Occipital nerve stimulation

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Occipital nerve stimulation (ONS) , also called peripheral nerve stimulation (PNS) of the occipital nerves , is used to treat patients with chronic migraines or cluster headache who no longer respond to pharmaceutical treatment options.

The therapy uses electrical impulses to stimulate the major occipital nerve and minor occipital nerve , which are components of the peripheral nervous system . These are located on the occiput, directly above the neck area.

The electrical impulses are generated by a so-called neurostimulator - a small generator similar to an artificial pacemaker . Possible implantation sites can be: in the buttocks, chest , lower abdomen , under the shoulder blade or collarbone . The electricity is conducted to the major occipital and minor occipital nerves by means of small metallic contacts which are arranged on thin cables (also called electrodes) and are implanted directly under the skin. The intensity of the electrical impulses can be controlled with a handheld remote control.

history

The history of the PNS is discussed in detail in a publication by Slavin, 2011. The use of peripheral nerve stimulation for chronic pain was first reported by Wall and Sweet in 1967, although the first implantations were performed by Shelden in 1962. These have proven that electrical stimulation of the peripheral nerves suppresses the perception of pain. A phase of semi-experimental PNS use continued for another 15–20 years. In the second half of the 1980s, PNS established itself as a surgical procedure. In the late 1990s, Weiner and Reed reported the percutaneous method, which uses the contacts near the occipital nerves to treat occipital neuralgia. Weiner has shown that placing an electrode for the PNS near a nerve is effective for pain management and is also a surgically and technically simple procedure. This pioneering work ushered in the dawn of the modern age of PNS. It was in 2003 when Popeney and Aló proposed the use of PNS for the treatment of chronic migraines . Then were randomized controlled prospective studies initiated to provide additional clinical evidence to create.

In September 2011, St. Jude Medical was the first provider worldwide to receive a European approval ( CE mark ) for the treatment of chronic therapy-resistant migraines with the help of PNS.

Therapy candidates

Suitable patients with PNS of the occipital nerve for the treatment of chronic migraines must have a chronic migraine that has been classified as therapy-resistant (therapy-resistant).

Chronic migraine is defined in the International Headache Society (IHS) guidelines as follows:

  • 15 or more migraine headache days (without aura ) per month for more than 3 months with headache lasting at least 4-72 hours.
  • At least two of the following characteristics must apply: one-sided localization, pulsating character, moderate or severe pain intensity, reinforcement or avoidance of this through routine physical activities (e.g. walking or climbing stairs).
    • During the headache, one or more of the following symptoms are present: nausea and / or vomiting , photophobia and phonophobia.
  • Not due to any other illness.
  • No drug overuse (overuse of analgesics ).

Therapy-refractory chronic migraine is generally defined as follows: Chronic migraines with little or no relief from at least three different or combined preventive drugs or unreasonable side effects of these drugs and at least a moderate, functional impairment according to a recognized assessment instrument for migraines (e.g. MIDAS or HIT-6).

Procedure

Preoperatively

Prior to implantation, patients usually undergo a psychological assessment to determine their well-being and mental state. The procedural risks are discussed and patients are asked for their informed consent . The risks of the intervention can a. The following include: No guarantee of effectiveness, risk of infection, nerve damage, painful direct muscle stimulation, electrode displacement with loss of stimulation, electrode breakage, battery failure and the resulting change of neurostimulator , hematoma and seroma formation .

implantation

In most cases (country-specific differences), a trial (test) electrode placement is performed to determine whether the stimulation will work as intended. A local anesthetic is administered to the back of the neck and an epidural cannula is advanced to the location of the major occipital and minor occipital nerves under fluoroscopic guidance . Once the implantation site is defined, a trial electrode is placed through the cannula before carefully removing the cannula. Electrical impulses are sent through the electrode and its position is continuously adjusted until the patient reports a “tingling sensation”, also called paresthesia , over the nerve areas. If paresthesia is successfully achieved in the right place, permanent electrodes are usually implanted at a later time. In some cases, the trial electrodes are left in the body for up to a week to see if symptoms have been relieved .

The placement of the permanent electrodes can be done either under general anesthesia or under local anesthesia with sedation. First, a small incision is made at the base of the skull, then an epidural cannula is pushed under fluoroscopic guidance to the location of the major occipital nerve and minor occipital nerve on one side of the head. Once the electrode is properly positioned under fluoroscopic guidance , the electrode is placed permanently. Since most patients need two electrodes, a second electrode is usually placed on the other side of the head and fixed in place in the same way. In the following step, the electrode (s) are tunneled to the neurostimulator , which is usually implanted in the buttocks, chest , lower abdomen , under the shoulder blade or collarbone .

Clinical proof

Results of three randomized controlled trials have been published so far. A randomized controlled study in 157 patients with chronic migraines was first reported as a summary in June 2011. The data were published in a scientific journal in October 2012. The participants were provided with the neurostimulator and then randomized . The neurostimulator was either switched on (treatment group) or switched off ( control group ) over a period of 12 weeks . After week 12, all participants received active treatment ( stimulation ) up to week 52. All participants received trial stimulation to ensure the correct placement of the contacts. A total of 153 participants completed the study (52 weeks). There was a statistically significant difference (p <0.05) between the number of patients in the treatment group compared to the control group with 30 percent pain reduction using the visual analog scale (VAS). The study also showed that the treatment group ( neurostimulator switched on) had an average of 6.1 (27.2%) fewer monthly headache days. This result is statistically significant (p <0.001), since it was more than twice the average reduction compared to the control group ( neurostimulator switched off) (3.0 days; 14.9%). The clinical study researchers reported that the rate of Serious Device and Procedure Related Adverse Events was 1.0%. Furthermore, they each included one case of infection and one of postoperative pain , which required additional hospitalization.

In February 2011, ONSTIM study researchers reported three month results from a randomized controlled trial of patients with chronic migraines . Participants first underwent an occipital nerve block. The participants who responded to this treatment were then randomized into three groups. The first group was a treatment group (33 participants) and received adjustable stimulation. The other two groups were control groups and received ineffective stimulation (“sham” stimulation) for one minute per day or standard medical care (17 participants each). Patients who achieved at least a 50 percent reduction in the number of monthly headache days or - measured from baseline values ​​- a minimum reduction in the total average pain intensity of three points were defined as therapy responders. 39% of the patients in the adjustable stimulation group were responders , 6% in the sham stimulation group and 0% in the medical care group. The differences between the responder rates in the treatment group and the control groups were statistically significant . Other outcome measures such as the number of headache days were not statistically significant between the groups . Still, the percent reduction in headache days was 27% for the treatment group and less than 9% for each of the two control groups, which is a numerical advantage for the treatment group. No unexpected device-related complications were reported. Electrode shifts occurred in 24% of patients.

In December 2009, the PRISM study researchers reported a summary of three-month results from a randomized controlled trial of 125 patients with chronic migraines . The patients were randomized into two groups. Group one was a treatment group with active stimulation. The second was the control group and received sham stimulation. In the patients in the treatment group, the monthly number of migraine days was reduced by 5.5 days from a starting value of 20.2 days per month. In the patients in the control group, the monthly number of migraine days was reduced by 3.9 days from a starting value of 19.2 days per month. The difference between the two groups was not statistically significant . Nevertheless, there was a tendency towards a greater difference between the two groups, provided that the patient had not previously had medication overuse.

Individual evidence

  1. ↑ a b c d e f g Trentman TL, Zimmerman RS, Dodick DW: Occipital Nerve Stimulation: Technical and Surgical Aspects of Implantation . In: Progress in Neurological Surgery . 24, 2011, pp. 96-108. doi : 10.1159 / 000323043 . PMID 21422780 .
  2. ↑ Slavin KV: Technical Aspects of Peripheral Nerve Stimulation: Hardware and Complications . In: Progress in Neurological Surgery . 24, 2011, pp. 189-202. doi : 10.1159 / 000323275 . PMID 21422789 .
  3. ^ Slavin KV: History of peripheral nerve stimulation . In: Progress in Neurological Surgery . 24, 2011, pp. 1-15. doi : 10.1159 / 000323002 . PMID 21422772 .
  4. ↑ St Jude press release . St. Jude Medical Inc .. Archived from the original on January 5, 2013. Information: The archive link was automatically inserted and has not yet been checked. Please check the original and archive link according to the instructions and then remove this notice. Retrieved August 8, 2012. @1@ 2Template: Webachiv / IABot / investors.sjm.com
  5. ^ The International Classification of Headache Disorders, 2nd Edition, 1st revision (May, 2005) . Retrieved October 15, 2013.
  6. ↑ Silberstein SD, Dodick DW, Pearlman S: Defining the pharmacologically intractable headache for clinical trials and clinical practice . In: Headache . 50, No. 9, 2010, pp. 1499-506. doi : 10.1111 / j.1526-4610.2010.01764.x . PMID 20958296 .
  7. ↑ a b c d e f g h i AIó KM, Abramovac MV, Richtef EO: Percutaneous Peripheral Nerve Stimulation . In: Progress in Neurological Surgery . 24, 2011, pp. 41-S7. doi : 10.1159 / 000323023 . PMID 21422775 .
  8. ↑ a b c d e f Ellens DJ, Levy RM: Peripheral Neuromodulation for Migraine Headache . In: Progress in Neurological Surgery . 24, 2011, pp. 109-117. doi : 10.1159 / 000323890 . PMID 21422781 .
  9. ↑ a b c d e Trentman TL, Slavin KV, Freeman JA, Zimmerman RS: Occipital Nerve Stimulator Placement via a Retromastoid to Infraclavicular Approach: A Technical Report . In: Stereotactic and Functional Neurosurgery . 88, No. 2, 2010, pp. 121-125. doi : 10.1159 / 000289356 . PMID 20197713 .
  10. ↑ Silberstein SD, Dodick DW, Saper J, Huh B, Reed K, Narouze S, Bacon D, Mogilner A, Banks J, Cady R, Black S, Slavin KV, Goldstein J, Markley H, Deer T, Levy R, Mekhail N: Safety and Efficacy of Peripheral Nerve Stimulation of the Occipital Nerves for the Management of Chronic Migraine . In: 15th Congress of the International Headache Society, Berlin, Germany . June 2011.
  11. ↑ Silberstein SD, Dodick DW, Saper J, Huh B, Slavin KV, Sharan A, Reed K, Narouze S, Mogilner A, Goldstein J, Trentman T, Vaisma J, Ordia J, Weber P, Deer T, Levy R, Diaz RL, Washburn SN, Mekhail N: Safety and Efficacy of Peripheral Nerve Stimulation of the Occipital Nerves for the Management of Chronic Migraine: Results from a Randomized, Multicenter, Double-blinded, Controlled Study . In: Cephalalgia . [Epub ahead of print] October 2012. PMID 23034698 .
  12. ↑ Saper JR, Dodick DW, Silberstein SD, McCarville S, Sun M, Goadsby PJ: Occipital nerve stimulation for the treatment of intractable chronic migraine headache: ONSTIM feasibility study . In: Cephalalgia . 31, No. 3, 2011, pp. 271-85. doi : 10.1177 / 0333102410381142 . PMID 20861241 . PMC 3057439 (free full text).
  13. ↑ Infiltration therapy for cluster headache at ck-wissen.de
  14. Jump up ↑ Lipton RB, Goadsby PJ, Cady RK, Aurora SK, Grosberg BM, Freitag FG, Silberstein SD, Whiten DM, Jaax KN: PRISM study: Occipital nerve stimulation for treatment-refractory migraine . In: Headache . 50, No. 3, 2010, pp. 509-519. doi : 10.1111 / j.1526-4610.2010.01615.x . PMID 20456145 .
  15. ^ Abstracts for the 14th Congress of the International Headache Conference, Philadelphia, USA, 10-13 September 2009 . Retrieved October 15, 2013.
  16. ^ Diener HC, Dodick DW, Goadsby PJ, Lipton RB, Olesen J: Chronic migraine — classification, characteristics and treatment . In: Nat. Rev. Neurol . 8, 2012, pp. 162-171. doi : 10.1038 / nrneurol.2012.1 . PMID 22331030 .