468 Study - Phase 2 (Veterans Affairs Cooperative Studies Program (CSP) 468 study)
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Primary study

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Phase II Subthalamic Nucleus (STN) vs. Globus Pallidus (GPi) Trial

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Registry of Trials clinicaltrials.gov
Year 2002
Links Registry of Trials

This article is not included in any systematic review

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The goal of the second phase of the study is to determine if simultaneous bilateral subthalamic nucleus stimulation or simultaneous bilateral globus pallidus stimulation is more effective in reducing symptoms of Parkinson\'s Disease.

Primary study

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Pallidal versus subthalamic deep-brain stimulation for Parkinson's disease

Journal The New England journal of medicine
Year 2010
Links Pubmed DOI www.scopus.com

This article is included in 12 Systematic reviews Systematic reviews (12 references)

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Background: Deep-brain stimulation is the surgical procedure of choice for patients with advanced Parkinson's disease. The globus pallidus interna and the subthalamic nucleus are accepted targets for this procedure. We compared 24-month outcomes for patients who had undergone bilateral stimulation of the globus pallidus interna (pallidal stimulation) or subthalamic nucleus (subthalamic stimulation). Methods: At seven Veterans Affairs and six university hospitals, we randomly assigned 299 patients with idiopathic Parkinson's disease to undergo either pallidal stimulation (152 patients) or subthalamic stimulation (147 patients). The primary outcome was the change in motor function, as blindly assessed on the Unified Parkinson's Disease Rating Scale, part III (UPDRS-III), while patients were receiving stimulation but not receiving antiparkinsonian medication. Secondary outcomes included selfreported function, quality of life, neurocognitive function, and adverse events. Results: Mean changes in the primary outcome did not differ significantly between the two study groups (P = 0.50). There was also no significant difference in self-reported function. Patients undergoing subthalamic stimulation required a lower dose of dopaminergic agents than did those undergoing pallidal stimulation (P = 0.02). One component of processing speed (visuomotor) declined more after subthalamic stimulation than after pallidal stimulation (P = 0.03). The level of depression worsened after subthalamic stimulation and improved after pallidal stimulation (P = 0.02). Serious adverse events occurred in 51% of patients undergoing pallidal stimulation and in 56% of those undergoing subthalamic stimulation, with no significant between-group differences at 24 months. Conclusions: Patients with Parkinson's disease had similar improvement in motor function after either pallidal or subthalamic stimulation. Nonmotor factors may reasonably be included in the selection of surgical target for deep-brain stimulation. Copyright © 2010 Massachusetts Medical Society.

Primary study

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Randomized trial of deep brain stimulation for Parkinson disease: thirty-six-month outcomes.

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Journal Neurology
Year 2012
Links Pubmed DOI PubMed Central www.scopus.com

This article is included in 7 Systematic reviews Systematic reviews (7 references)

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<b>OBJECTIVES: </b>Our objective was to compare long-term outcomes of deep brain stimulation (DBS) of the globus pallidus interna (GPi) and subthalamic nucleus (STN) for patients with Parkinson disease (PD) in a multicenter randomized controlled trial.<b>METHODS: </b>Patients randomly assigned to GPi (n = 89) or STN DBS (n = 70) were followed for 36 months. The primary outcome was motor function on stimulation/off medication using the Unified Parkinson's Disease Rating Scale motor subscale. Secondary outcomes included quality of life and neurocognitive function.<b>RESULTS: </b>Motor function improved between baseline and 36 months for GPi (41.1 to 27.1; 95% confidence interval [CI] -16.4 to -10.8; p &lt; 0.001) and STN (42.5 to 29.7; 95% CI -15.8 to -9.4; p &lt; 0.001); improvements were similar between targets and stable over time (p = 0.59). Health-related quality of life improved at 6 months on all subscales (all p values significant), but improvement diminished over time. Mattis Dementia Rating Scale scores declined faster for STN than GPi patients (p = 0.01); other neurocognitive measures showed gradual decline overall.<b>CONCLUSIONS: </b>The beneficial effect of DBS on motor function was stable and comparable by target over 36 months. Slight declines in quality of life following initial gains and gradual decline in neurocognitive function likely reflect underlying disease progression and highlight the importance of nonmotor symptoms in determining quality of life.<b>Classification Of Evidence: </b>This study provides Class III evidence that improvement of motor symptoms of PD by DBS remains stable over 3 years and does not differ by surgical target. Neurology® 2012;79:55-65.