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

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Neuromodulation in Headache and Facial Pain Management

Part of the book series: Headache ((HEAD))

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Abstract

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].

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Author information

Authors and Affiliations

  1. Department of Clinical Physiology and Nuclear Medicine, Center for Functional and Diagnostic Imaging, Hvidovre Hospital, Copenhagen, Denmark

    Mads Barloese

  2. Danish Headache Center, Department of Neurology, Rigshospitalet-Glostrup, University of Copenhagen, Copenhagen, Denmark

    Mads Barloese

  3. Headache Centre, Guy’s and St Thomas’ NHS Foundation Trust, Pain Management and Neuromodulation Centre and Neurology Department, London, UK

    Giorgio Lambru

  4. Wolfson CARD, King’s College London, London, UK

    Giorgio Lambru

Authors
  1. Mads Barloese
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  2. Giorgio Lambru
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Correspondence to Mads Barloese .

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Editors and Affiliations

  1. Headache Centre, Guy’s and St Thomas’, NHS Foundation Trust, Pain Management and Neuromodulation Centre and Neurology Department, London, UK

    Giorgio Lambru

  2. Department de Traitement de la douleur, Centre Hospitalier Universitaire de Nice, Department de Traitement de la douleur, Nice, France

    Michel Lanteri-Minet

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Barloese, M., Lambru, G. (2020). Methodological Difficulties in Clinical Trials Assessing Neuromodulation Devices in the Headache Field. In: Lambru, G., Lanteri-Minet, M. (eds) Neuromodulation in Headache and Facial Pain Management. Headache. Springer, Cham. https://doi.org/10.1007/978-3-030-14121-9_17

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  • DOI: https://doi.org/10.1007/978-3-030-14121-9_17

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