title: Protecting human subjects in neurosurgical trials: the challenge of psychogenic dystonia.
abstract: The discomfort and suffering of medically refractory organic dystonia has lead to the pursuit of new potential treatment interventions, namely, pallidotomy and deep brain stimulation (DBS). The risks inherent in surgical procedures require a heightened awareness to the need for protecting the welfare of research subjects participating in surgical trials. To this end, excluding patients who are not appropriate candidates is a key part of the trial process. We argue that psychogenic dystonia, a condition that is both difficult to diagnose and difficult to treat, should be an exclusion criterion for DBS therapy, and neurosurgery in general. However, since there exists no definitive test for psychogenic dystonia, researchers must determine fair and just criteria for excluding patients whose dystonia is suspected to be primarily psychogenic.
authors.affiliation: Research Subject Advocate Program, Cleveland Clinic, General Clinical Research Center, OH 44195, USA. txbioethics@yahoo.com
authors.forename: Katrina A
authors.initials: KA
authors.lastname: Bramstedt
authors.forename: Paul J
authors.initials: PJ
authors.lastname: Ford
mesh_terms: D002986:Clinical Trials as Topic / Q000941:ethics* / Q000379:methods; D046690:Deep Brain Stimulation; D020821:Dystonic Disorders / Q000628:therapy*; D032984:Ethics, Research; D005917:Globus Pallidus / Q000601:surgery; D006801:Humans; D019635:Neurosurgical Procedures / Q000941:ethics; D036302:Therapeutic Human Experimentation / Q000941:ethics*