Objective: To describe the design of the ROAM-DBS trial which measures outcomes of remote programming using remote monitoring.

Background: A third of Parkinson’s Disease (PD) patients treated with DBS cannot easily travel to a clinic, and a quarter report difficulty contacting the clinic for advice[1]. Recently introduced DBS Remote Programming (RP) platforms[2-3] allow for DBS interrogation and programming remotely. The ROAM-DBS trial will compare time course of symptom changes and outcomes between RP and in-clinic programming.

Method: One hundred PD patients receiving de-novo Abbott DBS implants will be enrolled. After initial programming, participants will be randomized 1:1 to receive additional programming either in-clinic only or with RP and in-clinic visits as necessary. All participants will use a monitoring kit including a smartphone and smartwatch. The smartphone will measure the Patient’s Global Impression of Change (PGI-C) scale after each programming, PGI Severity (PGI-S) daily, PDQ-39 evaluations monthly for 3 months after initial programming, and a 3-month survey on access and burden of programming sessions. The smartwatch will continuously measure tremor amplitude, percent of time with dyskinesia, activity, heart rate and respiration rate. All participants will have MDS-UPDRS evaluations at 1 year after initial programming.

Results: The primary endpoint of ROAM-DBS is the time required after initial programming for a minimal clinically important difference of 1-point improvement in the PGI-C score. We hypothesize that RP could enable shorter intervals between early programming sessions to optimize settings, resulting in more rapid improvement in symptoms compared to in-clinic. Remote monitoring of patients will allow for continuous analysis of tremor and dyskinesia changes with low burden to patients and investigators. Additionally, PGI and PDQ-39 in the first 3 months after initial programming, will allow tracking of early changes in symptoms. Changes in MDS-UPDRS scores after 1 year will be compared to determine if similar outcomes are achieved in the two arms.

Conclusion: The ROAM-DBS trial will analyze whether RP results in more rapid improvement compared to in-clinic only follow-up. Remote monitoring will show the time course of changes in symptoms during the first 3 months after DBS implant and initial programming.

References: [1] C. Esper, A. Merola, L. Himes, N. Patel, Y. Bezchlibnyk, D. Falconer, D. Weiss, C. Luca, B. Cheeran, Z. Mari. Necessity and feasibility of remote tele-programming of deep brain stimulation systems in Parkinson’s disease. Parkinsonism and Related Disorders, 2022; 96:38-42. DOI: 10.1016/j.parkreldis.2022.01.017
[2] C. Zhang, K. Zhu, Z. Lin, P. Huang, Y. Pan, B. Sun, D. Li. Utility of Deep Brain Stimulation Telemedicine for Patients with Movement Disorders During the COVID-19 Outbreak in China. Neuromodulation 2021; 24: 337-342. DOI: 10.1111/ner.13274
[3] P. Silburn, S. DeBates, T. Tomlinson, J. Schwark, G. Creek, H. Patel, A. Punnoose, B. Cheeran, E. Ross, D. Lautner, Y. Pathak. Rapid development of an integrated remote programming platform for neuromodulation systems through the biodesign process. Scientific Reports 2022; 12:2269. DOI: 10.1038/s41598-022-06098-7

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MDS Abstracts - https://www.mdsabstracts.org/abstract/design-of-the-remote-optimization-adjustment-and-measurement-for-deep-brain-stimulation-roam-dbs-randomized-controlled-trial-using-decentralized-patient-monitoring/