The Design of Clinical Studies for Neuromodulation

  • Wael F. AsaadEmail author
  • Peter M. Lauro
  • Shane Lee


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.


Neuromodulation Deep brain stimulation Neurostimulation Lesion Focused ultrasound Clinical trials Trial design 


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Copyright information

© Springer Nature Switzerland AG 2020

Authors and Affiliations

  1. 1.Neurosurgery, Neuroscience, and the Carney Institute for Brain ScienceBrown University Alpert Medical School and the Norman Prince Neurosciences Institute of Rhode Island HospitalProvidenceUSA
  2. 2.Department of Neuroscience, Warren Alpert Medical SchoolBrown UniversityProvidenceUSA
  3. 3.Neurosurgery, Neuroscience, and the Carney Institute for Brain ScienceBrown University and the Norman Prince Neurosciences Institute of Rhode Island HospitalProvidenceUSA

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