title: Evaluating devices for treating epilepsy.
abstract: OBJECTIVE
  Research into new implantable devices for treating epilepsy is expanding rapidly. Pilot studies suggest sufficient safety and potential efficacy to justify proceeding with larger scale clinical trials. Understanding the challenges presented by these trials, the testing and approval process for implantable devices, and how these differ from requirements for antiepileptic drugs (AEDs) is vital to evaluating when and where these new technologies will fit into the therapeutic armamentarium.
  
  
  METHODS
  Important lessons regarding the limitations of uncontrolled pilot studies, patient registries, and how the Food and Drug Administration (FDA) approval process can influence trials are drawn from the implantable device literature. Some discussion of the role of animal experiments is presented, both as justification for investigational device exemptions and their potential role in establishing safety. Clinical trial experience with the vagal nerve stimulator, the first device approved for the treatment of epilepsy, is also discussed.
  
  
  RESULTS
  New implantable devices hold great promise for medically refractory epilepsy patients who have no other therapeutic alternative. If effective, they may become a viable alternative to epilepsy surgery or multiple AED therapy in appropriate patients.
  
  
  CONCLUSIONS
  The proper evaluation, use, and acceptance of antiepileptic devices will ultimately depend on carefully executed clinical trials that take into account unique aspects of these devices, such as the requirement for surgery, electrode placement, and navigation through FDA-monitored testing and approval.
authors.affiliation: Department of Neurology, University of Pennsylvania, Philadelphia, Pennsylvania 19104, USA. littb@mail.med.upenn.edu
authors.forename: Brian
authors.initials: B
authors.lastname: Litt
mesh_terms: D000818:Animals; D002986:Clinical Trials as Topic; D018795:Device Approval; D004599:Electric Stimulation Therapy / Q000295:instrumentation*; D004567:Electrodes, Implanted; D004827:Epilepsy / Q000628:therapy*; D004867:Equipment Design; D006801:Humans