Objective: We present preliminary outcomes from an ongoing prospective, on-label, multicenter outcomes study conducted in the United States of patients with directional Deep Brain Stimulation (DBS) Systems capable of multiple independent current control (MICC) for management of the motor symptoms of levodopa-responsive Parkinson’s disease (PD).

Background: Deep Brain Stimulation (DBS) is an effective strategy in reducing the motor complications in Parkinson’s disease (PD) as substantiated by several randomized controlled trials (Okun 2012, Schuepbach, 2013, Vitek 2020). This motor improvement has shown to be sustained for up to 10 years (Deuschl et al. 2013). Real-world data collected from a wide variety of implanting centers based on standard of care documenting overall  improvements in PD disease symptoms, quality of life may facilitate new insights regarding the real-world, clinical use and outcomes of DBS.

Method: Study participants are implanted with the Vercise DBS system (Boston Scientific), a multiple-source, constant-current system, and are assessed out to 3-years post-implantation where their overall improvement in quality of life and PD motor symptoms are evaluated. Clinical measures recorded at baseline and during study follow-up include (but may not be limited to) the following: Unified Parkinson’s disease Rating Scale (UPDRS), MDS-UPDRS, Parkinson’s disease Questionnaire (PDQ-39), Global Impression of Change and Non-Motor Symptom Assessment Scale (NMSS). Adverse events also collected.

Results: To date, a total of 82 subjects with Parkinson’s Disease have been enrolled in the study. Of these, 68 have received their DBS system. Subjects (mean age 63 ± 9 years; 62% males) reported a mean disease duration of 10.1 ± 5.4 years at time of consent. Baseline UPDRS III scores (meds off) of 38.3 ± 13.1 and quality of life (PDQ-39 Summary Index) indicate moderate to severe disease prior to DBS. Additional outcomes will be presented.

Conclusion: This large, US-based, patient outcomes study will provide for additional evidence capable of offering real-world insight regarding the clinical utilization of new MICC-based Directional DBS Systems for PD.

References: Okun MS, Gallo BV, Mandybur G, Jagid J, Foote KD, Revilla FJ, Alterman R, Jankovic J, Simpson R, Junn F, Verhagen L, Arle JE, Ford B, Goodman RR, Stewart RM, Horn S, Baltuch GH, Kopell BH, Marshall F, Peichel D, Pahwa R, Lyons KE, Tröster AI, Vitek JL, Tagliati M; SJM DBS Study Group. Subthalamic deep brain stimulation with a constant-current device in Parkinson’s disease: an open-label randomised controlled trial. Lancet Neurol. 2012 Feb;11(2):140-9.
Schuepbach WM, Rau J, Knudsen K, Volkmann J, Krack P, Timmermann L, Hälbig TD, Hesekamp H, Navarro SM, Meier N, Falk D, Mehdorn M, Paschen S, Maarouf M, Barbe MT, Fink GR, Kupsch A, Gruber D, Schneider GH, Seigneuret E, Kistner A, Chaynes P, Ory-Magne F, Brefel Courbon C, Vesper J, Schnitzler A, Wojtecki L, Houeto JL, Bataille B, Maltête D, Damier P, Raoul S, Sixel-Doering F, Hellwig D, Gharabaghi A, Krüger R, Pinsker MO, Amtage F, Régis JM, Witjas T, Thobois S, Mertens P, Kloss M, Hartmann A, Oertel WH, Post B, Speelman H, Agid Y, Schade-Brittinger C, Deuschl G; EARLYSTIM Study Group. Neurostimulation for Parkinson’s disease with early motor complications. N Engl J Med. 2013 Feb 14;368(7):610-22.
Deuschl G, Paschen S, Witt K. Clinical outcome of deep brain stimulation for Parkinson’s disease. Handb Clin Neurol. 2013;116:107-28. doi: 10.1016/B978-0-444-53497-2.00010-3. PMID: 24112889.

« Back to 2022 International Congress

MDS Abstracts - https://www.mdsabstracts.org/abstract/prospective-multicenter-real-world-outcomes-study-with-directional-deep-brain-stimulation-systems-in-the-treatment-of-parkinsons-disease/