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From : WE MOVE Early DBS Surgery is Superior to Best Medical Management 02/28/2007 Neurosurgery at an earlier stage of Parkinson disease: A randomized, controlled trial WMM Schupbach, D Maltete, JL Houeto, S Tezenas de Montcel, L Mallet, ML Welter, M Garguilo, C Behar, AM Bonnet, V Czernecki, B Pidoux, S Navarro, D Dormont, P Cornu, Y Agid Neurology 2007;68:267-271 ---------------------------------------------------------------------- Summary: "Patients with mild-to-moderate PD who receive DBS surgery have a better quality of life 18 months after surgery than patients receiving best medical management, according to this study. Twenty PD patients with mild-to-moderate disease were enrolled. Patients were younger than age 55; had a disease duration of between 5 and 10 years; had Hoehn and Yahr scores less than or equal to 3; experienced motor fluctuations and off periods more than 25% of the waking day; and were employed. After entry, patients were pair- matched for age, disease duration, and UPDRS scores, and then randomized to receive STN DBS surgery or best medical management. Evaluations occurred at 6, 12, and 18 months post-surgery. The primary endpoint was change in overall quality of life as determined by the PDQ-39. At 18 months, surgically treated patients had a 24% improved QoL, versus no change for medically treated patients. The surgically treated group did better on activities of daily living, stigmatization, and bodily discomfort subdomains of the scale. ADLs off medication also improved significantly in surgically treated patients, while those receiving medical management worsened. ADLs on medication did not differ between the groups. Motor scores off and on medication showed a similar pattern. Levodopa use decreased by 57% and motor complications improved by 83% in surgically treated patients, versus a 12% increase in levodopa and 15% motor complication worsening for medically treated patients. Neuropsychological complications of surgery included transient depression (n=4, versus 3 in medically managed patients), transient hypomania (n=5), somatoform disorder (n=1). Anxiety and psychiatric morbidity improved as a whole for the surgically treated group. The authors conclude, "Neurosurgery may thus be considered superior to medical management alone even in mild to moderate PD of < 10 years' duration, rather than as a last resort in very advanced stages of the disease. However, the advantages of STN stimulation must be weighed carefully against the risk with death or sequelae of cerebral hemorrhage reported in 0 to 5% of patients undergoing surgery." In an accompanying editorial, David Riley and Andres Lozano write, "There is a trend toward early DBS in PD management, and this trial offers the best support of that trend to date..[U]ltimately the results indicate that earlier application of DBS represents an improvement over our current approach to management of PD." NOTE: From the full text article, 2 important points not included in this summary: "The study was supported by Medtronic Europe." (Medtronic produces the stimulators that are used for DBS) "Disclosure: Medtronic sponsored the study and provided the stimulators. However, Medtronic had no influence on decisions concerning the study design; on the enrollment of patients; on the collection, analysis, and interpretation of data; on the writing of the report; and on the decision to submit the paper for publication." " The study design was open label because sham surgery was considered unacceptable by our Ethics Committee. Thus, a placebo effect of surgery cannot be excluded, but it is unlikely to persist to a relevant degree after 18 months. The size of our study was relatively small, but patients were very carefully selected and matched before randomization. " ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn