Methodological Difficulties in Clinical Trials Assessing Neuromodulation Devices in the Headache Field

  • Mads BarloeseEmail author
  • Giorgio Lambru
Part of the Headache book series (HEAD)


Neuromodulation constitutes an entirely new discipline within headache therapy and its development was motivated largely by the unmet needs of chronic headache patients. The early, invasive strategies were primarily reserved for difficult-to-treat patients with a high headache burden. Newer, minimally- and non-invasive approaches have partly unmasked the complexity of defining common indications for all forms of neurostimulation. As the number of options available to clinicians expands, the field is becoming increasingly fragmented, partly a consequence of the lack of guidelines for the design of trials of neuromodulation. Such guidelines exist for drug trials in migraine, cluster headache (CH) and tension-type headache [1–4]. Although there are similarities between conducting trials in drugs and neuromodulation, major differences are obvious. No clear consensus has been agreed on how clinical trials in neuromodulation should be conducted, and common reporting standards are lacking. There is considerable heterogeneity in the methodology applied in published trials which represents a significant obstacle in the attempt to compare outcomes [5].


Refractory headache Occipital nerve stimulation Deep brain stimulation Sphenopalatine ganglion stimulation Sham device 


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Copyright information

© Springer Nature Switzerland AG 2020

Authors and Affiliations

  1. 1.Department of Clinical Physiology and Nuclear MedicineCenter for Functional and Diagnostic Imaging, Hvidovre HospitalCopenhagenDenmark
  2. 2.Danish Headache Center, Department of Neurology, Rigshospitalet-Glostrup, University of CopenhagenCopenhagenDenmark
  3. 3.Headache Centre, Guy’s and St Thomas’ NHS Foundation TrustPain Management and Neuromodulation Centre and Neurology DepartmentLondonUK
  4. 4.Wolfson CARD, King’s College LondonLondonUK

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