ABSTRACT
This chapter discusses the one ongoing multicenter, randomized, placebo-controlled trial of deep brain stimulation addressed the issues. The planning for a prospective, randomized, multicenter trial of anterior nucleus thalamus stimulation for epilepsy serves as an illustration of the issues to be considered in the design of brain stimulation protocols. The study patient care team and the team counting and interpreting outcome measures should not be aware of the treatment group. Theoretical problems with post-operative magnetic resonance image (MRI) include: To minimize chances of a complication from MRI, and to obtain approval of the Food and Drug Administration (FDA) to perform MRIs, the study sites agreed to adhere to the following protocol: The FDA and Medtronic warn against use of short-wave or ultrasound diathermy with stimulators in place. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned 'on' or 'off.
