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The Design of Clinical Studies for Neuromodulation

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Stereotactic and Functional Neurosurgery

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Abstract

Creating successful new neuromodulation therapies requires innovative trial design and the balancing of a wide variety of complex factors. The ultimate goal is to advance our ability to restore appropriate brain function through the targeted manipulation of neural circuits and, to this end, clinical trials should be just as informative in failure as they are in success. Some aspects of neuromodulation trials are common to all clinical studies, while other aspects are fairly specific to invasive neurosurgical interventions for complex neurological and psychiatric disease. This chapter examines the major factors to be considered in constructing clinical studies to investigate the various forms and applications of novel neuromodulation strategies.

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Authors and Affiliations

  1. Neurosurgery, Neuroscience, and the Carney Institute for Brain Science, Brown University Alpert Medical School and the Norman Prince Neurosciences Institute of Rhode Island Hospital, Providence, RI, USA

    Wael F. Asaad

  2. Department of Neuroscience, Warren Alpert Medical School, Brown University, Providence, RI, USA

    Peter M. Lauro

  3. Neurosurgery, Neuroscience, and the Carney Institute for Brain Science, Brown University and the Norman Prince Neurosciences Institute of Rhode Island Hospital, Providence, RI, USA

    Shane Lee

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  1. Wael F. Asaad
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  2. Peter M. Lauro
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  3. Shane Lee
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Correspondence to Wael F. Asaad .

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Editors and Affiliations

  1. Department of Neurosurgery, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA

    Nader Pouratian

  2. Department of Neurosurgery, Baylor College of Medicine, Houston, TX, USA

    Sameer A. Sheth

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Asaad, W.F., Lauro, P.M., Lee, S. (2020). The Design of Clinical Studies for Neuromodulation. In: Pouratian, N., Sheth, S. (eds) Stereotactic and Functional Neurosurgery. Springer, Cham. https://doi.org/10.1007/978-3-030-34906-6_37

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