The overall goal of this project is to advance the proper clinical study and use of emerging neurosurgical technologies to alter brain function, such as DBS for PD. This goal requires attention to several essential conditions: appropriate incentives for clinicians in the neurosciences to conduct well-designed studies of neurosurgical technologies; patient trust in clinical research and the alteration of brain function as well as satisfaction with the respect and protection shown them as participants in neurological studies, and a national strategy of public and private support for the clinical study and use of emerging technologies, such as DBS.
Aim 1 is to recommend guidelines and mechanisms to direct the effective and ethical conduct of neurosurgical research involving DBS in persons with PD.
Aim 2 is to resolve the ethical and policy issue of public and private payer responsibility to cover emerging technologies such as DBS, including coverage for clinical trials. The guidelines, mechanisms, and policy recommendations generated will be informed by the analysis of data and insights gathered through questionnaires focusing on the DBS research experience of PD patients, family members, and researchers; coverage role-playing exercises with health system stakeholders; multidisciplinary working groups; a Minnesota Public-Private Partnership convened by the Minnesota Commissioner of Health; and the review of the project's conclusions and recommendations by a select national multidisciplinary panel from the fields of clinical research and health policy. Project outcomes will consist of eight papers for publication in peer-reviewed journals concerning the proper clinical study, use, and coverage of DBS for PD including educational tools on coverage decisions for emerging interventions (Aim 3). In addition, a national conference will conclude the project - diss3eminating the project's ethical and policy findings, tools, and recommendations in a forum intended to influence the regulatory and policy environment (Aim 4).
| Prehn, A W; Vawter, D E; Gervais, K G et al. (2006) Studying neurosurgical implants for Parkinson disease: a question of design. Neurology 67:1503-5 |
