Article
Directional versus omnidirectional deep brain stimulation for Parkinson’s disease – 12-month results of a multi-centre, prospective, blinded, crossover study
Direktionale versus omnidirektionale Tiefenhirnstimulation beim M. Parkinson – 12-Monatsergebnisse einer prospektiven, verblindeten, Cross-over-Multicenter Studie
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Authors
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Jan Vesper
- Heinrich-Heine-Universität Düsseldorf, Sektion Stereotaktische und Funktionelle Neurochirurgie, Düsseldorf, Deutschland
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Philipp J. Slotty
- Heinrich-Heine-Universität Düsseldorf, Sektion Stereotaktische und Funktionelle Neurochirurgie, Düsseldorf, Deutschland
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Stefan Jun Groiss
- Heinrich-Heine-Universität Düsseldorf, Zentrum für Bewegungsstörung und Neuromodulation, Düsseldorf, Deutschland
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Alfons Schnitzler
- Heinrich-Heine-Universität Düsseldorf, Zentrum für Bewegungsstörung und Neuromodulation, Düsseldorf, Deutschland
| Published: | June 26, 2020 |
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Outline
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Objective: Deep Brain Stimulation (DBS) has been delivered through circumferential electrodes for over a quarter century to treat symptoms of levodopa-responsive Parkinson’s disease. Recently introduced directional leads for DBS have the two middle rings divided into three segments, which allows for axially asymmetric stimulation. The Infinity DBS system (Abbott) delivers conventional omnidirectional stimulation to all three segments of the ring, or directional stimulation to only one or two segments. PROGRESS is the first large, prospective, multi‑center study conducted to evaluate safety and clinical performance of directional DBS.
Methods: Directional and omnidirectional stimulation were compared in 66 subjects receiving DBS in the subthalamic nucleus for Parkinson’s disease. Subjects were programmed with omnidirectional stimulation for 3 months, followed by directional for 3 months and blinded to stimulation type for the first 6 months. The primary endpoint was the difference in therapeutic window (TW) for directional vs. omnidirectional stimulation assessed at the 3-month follow-up visit. Subjects were blinded to stimulation type for the first 6 months, and a blinded assessment was made for therapeutic window. Additional endpoints included blinded UPDRS part III motor examination scores, UPDRS part II for activity of daily living, PDQ-39 for quality of life, safety, subject and clinician stimulation preference and subject and programmer satisfaction with product usability.
Results: There was a wider TW for directional stimulation in 59 of 66 subjects (89.4%), meeting the endpoints for both non-inferiority and superiority. Single-segment activation produced wider TW than omnidirectional stimulation in 56 of 66 subjects (84.8%). Directional stimulation was able to produce a 35% wider TW, and therapeutic current strength was 30% lower using the optimal directional configuration. When asked for their preferred period, more than 2 times as many subjects and 4 times as many clinicians chose the period using directional stimulation.
Conclusion: PROGRESS met its superiority endpoint, with 89.4% of subjects having a wider TW using directional DBS stimulation. This international prospective blinded crossover study is the largest clinical evaluation of directional DBS to date.
