A Randomized Trial of Deep-Brain Stimulation for Parkinson’s Disease.
Deuschl, G.,Schade-Brittinger C, Krack P, Volkmann J, Schafer H, Botzel K, Daniels C, Deutschlander A, Dillmann U, Eisner W, Gruber D, Hamel W, Herzog J, Hilker R, Klebe S, Kloss M, Koy J, Krause M, Kupsch A, Lorenz D, Lorenzl S, Mehdorn HM, Moringlane JR, Oertel W, Pinsker MO, Reichmann H, Reuss A, Schneider GH, Schnitzler A, Steude U, Sturm V, Timmermann L, Tronnier V, Trottenberg T, Wojtecki L, Wolf E, Poewe W, & Voges J (2006) A Randomized Trial of Deep-Brain Stimulation for Parkinson’s Disease. , 355, 9, 896-908
This study looked at treatment efficacy in patients with PD treated with deep brain stimulation and medications to those patients treated only with medication.
Who were the patients in the study and what were they asked to do?
There were 156 patients in this study between 2001 and 2004. Patients were carefully screened for appropriateness for surgical candidacy before being assigned to surgery or medication only treatment groups. The authors created 78 pairs to be treated so they could evaluate of the pair, which had a better response to their therapy. There were 78 patients that underwent bilateral DBS-STN and 78 patients that were treated with the best medication practices available at that center. The patient’s were not different demographically (age: around 60, Duration of levodopa treatment 13-13.8 years, 50 males in each group, and similar Hoehn and Yahr stages). Patient’s were asked to complete the PDQ-39 (Parkinson’s Disease Questionnaire), Schwab and England Scale (test of functioning), Mattis Dementia Rating Scale (test of cognitive functioning), Montgomery and Asberg Depression Rating Scale and the Brief Psychiatric Rating Scale (both for neuropsychiatric functioning), Medical Outcomes Study 36-item Short Form General Health Survey (SF-36; quality of life measure), and were evaluated by the neurologist on the Unified Parkinson’s Disease Rating Scale (UPDRS). Patients were also asked to keep a diary of their mobility throughout the study before and after treatment initiation.
Who were the researchers?
The research in this study was conducted at 10 academic centers in Germany and Austria
What did the researchers find?
The researchers found that those patients treated with neurostimulation had more improvement in motor symptoms, dyskinesias, general health status, quality of life, mobility, activities of daily living, emotional well-being, stigma, and bodily discomfort as compared to those only treated with medication. Activities of daily living slightly declined in the medication only group. There were no improvements or differences between the groups in terms of social support, cognition, depression, or communication. According to the diaries kept by the patients, the group treated with neurostimulation showed significant improvement in their objective rating of their immobility, time of mobility w/o dyskinesia, time spent sleeping, and decreased time of bothersome dyskinesia and mobility.
Were there any serious adverse effects of treatment?
There were a total of 13 severe adverse events recorded between the groups (10 neurostimulation and 3 medication only). Three patients died in the neurostimulation group (1 from a bleed in the brain during surgery, 1 from pneumonia, and 1 suicide). In the medication group 1 patient died in a motor vehicle accident while in a psychotic state. The other events resolved without complication. There were a total of 173 non-severe adverse events in 89 patients (39 stimulator and 50 medication) between the groups. Many of these events are known medical problems due to advanced Parkinson’s disease.
What were the author’s conclusions?
The authors concluded that their study is the first controlled clinical trial to focus on effects of treatment in regard to not only motor symptoms but also quality of life in patients with advanced PD under the age of 75. They found that those patients treated with DBS-STN had more improvement than those patients only treated with medication.
Why was this study important?
This study is important to evaluate the efficacy of DBS on difficulties with motor functioning as well quality of life in patients with PD. DBS is a treatment modality that has known risks but it is vital to have studies that document its efficacy and symptomatic benefits as compared to other treatment options so that patients and clinicians can make informed choices in regards to treating Parkinson’s disease.