@article{f6e72cfd01fc46c8a1a9c922bbc52ed3,
title = "Necessity and feasibility of remote tele-programming of deep brain stimulation systems in Parkinson's disease",
abstract = "Introduction: Outcomes after deep brain stimulation (DBS) therapy are dependent on good surgical placement in the target nucleus and optimized stimulation parameters through multiple programming sessions. This often requires frequent travel to a specialized DBS center, which presents a challenge for those with limited access. Recently, the FDA approved a remote tele-programming solution for DBS. To determine if remote tele-programming of DBS systems is beneficial and useful for Parkinson's Disease (PD) patients, Parkinson's Foundation hosted a survey in collaboration with Abbott Labs. Methods: The survey was conducted to assess the need for telemedicine among PD patients with DBS and the usability of the telehealth interface for DBS teleprogramming. The survey included two validated instruments: The Effective Accessibility and Accommodation survey (EAA) and the Telehealth Usability Questionnaire (TUQ). Results: 47 patients completed the EAA and 41 completed the TUQ. Results from the EAA revealed more than a third of PD patients cannot easily get to a clinic for various reasons, and more than a quarter reported difficulty contacting their clinic for advice. Results from the TUQ revealed overall satisfaction with the DBS remote programming telehealth interface and care provided. The majority of respondents reported that remote tele-programming visits are similar in quality to in-person visits. Conclusion: This study provides support for the use of telehealth and tele-programming for DBS management in PD patients. The ability to use remote technologies for care will increase access to DBS and mitigate the disparities that currently prevent access to care.",
keywords = "Deep brain stimulation, Movement Disorders, Parkinson's disease, Telehealth, Teleprogramming",
author = "Esper, {Christine D.} and Aristide Merola and Lyndahl Himes and Neepa Patel and Bezchlibnyk, {Yarema B.} and Drew Falconer and Daniel Weiss and Corneliu Luca and Binith Cheeran and Zoltan Mari",
note = "Funding Information: This work was supported by Abbott Labs . The Sponsor assisted Parkinson's Foundation with recruiting participants by sharing the social medial post. Funding Information: C.D. Esper has received consultancy fees from NeuroOne Medical Technologies Corporation. A. Merola is supported by the NIH ( 1R01NS125386-01 ), receives compensation as Chief Editor for Frontiers in Neurology – Experimental Therapeutics, and has received consultancy or speaker fees from Abbott Laboratories, Abbvie, Boston Scientific, Lundbeck, and Theravance BioPharma. L. Himes and B. Cheeran are both employees of Abbott Labs. N. Patel has received honoraria as a consultant for Revanace Pharmaceutical, Acorda Pharmaceutical and Abbott Laboratories and as a speaker for Teva Pharmaceuticals. Y. B Bezchlibnyk is a paid consultant for PMT Corporation and receives consultancy or speaker fees from Abbott Laboratories, Boston Scientific, and Medtronic. D. Falconer has received consultancy or speaker fees from Abbott Laboratories, Abbvie, Amneal, Acorda, GE, Kyowa Kirin, Neurocrine, and Sunovion. Dr. Falconer also receives compensation as an FTC and Justice Department subject matter expert. D. Weiss received speaker honoraria from Abbott, Abbvie, Bial, Medtronic, served on advisory boards for Abbott, Kyowa Kirin, Stadapharm, and received institutional research support from Abbvie, Abbott, Bial, Boston Scientific, Medtronic, Michael J Fox Foundation, and German Research Foundation outside this work. C. Luca has consulting agreements with Boston Scientific, Inc., and Abbott. Z. Mari received consulting honoraria from AbbVie and Global Kinetics Corporation. Funding Information: While studies have demonstrated improved patient satisfaction with telemedicine in movement disorders [9], remote DBS programming is an emerging technology. Previous telemedicine approaches for DBS involved providing patients a range of preset stimulation parameters, previously determined by the clinician, that patients could access at home as needed or as directed during a telehealth session. Newer strategies involve remote programming guidance, allowing remote DBS specialists to guide programming done by a patient's local neurologist through a specialized interface (Heart Connect?, Boston Scientific). However, this platform does not allow for direct remote programming and must be conducted in-office. Research has also been conducted providing a mobile decision support system (MAP DBS) to non-expert home health nurse to make DBS stimulation changes in the PD patient's home [10]. These approaches contrast with synchronous, direct remote tele-programming. A recent multi-center study in China utilizing synchronous DBS tele-programming visits during the COVID-19 outbreak reported high patient satisfaction [11]; however, differences in technology, implementation, regulatory and data privacy policy may limit the relevance to clinical experience in other countries. This is also a limitation of this study, as software implementation changes in Neurosphere Virtual Clinic may be required to meet data privacy rules in Europe, for example, limiting the relevance of this US study. More studies evaluating the benefits in day-to-day life of patients, the impact on number of programing visits, side effects, cost and efficacy are necessary. ADROIT (Abbott DBS Post-Market Survey of Outcomes for Indications Over Time) is an ongoing multicenter clinical trial evaluating the long-term effectiveness of DBS in patients with movement disorders (NCT04071847). A sub-study of ADROIT (ROAM-DBS study; Remote Optimization, Adjustment, and Measurement for Deep Brain Stimulation) is underway to obtain clinical data on the time needed to optimize DBS stimulation parameters using the NeuroSphere Virtual Clinic software. This could provide clinicians with evidence on the time needed to achieve meaningful clinical benefit.C.D. Esper has received consultancy fees from NeuroOne Medical Technologies Corporation. A. Merola is supported by the NIH (1R01NS125386-01), receives compensation as Chief Editor for Frontiers in Neurology ? Experimental Therapeutics, and has received consultancy or speaker fees from Abbott Laboratories, Abbvie, Boston Scientific, Lundbeck, and Theravance BioPharma. L. Himes and B. Cheeran are both employees of Abbott Labs. N. Patel has received honoraria as a consultant for Revanace Pharmaceutical, Acorda Pharmaceutical and Abbott Laboratories and as a speaker for Teva Pharmaceuticals. Y. B Bezchlibnyk is a paid consultant for PMT Corporation and receives consultancy or speaker fees from Abbott Laboratories, Boston Scientific, and Medtronic. D. Falconer has received consultancy or speaker fees from Abbott Laboratories, Abbvie, Amneal, Acorda, GE, Kyowa Kirin, Neurocrine, and Sunovion. Dr. Falconer also receives compensation as an FTC and Justice Department subject matter expert. D. Weiss received speaker honoraria from Abbott, Abbvie, Bial, Medtronic, served on advisory boards for Abbott, Kyowa Kirin, Stadapharm, and received institutional research support from Abbvie, Abbott, Bial, Boston Scientific, Medtronic, Michael J Fox Foundation, and German Research Foundation outside this work. C. Luca has consulting agreements with Boston Scientific, Inc., and Abbott. Z. Mari received consulting honoraria from AbbVie and Global Kinetics Corporation.This work was supported by Abbott Labs. The Sponsor assisted Parkinson's Foundation with recruiting participants by sharing the social medial post. Publisher Copyright: {\textcopyright} 2022 The Authors",
year = "2022",
month = mar,
doi = "10.1016/j.parkreldis.2022.01.017",
language = "English (US)",
volume = "96",
pages = "38--42",
journal = "Parkinsonism and Related Disorders",
issn = "1353-8020",
publisher = "Elsevier BV",
}