Parkinson's Disease Clinical Trial
Official title:
Evaluation of the Infinity Deep Brain Stimulation Electrode Screening Mode Tool
The objective of this clinical investigation is to characterize the clinical performance of Abbott's Clinician Programmer Electrode Screening Mode tool (InformityTM tool) in programming InfinityTM deep brain stimulation (DBS) systems for patients with Parkinson's disease (PD) or essential tremor (ET).
This is a prospective, non-randomized, single-arm, multi-center, post-market clinical investigation designed to evaluate Abbott's Informity tool for Infinity DBS systems. This clinical investigation will be conducted at up to 5 centers in the United States. Up to 40 patients were intended to enroll in the study. However the study was stopped after enrolling 8 subjects at 3 sites. Subjects participating in this clinical investigation will be followed for 6 months. The expected duration of enrollment is 6 months. The total duration of the clinical investigation is expected to be 18 months. The primary and secondary endpoints will be evaluated when all subjects have completed their 6 month follow-up visits ;
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