Neurotherapeutics

, Volume 4, Issue 3, pp 531–536 | Cite as

Placebo-controlled procedural trials for neurological conditions

Summary

Neurological disease has been a central focus in the ongoing ethical debate over the use of invasive placebo controls, especially sham surgery. The risk to research subjects and necessary use of deception involved in these procedures must be balanced against the methodological need to control for bias and the placebo effect. We review a framework formulated for the ethical assessment of sham surgery in the context of research evaluating novel procedures for neurological conditions. Special issues raised include the growing evidence of expectation and conditioning effects in a number of neurological diseases, the escalating scale of risk from different types of invasive placebo interventions, and the increasing use of cross-over designs, which allow a switch from placebo to active intervention without additional procedures.

Key Words

Placebo-controlled trials sham surgery cross-over ethics neurological procedures deception 

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Copyright information

© Springer New York 2007

Authors and Affiliations

  1. 1.Department of Brain and Cognitive SciencesMassachusetts Institute of TechnologyCambridge
  2. 2.Department of Clinical BioethicsNational Institutes of HealthBethesda

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