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A comparison of best medical therapy and DBS for treatment of PD: baseline characteristics

Weaver FM, Follett K, Stern M, Hur K, Ippolito D, Rothlind J. A comparison of best medical therapy and DBS for treatment of PD: baseline characteristics. Poster session presented at: Movement Disorder Society International Annual Congress; 2005 Mar 1; New Orleans, LA.

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Abstract:

Objective: To compare effectiveness of STN and GPi DBS in attenuating PD symptoms at 2 yrs; and effectiveness of best medical therapy(BMT) to DBS in improving symptoms at 6 months.Background: Studies indicate that STN and GPi DBS ameliorate PD symptoms; however whether DBS is superior to BMT, benefit is maintained, or which DBS site is better is unknown.Methods: This study will enroll 316 patients at 16 sites(7 VA;9 university) over 3 yrs. Patients are randomized to BMT or immediate DBS. BMT subjects receive medical therapy for 6 months before surgery. All patients are randomized to STN or GPi DBS and followed 2-3 years. 6-month outcome is time on without troubling dyskinesias; 2-year outcome is UPDRS off meds/on stim. Secondary outcomes include UPDRS ADL, PDQ-39, SF-36, QWB, health resource use, complications, neuropsychological tests, and medication use.Results: 179 patients(102 VA;79 university) have been enrolled. Mean age is 62.9; mean time with PD is 12.3 years, 20% are women. Mean UPDRS baseline score off meds is 45.5. University and VA patients are similar on demographic and baseline clinical characteristics, with the exception of a lower female to male veteran ratio. Veterans scored lower on neuropsychological tests assessing auditory working memory, verbal associative fluency and learning, and visuomotor speed(ps < .03) despite matching on age and education. Differences may be attributable to gender differences in psychometric performance previously demonstrated in neurologically healthy adults. Auditory working memory and verbal learning scores were lower among males, even within the University sample(ps = .04;.009). However, male veterans performed lower than male University subjects on verbal learning/memory task and verbal associative fluency at baseline (ps < .03).Conclusions: Study participants are older(62 yrs) than reported in prior DBS studies(56 yrs), suggesting that findings may be more generalizable. Baseline demographic and clinical differences are small, but some differences in neuropsychological performance are noted between veterans and university subjects. Of interest is whether within and between groups variability in baseline characteristics(including neuropsychological functioning) relate to outcomes. Results expected in 2007.





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