Usability of therapy controllers in elderly patients with deep brain stimulation

<p>Abstract</p> <p>Background</p> <p>Technical devices are becoming more prevalent in society and also in medical care. Older adults need more support to learn new technologies than younger subjects. So far, no research has been done on the usability of patient controllers in deep brain stimulation in an elderly population. The aim of the study was to investigate the factors influencing the performance of elderly DBS patients with respect to usability aspects of Medtronic Access therapy controllers.</p> <p>Methods</p> <p>Time, mistakes and frequency of use of the controller were compared in 41 elderly DBS patients who prior to the study had already owned a therapy controller for more than six years. One group (n = 20, mean age = 66.4 years) was watching an instructional video and then completed practical assignments on a model implantable pulse generator (IPG). The other group (n = 21, mean age = 65.9 years) completed the tasks without having seen the video before. Any errors that patients made were documented and also corrected so that all of them received hands-on training. After six months all patients were re-evaluated on the dummy IPG in order to compare the effects of hands-on alone vs. video-based training combined with hands-on.</p> <p>Results</p> <p>The group that had seen the video before significantly outperformed the control group at both assessments with respect to number of errors. Both groups performed faster after six months compared to baseline and tend to use the controller more often than at baseline.</p> <p>Conclusion</p> <p>Our results indicate that elderly DBS patients who have been using the controller for several years still have various difficulties in operating the device. However, we also showed that age-specific training may improve the performance in older adults. In general, the design of DBS patient controllers should focus on the specific needs of the end-users. But as changes to medical devices take a long time to be implemented, video instructions with age-specific content plus hands-on training may improve learning for older adults.</p

134 VANTAGE Trial:Three-Year Outcomes of a Prospective, Multicenter Trial Evaluating Deep Brain Stimulation With a New Multiple-Source, Constant-Current Rechargeable System in Parkinson Disease

International audienceINTRODUCTION: Deep brain stimulation (DBS) has been demonstrated to be effective for Parkinson disease (PD) symptom relief. We sought to characterize the benefit of subthalamic nucleus (STN) DBS for PD patients using a recently CE-marked multiple-source, constant-current system that permits a well-defined distribution of applied current. We report the 3-year results of the first clinical trial using multiple independent current control (MICC) DBS in the management of symptoms of PD. METHODS: VANTAGE is a monitored, prospective, multicenter, nonrandomized, open-label interventional trial sponsored by Boston Scientific Corporation. Forty subjects with idiopathic PD were implanted bilaterally with a DBS system (Vercise) targeting the STN and followed up to 3 years after lead placement. Motor improvement was evaluated using Unified Parkinson's Disease Rating Scale (UPDRS) III scores in stim ON/meds OFF in comparison with preoperative scores. Other assessments such as CAPSIT motor tests, Tremor Rating Scale, Dyskinesia Rating Scale, PDQ-39, SF-36, Schwab and England, and resource utilization were administered. Patient motor diaries were collected over 3 days. Adverse events were also recorded. RESULTS: This study will report the safety and effectiveness outcomes of VANTAGE subjects at 3 years postimplantation as compared with baseline. CONCLUSION: The VANTAGE trial is the first reported trial of a multiple-source, constant-current rechargeable system for use in the management of PD symptoms. Study outcomes will inform clinicians on the use of this system and its flexibility to manage the symptoms of idiopathic PD

Multiple-source current steering in subthalamic nucleus deep brain stimulation for Parkinson's disease (the VANTAGE study): a non-randomised, prospective, multicentre, open-label study

International audienceBackground High-frequency deep brain stimulation (DBS) with a single electrical source is effective for motor symptom relief in patients with Parkinson's disease. We postulated that a multiple-source, constant-current device that permits well defined distribution of current would lead to motor improvement in patients with Parkinson's disease. Methods We did a prospective, multicentre, non-randomised, open-label intervention study of an implantable DBS device (the VANTAGE study) at six specialist DBS centres at universities in six European countries. Patients were judged eligible if they were aged 21–75 years, had been diagnosed with bilateral idiopathic Parkinson's disease with motor symptoms for more than 5 years, had a Hoehn and Yahr score of 2 or greater, and had a Unified Parkinson's disease rating scale part III (UPDRS III) score in the medication-off state of more than 30, which improved by 33% or more after a levodopa challenge. Participants underwent bilateral implantation in the subthalamic nucleus of a multiple-source, constant-current, eight-contact, rechargeable DBS system, and were assessed 12, 26, and 52 weeks after implantation. The primary endpoint was the mean change in UPDRS III scores (assessed by site investigators who were aware of the treatment assignment) from baseline (medication-off state) to 26 weeks after first lead implantation (stimulation-on, medication-off state). This study is registered with ClinicalTrials.gov, number NCT01221948. Findings Of 53 patients enrolled in the study, 40 received a bilateral implant in the subthalamic nucleus and their data contributed to the primary endpoint analysis. Improvement was noted in the UPDRS III motor score 6 months after first lead implantation (mean 13·5 [SD 6·8], 95% CI 11·3–15·7) compared with baseline (37·4 [8·9], 34·5–40·2), with a mean difference of 23·8 (SD 10·6; 95% CI 20·3–27·3; p&lt;0·0001). One patient died of pneumonia 24 weeks after implantation, which was judged to be unrelated to the procedure. 125 adverse events were reported, the most frequent of which were dystonia, speech disorder, and apathy. 18 serious adverse events were recorded, three of which were attributed to the device or procedure (one case each of infection, migration, and respiratory depression). All serious adverse events resolved without residual effects and stimulation remained on during the study. Interpretation The multiple-source, constant-current, eight-contact DBS system suppressed motor symptoms effectively in patients with Parkinson's disease, with an acceptable safety profile. Future trials are needed to investigate systematically the potential benefits of this system on postoperative outcome and its side-effects. Funding Boston Scientific