Placebo Control and Patient Blinding in Clinical Trials of Neurostimulation Devices
*Nitzan Mekel-Bobrov, Boston Scientific Neuromodulation 

Keywords: placebo, blinding, neurostimulation

Placebo-controlled randomized controlled trials (RCTs) have become the gold standard in clinical research and are generally considered the superior form of evidence by which to assess the efficacy of an intervention. The use of placebo controls in medical device trials is often complicated by an added layer of complexity surrounding both ethical and logistical considerations. Of particular concern is maintenance of the double-blind. This is nowhere truer than neurostimulation clinical trials, given the active nature of these devices. In this talk, we will discuss the unique challenges encountered in designing clinical sham-controlled RCTs for deep brain stimulation (DBS). The discussion will focus on a case-study of DBS for the treatment of Parkinson’s disease and the logistical and analytical challenges encountered in accounting for proper maintenance and assessment of patient blinding.