The National Institute for Health and Care Excellence (NICE), United Kingdom, published its first guidelines on March 23, 2016, for the use of transcutaneous stimulation of cervical branches of the vagus nerve for the treatment of cluster headaches and migraine. The following recommendations are described:

Current data regarding the safety of transcutaneous stimulation of vagus nerve branches in the neck for the treatment of cluster headaches and migraines do not indicate major safety concerns. However, the evidence of efficacy is limited in scope and quality. For this reason, the procedure should only be performed with specific precautions for clinical monitoring, informed consent, verification of use, or within the context of research projects.

Clinically active physicians who intend to use the procedure should pay particular attention to the following guidelines:

  • Information from the clinical monitoring authority of your health district
  • Ensure that patients understand the uncertainty of the procedure regarding its effectiveness and are provided with clear written information about it.
  • Follow-up monitoring and monitoring of clinical outcomes of patients using transcutaneous stimulation of branches in the neck region of the vagus nerve for the treatment of cluster headaches and migraines.

NICE reaffirms the need for further research into transcutaneous stimulation of cervical branches of the vagus nerve for the treatment of cluster headaches and migraine.

In summary, NICE confirms that there is no good evidence regarding the effectiveness of transcutaneous stimulation of cervical branches of the vagus nerve in treating cluster headaches and migraines. The procedure should only be used if special precautions are taken to explain the risks to patients. Specific steps should be implemented to ensure close monitoring of the course of treatment and to closely track the treatment progress. Further research is needed, and NICE will reassess the procedure when more data become available. NICE points out that the procedure's effectiveness is uncertain and it is unclear whether it improves symptoms. Patients should be thoroughly informed about this.

Current data suggests that the treatment for cluster headaches has a higher probability of effectiveness compared to migraine treatment. However, when evaluating the data, it must be considered that the spontaneous course of active cluster periods is limited in duration. Active cluster periods last between 4 and 8 weeks and then subside spontaneously. Anecdotal evidence could lead to the unfounded conclusion that a particular treatment is responsible for the resolution of attacks. This misinterpretation of treatment effectiveness also applies to many other therapeutic options used for cluster headaches. These include, for example, septoplasty, sinus surgery, tooth extraction, and others.

GammaCore, a transcutaneous stimulation of cervical branches of the vagus nerve used in the treatment of cluster headaches and migraines, is not a standard benefit covered by German health insurance. The monthly cost for a maximum of 300 treatments is approximately €260. The procedure is not recommended in current German guidelines for the treatment of migraines and cluster headaches.