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Competing Interests: Declaration of competing interest Dr. Isaacson: Dr. Isaacson reports honoraria for CME, consultancy, research grants, and/or promotional speaker work on behalf of AbbVie, Acadia Pharmaceuticals, Acorda Therapeutics, Addex, Affiris, Alexza, Allevion, Amneal Pharmaceuticals, Annovis, Aptinyx, Athira, Bial, Biogen, BlueRock, Britannia Pharmaceuticals, Bukwang, Cala, Cerecor, Cerevel, CND, Eli Lilly, Enterin, Exeltis, Esteve, Fasikl, GE Healthcare, Global Kinetics, Inhibikase, Intra-Cellular Therapies, Ipsen, Jazz, Kyowa Kirin, Lundbeck, Medscape, Merz, Michael J. Fox Foundation, Mitsubishi Tanabe, Neuralys, Neurocrine, Neuroderm, Neurolive, Exeltis, Novartis, ONO Pharmaceutical, Parkinson Study Group, Pharma2B, Praxis, Revance, Roche, Sage, Sanofi, Scion, Stoparkinson, Sunovion Pharmaceuticals Inc, Sun Pharma, Supernus, Teva, Theravance, Transposon, UCB. Dr. Phillips: Dr. Phillips has no conflicts of interest to declare. Dr. Jimenez-Shahed: Dr. Jimenez-Shahed has received research grants from Annovis Bio, Sage Therapeutics, Amneal Pharmaceuticals, and The Michael J. Fox Foundation; consulting fees from Medtronic, AbbVie, AlphaOmega, Teva, Nuvelution, and Signant Health; service on data safety monitoring board for BlueRock Therapuetics and Emalex; advisory board for PhotoPharmics.

Introduction: Device-aided therapy may improve the quality of life (QoL) for people with advanced Parkinson's disease (PD) and poorly controlled symptoms with oral therapy. MANAGE-PD is a validated tool classifying patients based on symptom control and advanced treatment eligibility. This study focused on patient/caregiver reported outcomes and healthcare resource utilization among patients grouped by MANAGE-PD categories., Methods: Device-aided therapy-naïve patients receiving oral treatments were identified from the Adelphi Parkinson's Disease Programme. Patients were categorized (category 1 to 3) using MANAGE-PD. PD-specific QoL (PDQ-39), care partner burden (ZBI), satisfaction with current treatment, healthcare resource utilization, associated healthcare costs, and future treatment discussion with providers were measured. Categories were compared using ANOVA, t-test, chi square and adjusted regression analyses., Results: Of the analytical sample (n = 2709), 18.9% were inadequately controlled on current therapy and potentially eligible for device-aided therapies (category 3). As expected, they had worse patient/caregiver reported outcomes versus patients in categories 1 or 2. However, the degree of difference in healthcare resource utilization, including: greater number of hospitalizations, emergency room (ER) visits and consultations, higher likelihood of being recipients of respite care, and greater PD treatment burden, was unexpected. Importantly, of patients in category 3 and their care partners, >40% did not report discussions with providers about device-aided therapies., Conclusion: MANAGE-PD category 3 patients had significantly higher burden on healthcare resources versus patients well-controlled with oral treatment or requiring only oral medication adjustments; yet almost half had no discussion on device-aided therapies with providers. Device-aided therapies may be considered in these patients., Competing Interests: Declaration of competing interest No conflict of interest., (Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Introduction: Deep brain stimulation (DBS) is an effective treatment for Parkinson's disease (PD), but its efficacy is tied to DBS programming, which is often time consuming and burdensome for patients, caregivers, and clinicians. Our aim is to test whether the Mobile Application for PD DBS (MAP DBS), a clinical decision support system, can improve programming., Methods: We conducted an open-label, 1:1 randomized, controlled, multicenter clinical trial comparing six months of SOC standard of care (SOC) to six months of MAP DBS-aided programming. We enrolled patients between 30 and 80 years old who received DBS to treat idiopathic PD at six expert centers across the United States. The primary outcome was time spent DBS programming and secondary outcomes measured changes in motor symptoms, caregiver strain and medication requirements., Results: We found a significant reduction in initial visit time (SOC: 43.8 ± 28.9 min n = 37, MAP DBS: 27.4 ± 13.0 min n = 35, p = 0.001). We did not find a significant difference in total programming time between the groups over the 6-month study duration. MAP DBS-aided patients experienced a significantly larger reduction in UPDRS III on-medication scores (-7.0 ± 7.9) compared to SOC (-2.7 ± 6.9, p = 0.01) at six months., Conclusion: MAP DBS was well tolerated and improves key aspects of DBS programming time and clinical efficacy., Competing Interests: Conflicts of interest There are potential conflicts of interested related to Medtronic, Boston Scientific, and Abbott, who are the device manufacturers who produced the DBS systems implanted in the study subjects. The University of Florida has received grants from Medtronic, Boston Scientific, and Abbott, but the authors have financial interest in these grants. ARZ serves as a consultant for Medtronic and Boston Scientific. IUH has performed research for Boston Scientific, and has consulted for Boston Scientific and Medtronic. JLO has received grant support from Boston Scientific and Medtronic, has consulted for Medtronic and Abbott, and received non-financial research support from Boston Scientific. MSS has received grant support from Boston Scientific, and honoraria/nonfinancial support as a scientific advisor from Boston Scientific. As the director of the Movement Disorders Fellowship at the University of Florida, CWH has received industry grants for educational support for the fellowship program that are paid directly to the University of Florida and used solely for fellow salary support from Medtronic, Boston Scientific, and Abbott. MHP has received consultation fees from Medtronic, Boston Scientific, and Abbot. MSL has received consulting fees from Boston Scientific. CRB has received consulting feeds from Boston Scientific and Abbott, and he holds intellectual property related to DBS. KDF has received occasional consulting fees from Medtronic and Boston Scientific for DBS related work. University of Florida has received implantable devices for KDF's DBS-related research, but not for this trial, from Medtronic. The University of Florida receives partial funding for KDF's functional neurosurgery fellowship from Medtronic. KDF holds three DBS related patents for which he has received no royalties. KDF has participated as a site implanting surgeon in multicenter DBS-related research studies sponsored by Abbott and Boston Scientific. MV has received consultation fees from Medtronic. PZ has received honorariums as a consultant and part of an advisory panel with Medtronic. JJS has received research support from Medtronic and Abbott, and has received consulting fees from Medtronic, Abbott, and, Boston Scientific. MSO, EM, BJL, CCA, SC, AT, GD, JLW, CG, AB, NN, DS, JC, MH, MA, and AS have nothing to disclose., (Copyright © 2023 Elsevier Ltd. All rights reserved.)

Introduction: Making Informed Decisions to Aid Timely Management of Parkinson's Disease (MANAGE-PD) is a clinician-reported tool designed to facilitate timely identification and management of patients with advancing Parkinson's disease (PD) with suboptimal symptom control while on standard therapy. The objective of this study was to evaluate the validity and clinical value of the tool., Methods: Driven by structured inputs from a steering committee and panel of PD experts, the tool was developed to classify patients into 3 categories. Validity and clinical value were elucidated using a two-pronged approach: (i) hypothetical patient vignettes (n = 10) developed based on the MANAGE-PD tool and rated by 17 PD specialists and 400 general neurologists (GN) and (ii) patients with PD (n = 2546) managed in real-world clinical settings. Vignette validity was based on concordance between PD experts' clinical judgement and MANAGE-PD vignette categorization. Patient-level data was used for known-group comparisons (validity) and discordant pair analysis (clinical value)., Results: The tool demonstrated strong validity and clinical value among PD specialists (intraclass coefficient [ICC] 0.843; Fleiss weighted kappa [ƙ weighted ] 0.79) and GN (ICC 0.690; ƙ weighted 0.65) using patient vignettes. MANAGE-PD also demonstrated real-world validity and clinical value based on ability to identify patients with incrementally higher clinical, economic, and humanistic PD burden across categories of the tool (p < 0.01)., Conclusions: MANAGE-PD demonstrated robust validity and clinical value in identifying patients with suboptimal PD symptom control. Clinical use of MANAGE-PD may complement treatment decision-making and facilitate timely and comprehensive management of patients with advancing PD., (Copyright © 2021 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Background: The initial COVID-19 pandemic shutdown led to the canceling of elective surgeries throughout most of the USA and Canada., Objective: This survey was carried out on behalf of the Parkinson Study Group (PSG) to understand the impact of the shutdown on deep brain stimulation (DBS) practices in North America., Methods: A survey was distributed through RedCap® to the members of the PSG Functional Neurosurgical Working Group. Only one member from each site was asked to respond to the survey. Responses were collected from May 15 to June 6, 2020., Results: Twenty-three sites participated; 19 (83%) sites were from the USA and 4 (17%) from Canada. Twenty-one sites were academic medical centers. COVID-19 associated DBS restrictions were in place from 4 to 16 weeks. One-third of sites halted preoperative evaluations, while two-thirds of the sites offered limited preoperative evaluations. Institutional policy was the main contributor for the reported practice changes, with 87% of the sites additionally reporting patient-driven surgical delays secondary to pandemic concerns. Pre-post DBS associated management changes affected preoperative assessments 96%; electrode placement 87%; new implantable pulse generator (IPG) placement 83%; IPG replacement 65%; immediate postoperative DBS programming 74%; and routine DBS programming 91%., Conclusion: The COVID-19 pandemic related shutdown resulted in DBS practice changes in almost all North American sites who responded to this large survey. Information learned could inform development of future contingency plans to reduce patient delays in care under similar circumstances., (Copyright © 2021 Elsevier Ltd. All rights reserved.)

Introduction: Deep brain stimulation (DBS) surgery is an efficacious, underutilized treatment for Parkinson's disease (PD). Studies of DBS post-operative outcomes are often restricted to data from a single center and consider DBS in isolation. National estimates of DBS readmission and post-operative outcomes are needed, as are comparisons to commonly performed surgeries., Methods: This study used datasets from the 2013 and 2014 Nationwide Readmissions Database (NRD). Our sample was restricted to PD patients discharged alive after hospitalization for DBS surgery. Descriptive analyses examined patient, clinical, hospital and index hospitalization characteristics. The all-cause, non-elective 30-day readmission rate after DBS was calculated, and logistic regression models were built to examine factors associated with readmission. Readmission rates for the most common surgical procedures were calculated and compared to DBS., Results: There were 6058 DBS surgeries for PD in our sample, most often involving a male aged 65 and older, who lived in a high socioeconomic status zip code. DBS patients had an average of four comorbidities. With respect to outcomes, the majority of patients were discharged home (95.3%). Non-elective readmission was rare (4.9%), and was associated with socioeconomic status, comorbidity burden, and teaching hospital status. Much higher acute, non-elective readmission rates were observed for common procedures such as upper gastrointestinal endoscopy (16.2%), colonoscopy (14.0%), and cardiac defibrillator and pacemaker procedures (11.1%)., Conclusion: Short-term hospitalization outcomes after DBS are generally favorable. Socioeconomic disparities in DBS use persist. Additional efforts may be needed to improve provider referrals for and patient access to DBS., Competing Interests: Declaration of competing interest RBS: Has no conflicts of interest relevant to this work but reports grant support from the National Institute of Neurological Disorders and Stroke, Biohaven Pharmaceuticals, CHDI Foundation, Teva Pharmaceuticals, Pfizer, Nuredis Inc., The Michael J. Fox Foundation, and the Canadian Institute of Health Research as well as financial support from the Parkinson's Foundation. JJ-S: Reports research support from Medtronic and St. Jude Medical/Abbott as well as consulting agreements with Medtronic, St. Jude Medical/Abbott, and Boston Scientific relevant to this work. Also reports research support from Teva and Lilly; consulting agreements with Bracket and Nuvelution; and grant support from the National Institute of Neurological Disorders and Stroke, the Michael J. Fox Foundation, and the Simons Foundation. DSA: Has no conflicts of interest relevant to this work but reports research support from the National Institutes of Health and financial support from the Parkinson's Foundation. DPT: None. SM: None. MF: Has no conflicts of interest relevant to this work but reports active research funding from the American Academy of Neurology, American Brain Foundation, and the Parkinson's Foundation. MAB: Has no conflicts of interest relevant to this work but reports active research funding from the Parkinson's Foundation. KLC: Has no conflicts of interest relevant to this work but reports active research funds from the National Institutes of Health and the Parkinson Study Group, consulting agreements with Sunovion Pharmaceuticals, and royalties from UpToDate and Springer. MS: Has no conflicts of interest relevant to this work but reports active research funding from Abbvie, USWorldMeds, Sanofi, Lundbeck, and Abbott. WJJ: None. P-FD: Has no conflicts of interest relevant to this work but reports service as an Officer of Neurotargeting LLC. MKY: Has no conflicts of interest relevant to this work but reports personal compensation for consultant, Steering Committee, and Data Safety Monitoring Board service from the Michael J. Fox Foundation and Boston Scientific. JCK: None. JMS: Has no conflicts of interest relevant to this work but reports research grants from Medtronic, service as a consultant for Guidant, LLC, and salary support from Blue Cross Blue Shield of Michigan. AJE: Has no conflicts of interest relevant to this work but reports grant support from the National Institutes of Health, Great Lakes Neurotechnologies, and the Michael J Fox Foundation; personal compensation as a consultant/scientific advisory board member for Abbvie, Neuroderm, TEVA, Impax, Acadia, Acorda, Cynapsus/Sunovion, Lundbeck, Osmotica Pharmaceutical, and USWorldMeds; publishing royalties from Lippincott Williams & Wilkins, Cambridge University Press, and Springer; and honoraria from Abbvie, UCB, USWorldMeds, Lundbeck, Acadia, the American Academy of Neurology, and the Movement Disorders Society. LCS: Has no conflicts of interest relevant to this work but reports employment with Biogen, Inc. DKS: Has no conflicts of interest relevant to this work but reports research funding from BioElectron Technology, Lysosomal Therapeutics, Mission Therapeutics, Voyager Therapeutics, the Weston Brain Institute, and the National Institutes of Health as well as honorarium for Steering Committee service from the Michael J. Fox Foundation and Biogen. CH: None. JAGC: Has no conflicts of interest relevant to this work but reports research support from the Northern Ontario Academic Medicine Association. AWW: Has no conflicts of interest relevant to this work but reports research funding from the National Institutes of Health and the Parkinson's Foundation., (Copyright © 2019. Published by Elsevier Ltd.)

Objective: The neuroanatomic substrate of restless legs syndrome (RLS) is unknown. Deep brain stimulation (DBS) of the globus pallidus internus (GPi) and other targets is used to treat Parkinson's disease (PD), and RLS symptoms associated with PD have been reported to improve when GPi DBS is used in that population. We wish to test whether GPi DBS can improve idiopathic RLS., Method: We implanted bilateral GPi DBS in a subject with refractory idiopathic RLS., Results: The GPi cells recordings were dissimilar to those of PD. Clinically, the patient had a good, but far from complete, response, which more prominently affected the urge to move and involuntary movements than the painful component., Conclusion: DBS for RLS remains investigational., (Copyright © 2012. Published by Elsevier B.V.)