ABSTRACT
BACKGROUND: Subthalamic stimulation reduces motor disability and improves quality of life in patients with advanced Parkinson's disease who have severe levodopa-induced motor complications. We hypothesized that neurostimulation would be beneficial at an earlier stage of Parkinson's disease. METHODS: In this 2-year trial, we randomly assigned 251 patients with Parkinson's disease and early motor complications (mean age, 52 years; mean duration of disease, 7.5 years) to undergo neurostimulation plus medical therapy or medical therapy alone. The primary end point was quality of life, as assessed with the use of the Parkinson's Disease Questionnaire (PDQ-39) summary index (with scores ranging from 0 to 100 and higher scores indicating worse function). Major secondary outcomes included parkinsonian motor disability, activities of daily living, levodopa-induced motor complications (as assessed with the use of the Unified Parkinson's Disease Rating Scale, parts III, II, and IV, respectively), and time with good mobility and no dyskinesia. RESULTS: For the primary outcome of quality of life, the mean score for the neurostimulation group improved by 7.8 points, and that for the medical-therapy group worsened by 0.2 points (between-group difference in mean change from baseline to 2 years, 8.0 points; P=0.002). Neurostimulation was superior to medical therapy with respect to motor disability (P<0.001), activities of daily living (P<0.001), levodopa-induced motor complications (P<0.001), and time with good mobility and no dyskinesia (P=0.01). Serious adverse events occurred in 54.8% of the patients in the neurostimulation group and in 44.1% of those in the medical-therapy group. Serious adverse events related to surgical implantation or the neurostimulation device occurred in 17.7% of patients. An expert panel confirmed that medical therapy was consistent with practice guidelines for 96.8% of the patients in the neurostimulation group and for 94.5% of those in the medical-therapy group. CONCLUSIONS: Subthalamic stimulation was superior to medical therapy in patients with Parkinson's disease and early motor complications. (Funded by the German Ministry of Research and others; EARLYSTIM ClinicalTrials.gov number, NCT00354133.).
Subject(s)
Electric Stimulation Therapy , Parkinson Disease/therapy , Quality of Life , Activities of Daily Living , Adult , Antiparkinson Agents/adverse effects , Antiparkinson Agents/therapeutic use , Combined Modality Therapy , Dopamine Agonists/adverse effects , Dopamine Agonists/therapeutic use , Dyskinesias/etiology , Electric Stimulation Therapy/adverse effects , Female , Humans , Implantable Neurostimulators/adverse effects , Intention to Treat Analysis , Male , Middle Aged , Parkinson Disease/drug therapy , Parkinson Disease/physiopathology , Subthalamic Nucleus , Surveys and Questionnaires , Treatment OutcomeABSTRACT
OBJECTIVE: Oropharyngeal dysphagia is frequent in chronic neurological disorders and increases mortality, mainly due to pulmonary complications. Our aim was to show that submental sensitive transcutaneous electrical stimulation (SSTES) applied during swallowing at home can improve swallowing function in patients with chronic neurological disorders. METHODS: Thirteen patients were recruited for the study (4 f, 68 ± 12 years). They all suffered from neurogenic oropharyngeal dysphagia. We first compared the swallowing of paste and liquid with and without SSTES. Thereafter, the patients were asked to perform SSTES at home with each meal. Swallowing was evaluated before and after six weeks of SSTES using the SWAL-QoL questionnaire. RESULTS: With the stimulator switch turned on, swallowing coordination improved, with a decrease in swallow reaction time for the liquid (P<0.05) and paste boluses (P<0.01). Aspiration scores also decreased significantly with the electrical stimulations (P<0.05), with no change in stasis. At-home compliance was excellent and most patients tolerated the electrical stimulations with no discomfort. A comparison of the SWAL-QoL questionnaires after 6 weeks revealed an improvement in the burden (P=0.001), fatigue (P<0.05), and pharyngeal symptom (P<0.001) scales. CONCLUSION: The present study demonstrated that SSTES is easy to use at home and improves oropharyngeal dysphagia quality of life.