Estimulacion Profunda En Enfemerdad De Parkinson

PALLIDAL VERSUS SUBTHALAMIC DEEP-BRAIN STIMULATION FOR PARKINSON'S DISEASE

Kenneth A. Follett, M.D., Ph.D., Frances M. Weaver, Ph.D., Matthew Stern, M.D., Kwan Hur, Ph.D., Crystal L. Harris, Pharm.D., Ping Luo, Ph.D., William J. Marks, Jr., M.D., Johannes Rothlind, Ph.D., Oren Sagher, M.D., Claudia Moy, Ph.D., Rajesh Pahwa, M.D., Kim Burchiel, M.D., Penelope Hogarth, M.D., Eugene C. Lai, M.D.,Ph.D., John E. Duda, M.D., Kathryn Holloway, M.D., Ali Samii, M.D., Stacy Horn, D.O., Jeff M. Bronstein, M.D., Ph.D., Gatana Stoner, R.N., C.C.R.C., Philip A. Starr, M.D., Ph.D., Richard Simpson, M.D., Ph.D., Gordon Baltuch, M.D., Ph.D., Antonio De Salles, M.D., Ph.D., Grant D. Huang, Ph.D., and Domenic J. Reda, Ph.D. for the CSP 468 Study Group
N Engl J Med 2010; 362:2077-2091June 3, 2010Background
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

Study Design
The details regarding study-site selection, the recruitment and assessment of patients, surgical interventions, and follow-up have been described previously.1 In brief, 316 patients were enrolled at seven Veterans Affairs and six affiliated university medical centers. Patients with idiopathic Parkinson's disease who were at least 21 years of age were eligible if they haddisease that was assessed as stage 2 or higher on the basis of the Hoehn and Yahr disability scale (on which scores range from 0 to 5, with higher scores indicating greater disability) while not receiving antiparkinsonian medication,3 had a response to levodopa, had persistent and disabling symptoms (e.g., motor fluctuations and dyskinesia) despite optimal medical therapy, had at least 3 hoursper 24-hour period with poor motor function or symptom control, and had been receiving medical therapy with no changes in the regimen for at least 1 month.
The first 255 patients participated in a 6-month comparison of medical therapy and deep-brain stimulation in which patients were randomly assigned to receive medical therapy or to undergo deep-brain stimulation (randomized to either pallidal orsubthalamic stimulation). After completing 6 months of medical therapy, patients proceeded to deep-brain stimulation, with random assignment to either pallidal or subthalamic stimulation. An interim analysis indicated that a sample of 255 patients was sufficient for the comparison between medical therapy and deep-brain stimulation, so the remaining 61 patients were randomly assigned directly toundergo pallidal or subthalamic stimulation.
Strict adherence to inclusion and exclusion criteria was maintained throughout the study. All patients who were assigned to undergo pallidal or subthalamic stimulation were followed for 24 months after surgery. Randomization was stratified according to study site and the patient's age (<70 vs. ≥70 years). Patients underwent surgery within 1 monthafter randomization and remained unaware of the surgical target for the duration of the study.
Evaluation
We evaluated patients after a 12-hour overnight withdrawal of antiparkinsonian medication. The stimulator was then turned off, and the patient was evaluated 60 minutes later (“without medication and without stimulation”). Finally, the stimulator was turned back on, and the patient took the usualdose of medication and was evaluated after 60 minutes (“with medication and with stimulation”).
At baseline, we evaluated motor symptoms in the absence of medication (in the “practically defined off state”), using part III (motor subscale) of the Unified Parkinson's Disease Rating Scale (UPDRS-III, on which scores range from 0 to 108 and higher scores indicate more severe motor symptoms) and...