A Randomized Trial of Deep-Brain Stimulation for Parkinson's Disease

Abstract

BACKGROUND Neurostimulation of the subthalamic nucleus reduces levodopa-related motor complications in advanced Parkinson's disease. We compared this treatment plus medication with medical management. METHODS In this randomized-pairs trial, we enrolled 156 patients with advanced Parkinson's disease and severe motor symptoms. The primary end points were the changes from baseline to six months in the quality of life, as assessed by the Parkinson's Disease Questionnaire (PDQ-39), and the severity of symptoms without medication, according to the Unified Parkinson's Disease Rating Scale, part III (UPDRS-III). RESULTS Pairwise comparisons showed that neurostimulation, as compared with medication alone, caused greater improvements from baseline to six months in the PDQ-39 (50 of 78 pairs, P = 0.02) and the UPDRS-III (55 of 78, P<0.001), with mean improvements of 9.5 and 19.6 points, respectively. Neurostimulation resulted in improvements of 24 to 38 percent in the PDQ-39 subscales for mobility, activities of daily living, emotional well-being, stigma, and bodily discomfort. Serious adverse events were more common with neurostimulation than with medication alone (13 percent vs. 4 percent, P<0.04) and included a fatal intracerebral hemorrhage. The overall frequency of adverse events was higher in the medication group (64 percent vs. 50 percent, P = 0.08). CONCLUSIONS In this six-month study of patients under 75 years of age with severe motor complications of Parkinson's disease, neurostimulation of the subthalamic nucleus was more effective than medical management alone.

Negative impact of borderline global cognitive scores on quality of life after subthalamic nucleus stimulation in Parkinson's disease

“…The original study included 156 patients [1,8]. In a randomised pair-design 78 patients were randomised into the STN-DBS group to receive DBS surgery within 6 weeks after enrolment and 78 patients were randomised receiving best medical treatment for 6 months according to German guidelines.…”

“…The study protocol was approved by the ethics committee at each participating centre, and all patients gave written informed consent. The study protocol and the peri-and postoperative procedures have been reported in detail elsewhere [1,8]. All clinical assessments (except the UPDRS III 'off' assessment and the levodopachallenge test) were performed under medication 'on' at baseline and at 6 months with neurostimulation 'on' and medication 'on.…”

“…The beneficial effect of bilateral deep brain stimulation (DBS) of the subthalamic nucleus (STN) on motor symptoms and on quality of life (QoL) in advanced Parkinson's disease (PD) has been shown by randomised controlled studies [1,2]. In consensus statements it is argued that dementia should be considered as a contraindication for surgery [3,4].…”

Deep brain stimulation in Parkinson disease—what went wrong?

“…Different surgical targets exist for different parkinsonian signs (Table 2) [30,31]. For the purpose of this review, we focus on the STN, which has become the main target, and DBS as the main surgical technique to improve motor symptoms and quality of life in PD [32,33]. In STN DBS for PD, the stimulating electrodes are aimed at the sensorimotor area of the STN to improve akinesia, rigidity and tremor.…”

Programmable Hypertension Control: Another Possible Indication for Implanted Pacemakers

“…This has generated great interest in tackling this significant clinical problem by addressing a root of the problem, sympathetic over‐activity leading to increased peripheral vascular resistance 4. Over the past decade, many investigators have enthusiastically worked at developing devices that could modulate the sympathetic nervous system in order to decrease blood pressure, attempting to replicate the success that device‐based therapies have had in other areas such as cardiac resynchronization therapy in patients with heart failure with reduced ejection fraction5 or deep brain stimulation for Parkinson's disease 6…”