Outcome Measures Following DBS Therapy Sample Clauses

Outcome Measures Following DBS Therapy. Clinical outcomes and complications associated with conventional surgical practices for DBS implantation, are evaluated by a movement disorder neurologist prior to DBS therapy and followed for prolonged periods post-operatively. [***] [***] Indicates portions of this exhibit that have been omitted and filed separately with the Securities and Exchange Commission pursuant to a request for confidential treatment. This study revealed a mean off medication UPDRS-III improvement of 52% with DBS, with a 95% confidence interval of 48-57%. For dystonia, optimal lead placement produced >50% decrease in the BFMDRS score (16). In terms of complications, asymptomatic hemorrhage was seen in 15 of 637 DBS implantations performed at our site between 1998-2006 (23). This rate of 2.4% is comparable to that previously reported (24) using stereotactic localization supported by MER. Our complication assessment also found poor electrode positioning, revealed by post-operative imaging and requiring re-operation, in 11 of 637 implantations (1.7%). Other complications included infection (1.9%), hemorrhagic stroke (1.3%), post-operative seizures (0.6%) and major air embolus (0.5%). This data provides a relevant retrospective control population against which the outcomes achieved with direct MR guidance can be evaluated.
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