This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator.We propose a pilot study designed to provide the necessary preliminary data to support a subsequent full-scale clinical trial that will test the hypothesis that chronic high frequency deep brain stimulation (DBS) of the bilateral subthalamic nuclei (B-STN) is a safe and effective treatment to slow the progression of PD.
Specific Aim #1 : To compare the safety and tolerability of B-STN DBS and optimal drug therapy (ODT) to ODT alone in early Parkinson's disease.
Specific Aim #2 : To determine the minimum length of time a subject must remain off medication and stimulation (washout period) to measure the fully untreated parkinsonian state ('OFF' condition).
Specific Aim #3 : To demonstrate that it is possible to recruit, provide meaningful informed consent, and retain subjects with early PD in a long-term clinical trial of B-STN DBS for the treatment of early PD.
Specific Aim #4 : To provide the data necessary to estimate sample size for a subsequent full-scale clinical trial of safety and efficacy.
Specific Aim #5 : To test the data management procedures for a subsequent full-scale clinical trial of safety and efficacy.
Specific Aim #6 : To test specific safety and patient outcome measures to inform data collection for a subsequent full-scale trial of safety and efficacy.
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