua and two had post-traumatic headache. Eight individuals underwent bilateral and seven had unilateral lead placement. Individuals were measured after 5-42 months (mean 19). All six mean headache measures improved significantly from baseline (P < 0.03). Headache frequency per 90 days improved by 25 days from a baseline of 89 days; headache severity (0-10) improved 2.4 points from a baseline of 7.1 points; migraine disability assessment (MIDAS) improved 70 points from a baseline of 179 points; Headache Impact Test™ HIT-6 scores improved 11 points from a baseline of 71 points; Beck Depression Inventory (BDI-II) improved eight points from a baseline of 20 points; and the mean subjective percent change in pain was 52%. Most individuals (60%) required lead revision within 1 year. One individual required generator revision. Occipital nerve stimulation may be effective in some individuals with intractable headache. The authors determined that further well-designed clinical studies are necessary for individuals with medically refractory headache.

The ONS device does not have U.S. Food and Drug Administration (FDA) approval at this time. Currently, clinical trials are underway for two ONS devices: ONSTIM^® (Medtronic Neuro) and PRISM^® (Boston Scientific Corporation) to establish safety and efficacy of ONS for migraine headaches.

Occipital nerve stimulation may be effective for the treatment of medically intractable headache, because electrical stimulation of large sensory afferents generally has an antinociceptive effect, where the electrical stimulus interferes with the neural transmission of the pain sensations back to the brain are decreased or obliterated. Neural electrical stimulation has been used in other modalities for treatment of pain that includes implanted and non implanted lead wires/devices. The ONS device is implanted and requires surgery for placement of the lead wires that deliver the electrical stimulus and placement of the pulse generator. The therapy is not without difficulties. Lead migration is the most frequent problem, requiring removal and replacement. Power depletion in the pulse generator also needs to be addressed. As with all surgery, the possibility of infection has to be considered.  

Afferent: A nerve that carries impulses toward the central nervous system (CNS); the opposite of an afferent nerve is an efferent nerve that carries impulses away from the CNS.

Cluster Headaches: Sudden, intensely painful headaches that occur repeatedly in groups or clusters.

Intractable: Having no relief, such as a symptom or a disease that is not relieved by the therapeutic measures. 

Migraine: A vascular headache believed to be caused by blood flow changes and certain chemical changes in the brain leading to a cascade of events that include constriction of arteries supplying blood to the brain that result in severe head pain, stomach upset, and visual disturbances.

Nociceptive: Causing pain.

The following codes for treatments and procedures applicable to this document are included below for informational purposes.  A draft of future ICD-10 Coding (effective pending final Health and Human Services [HHS] compliance date) related to this document, as it might look today, is included below for your reference.  Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy.  Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services are Investigational and Not Medically Necessary:
For the following codes when describing an occipital nerve stimulator, or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

Peer Reviewed Publications:

1. Burns B, Watkins L, Goadsby P. Treatment of intractable chronic cluster headache by occipital nerve stimulation in 14 patients.  Neurology. 2009; 72(4):341-345. 
2. Burns B, Watkins L, Goadsby PJ. Treatment of medically intractable cluster headache by occipital nerve stimulation: long-term follow-up of eight patients. Lancet. 2007; 369(9567):1099-1106.
3. Johnstone CSH. Occipital nerve stimulation for the treatment of occipital neuralgia – eight case studies. Neuromodulation. 2006; 9(1):41-47.
4. Magis D, Allena M, Bolla M, et al. Occipital nerve stimulation for drug-resistant chronic cluster headache: a prospective pilot study. Lancet Neurology. 2007; 6(4):314-321.
5. Schwedt T. Occipital nerve stimulation for medically intractable headache. Current Pain and Headache Reports. 2008; 12(1):62-66.
6. Schwedt TJ, Dodick DW, Hentz J, et al. Occipital nerve stimulation for chronic headache – long-term safety and efficacy. Cephalalgia. 2007; 27(2):153-157.

Government Agency, Medical Society, and Other Authoritative Publications: 

1. Boston Scientific. A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial of Occipital Nerve Stimulation for Drug Refractory Migraine. NLM Identifier: NCT00747812. Last updated on September 01, 2011. Available at: http://www.clinicaltrials.gov/ct2/show/NCT00747812?term=occipital+nerve+stimulation+migraine&rank=3  Accessed on February 07, 2012.
2. Medtronic Neuro. ONSTIM: Occipital Nerve Stimulation for the Treatment of Intractable Migraine. NLM Identifier:  NCT00200109. Last updated on October 07, 2011, . Available at: http://www.clinicaltrials.gov/ct2/show/NCT00200109?term=occipital+nerve+stimulation+migraine&rank=1  Accessed on February 07, 2012.

Migraine
ONSTIM^®
PRISM^®

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