Category: Technology
Objective: To present early outcomes from the ROAM-DBS (Deep Brain Stimulation) trial on the clinical efficacy of teleprogramming for DBS demonstrating more rapid improvement when teleprogramming is included in DBS management.
Background: Newly introduced DBS remote programming platforms have the potential to reduce the burden of DBS management by enabling DBS device interrogation and programming remotely. The ROAM-DBS trial compares remote and in-clinic programming in the immediate post-operative period to investigate the impact of teleprogramming on the time-course of symptom improvement after DBS.
Method: The ROAM-DBS study is a multicenter, prospective randomized controlled trial for Parkinson’s Disease patients comparing in-clinic DBS programming only with remote DBS programming using Abbott’s Neurosphere™ Virtual Clinic platform. After each programming visit, participants are asked to evaluate their symptom improvement using the Patient’s Global Impression of Change (PGI-C), and clinicians rate symptoms using the Clinician’s Global Impression of Change (CGI-C). In addition, participants are asked to complete the PDQ-39 quality of life questionnaire monthly.
Results: As of March 7, 2023, a total of 82 patients have been enrolled in the ROAM study. Thus far 51 have completed the 3-month follow-up. Both arms report similar initial PDQ-39 quality of life scores of 26.8+/-11.8 in the remote arm compared to 25.8+/-13.6 (p=0.84). At 3-months, both arms show most subjects reporting improvement in PGI-C scores (remote arm: 23/26; in-clinic arm: 18/25, p=0.41). The remote arm shows a shorter time to improvement of 34.0+/-16.6 days compared to 46.8+/-19.1 days for the in-clinic arm (p<.05), and 2.8+/-2.4 programming visits compared to 1.25+/-1.1 visits in the clinic arm(p<.01). Similar outcomes are observed with the CGI-C, with 35.9+/-20.1 days to improve 1 point in the remote arm compared to 51.2+/-16.7 days for the in-clinic arm (p<.01).
Conclusion: Despite similar baseline symptoms, PD patients in the remote arm improved faster than the in-clinic arm. This suggests that easier [JK1] access to programming sessions enabled by teleprogramming reduces the time necessary to optimize DBS therapy. These early results highlight the potential improvements in DBS care using digital healthcare solutions.
To cite this abstract in AMA style:
A. Gharabaghi, D. Weiss, S. Groppa, L. Lopez Manzanares, A. Schnitzler, R. Alvarez, L. Muñoz-Delgado, C. Luca, J. Karl, V. Marshall, L. Zhang, M. Soileau, B. Dalm, M. Feldman, S. Zauber, H. Lei, L. Luo, B. Walter, C. Wu. Teleprogramming Reduces the Time Needed to Optimize DBS Therapy: Results from the ROAM-DBS study [abstract]. Mov Disord. 2023; 38 (suppl 1). https://www.mdsabstracts.org/abstract/teleprogramming-reduces-the-time-needed-to-optimize-dbs-therapy-results-from-the-roam-dbs-study/. Accessed November 24, 2024.« Back to 2023 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/teleprogramming-reduces-the-time-needed-to-optimize-dbs-therapy-results-from-the-roam-dbs-study/