Abstract
The medical treatment of patients with chronic primary headache syndromes (chronic migraine, chronic tension-type headache, chronic cluster headache, hemicrania continua) is challenging as serious side effects frequently complicate the course of medical treatment and some patients may be even medically intractable. When a definitive lack of responsiveness to conservative treatments is ascertained and medication overuse headache is excluded, neuromodulation options can be considered in selected cases.Here, the various invasive and non-invasive approaches, such as hypothalamic deep brain stimulation, occipital nerve stimulation, stimulation of sphenopalatine ganglion, cervical spinal cord stimulation, vagus nerve stimulation, transcranial direct current stimulation, repetitive transcranial magnetic stimulation, and transcutaneous electrical nerve stimulation are extensively published although proper RCT-based evidence is limited. The European Headache Federation herewith provides a consensus statement on the clinical use of neuromodulation in headache, based on theoretical background, clinical data, and side effect of each method. This international consensus further gives recommendations for future studies on these new approaches.In spite of a growing field of stimulation devices in headaches treatment, further controlled studies to validate, strengthen and disseminate the use of neurostimulation are clearly warranted. Consequently, until these data are available any neurostimulation device should only be used in patients with medically intractable syndromes from tertiary headache centers either as part of a valid study or have shown to be effective in such controlled studies with an acceptable side effect profile.
Highlights
Headache is a common disease, its more severe manifestations such as intractable migraine and trigeminal autonomic cephalalgias have a debilitating effect on patients resulting in chronic pain and severe functional impairment
The medical treatment of patients with chronic primary headache syndromes is challenging as valid studies are few and in many cases even higher doses of preventative medication is ineffective and adverse side effects frequently complicate the course of medical treatment
The vast majority of these patients suffer from medication overuse headache which can and should be alleviated by detoxification, but a subset remains as refractory chronic migraine (RCM) [6]
Summary
Headache is a common disease, its more severe manifestations such as intractable migraine and trigeminal autonomic cephalalgias have a debilitating effect on patients resulting in chronic pain and severe functional impairment. Some patients may be intractable to the therapies recommended by national guidelines, and following the need of clinicians the word “intractable” has been defined by Goadsby et al entitled “Towards a Definition of Intractable Headache for Use in Clinical Practice and Trials” [10] In these patients, i.e. when the intolerance or lack of responsiveness to conservative treatments is ascertained, surgical options are considered. Technical progress has recently introduced the opportunity to use neurostimulation rather than ablative or destructive methods and it may be applied to virtually any neural structure, including spinal cord, deep brain structures, motor cortex and peripheral nerves It is not known how electrical stimulation of central or peripheral target structures exerts its effects, a neuronal functional block seems the most likely option
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