Recruitment and Retention in Clinical Trials of Deep Brain Stimulation in Early-Stage Parkinson’s Disease: Past Experiences and Future Considerations

2018 ◽  
Vol 8 (3) ◽  
pp. 421-428 ◽  
Author(s):  
K. Grace Cannard ◽  
Mallory L. Hacker ◽  
Anna Molinari ◽  
Lauren E. Heusinkveld ◽  
Amanda D. Currie ◽  
...  
2021 ◽  
Vol 19 ◽  
Author(s):  
Yu Jin Jung ◽  
Han-Joon Kim ◽  
Sun Ha Paek ◽  
Beomseok Jeon

: Sleep-wake disturbances (SWD) are one of the most common non-motor symptoms in Parkinson's disease (PD) and can appear in the early stage even before the onset of motor symptoms. Deep brain stimulation (DBS) is an established treatment for the motor symptoms in patients with advanced PD. However, the effect of DBS on SWD and its specific mechanisms are not widely understood and remain controversial. In addition to the circuit-mediated direct effect, DBS may improve SWD by an indirect effect such as the resolution of nocturnal motor complications and a reduction of dopaminergic medication. Here, the authors review the recent literatures regarding the impact of DBS on SWD in patients with PD. Furthermore, the selection of the DBS targets and the specific effects of applying DBS to each target on SWD in PD are also discussed.


2015 ◽  
Vol 5 (1) ◽  
pp. 151-163 ◽  
Author(s):  
Michael G. Tramontana ◽  
Anna L. Molinari ◽  
Peter E. Konrad ◽  
Thomas L. Davis ◽  
Scott A. Wylie ◽  
...  

2014 ◽  
Vol 20 (7) ◽  
pp. 731-737 ◽  
Author(s):  
David Charles ◽  
Peter E. Konrad ◽  
Joseph S. Neimat ◽  
Anna L. Molinari ◽  
Michael G. Tramontana ◽  
...  

2017 ◽  
Vol 7 (1) ◽  
pp. 89-94 ◽  
Author(s):  
Lauren Heusinkveld ◽  
Mallory Hacker ◽  
Maxim Turchan ◽  
Madelyn Bollig ◽  
Christina Tamargo ◽  
...  

2021 ◽  
Vol 05 (02) ◽  
pp. 1-1
Author(s):  
Francesco Sciancalepore ◽  
◽  
Giulia Remoli ◽  
Leonardo Tariciotti ◽  
Giulia Sarti ◽  
...  

Deep-Brain Stimulation (DBS) is an important treatment option for the management of Parkinson’s disease (PD) and is a common symptomatic treatment. However, an increasing number of studies have examined the biological processes to assess if DBS can also modify the natural history of PD by acting on its pathophysiological mechanisms. Relevant literature published up to November 2020 was systematically searched on databases such as PubMed, ISI Web of Knowledge, Academic Search Index, and Science Citation Index. The following predefined inclusion criteria were applied to the full-text versions of the selected articles: i) recruiting and monitoring of PD subjects that were previously treated with DBS and ii) investigating the electrophysiological, biochemical, epigenetic, or neuroimaging effects of DBS. Studies focusing exclusively on motor and clinical changes were excluded. Reviews, case reports, studies on animal models, and computational studies were also not considered. Out of 2,960 records screened, 43 studies met the inclusion criteria. Only three studies described a potential disease-modifying effect of DBS. However, a wide heterogeneity was observed in the investigated biomarkers, and the design and methodological issues of several studies limited their ability to find potential disease-modifying features. Specifically, 60.4% of the trials followed-up subjects for no more than 1 year from the surgical intervention, and 67.4% observed patients with PD only once after DBS. Moreover, 64.2% of the studies enrolled late-stage PD patients. Most of the studies (88.4%) reported that DBS only had a symptomatic effect, with several of them showing some limitations in the study design and recruitment of patients. Further studies using shared biomarkers are encouraged to assess if and how DBS might affect the progression of PD. Based on the existing preclinical literature, prospective clinical trials examining the course of PD in early-stage patients are needed.


2011 ◽  
Vol 14 (6) ◽  
pp. 515-522 ◽  
Author(s):  
Chandler E. Gill ◽  
Laura A. Allen ◽  
Peter E. Konrad ◽  
Thomas L. Davis ◽  
Mark J. Bliton ◽  
...  

2021 ◽  
Vol 15 ◽  
Author(s):  
Shuo Xu ◽  
Wenfei Wang ◽  
Si Chen ◽  
Qianqian Wu ◽  
Chao Li ◽  
...  

BackgroundAs a complication-prone operation, deep brain stimulation (DBS) has become the first-line surgical approach for patients with advanced Parkinson’s disease (PD). This study aimed to evaluate the incidence and risk factors of DBS-associated complications.MethodsWe have reviewed a consecutive series of patients with PD undergoing DBS procedures to describe the type, severity, management, and outcome of postoperative complications from January 2011 to December 2018. Both univariate and multivariate analyses were performed to identify statistically significant risk factors. We also described our surgical strategies to minimize the adverse events.ResultsA total of 225 patients underwent 229 DBS implantation procedures (440 electrodes), of whom 20 patients experienced 23 DBS-associated complications, including ten operation-related complications and 13 hardware-related ones. Univariate analysis elucidated that comorbid medical conditions (P = 0.024), hypertension (P = 0.003), early-stage operation (P < 0.001), and unilateral electrode implantation (P = 0.029) as risk factors for overall complications, or more specifically, operation-related complications demonstrated in the stratified analysis. In contrast, no risk factor for hardware-related complications was identified. Statistical significances of hypertension (OR = 3.33, 95% CI: 1.14–9.71, P = 0.027) and early-stage (OR = 11.04, 95% CI: 2.42–50.45, P = 0.002) were further validated via multivariate analysis. As the annual number of DBS procedures increased, the incidence of complications gradually decreased (R = −0.699, P < 0.01). Additionally, there was a strong correlation between surgical complications and unplanned readmission (R = 0.730, P < 0.01).ConclusionThe importance of cumulative experience and relevant technique modifications should be addressed to prevent DBS-associated complications and unplanned readmission.


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