Category: Parkinson’s Disease: Clinical Trials
To determine the safety and tolerability of burst cycling deep brain stimulation (DBS) in Parkinson’s disease (PD) patients experiencing freezing of gait (FoG).
Background: DBS is a well-established therapy for control of tremor, motor fluctuations, and dyskinesia in PD. Specifically, DBS delivered via conventional high frequency stimulation (130-180Hz) is a robust symptomatic treatment for motor PD symptoms, However, this approach has limited beneficial effects on the axial symptoms including FoG. FoG is a debilitating feature of advanced PD and directly affects morbidity and quality of life and is often refractory to medications and/or DBS. Recently, alternate stimulation paradigms have been increasingly explored. One such pattern is burst cycling, in which trains of pulses are interrupted by pauses at regular intervals.
Method: We enrolled 10 PD subjects (8 males, 2 females) with globus pallidus interna (GPi) or subthalamic nucleus (STN) DBS optimized for control of tremor, rigidity, and bradykinesia with conventional setting but complaining of persistent FOG. A one-day in-office study involving random testing of 5 DBS conditions, in the off medication state was conducted. The 5 conditions were: baseline (home) settings, DBS off, 4, 10 and 15 Hz burst cycling. A washout period of 30 minutes was employed between each setting. The primary outcomes included assessment for side effect and tolerability, as well as blinded comparisons of timed-up and-go test (TUG).
Results: All participating subjects with age range of 53-76 years old and DBS surgery duration of 11-58 months experienced FoG before they received DBS surgery. Burst cycling stimulation was well-tolerated without any unanticipated side effects. 2 subjects withdrew early from the study due to inability to tolerate the long off medication time. Preliminary analysis shows no clinical worsening detected in UPDRS scores at experimental conditions. It appears that 10 Hz burst cycling may control gait dysfunction similar to baseline settings.
Conclusion: Burst cycling stimulation appears to be safe and well-tolerated in the acute setting. Subject fatigue over the course of the study has been found to be a limitation.
To cite this abstract in AMA style:W. Hu, J. Wang, R. Barmore, J. Melo Lobo, T. Tsuboi, A. Wang, A. Ramirez-Zamora, M. Okun, L. Almeida. Safety and Tolerability of Burst Cycling Deep Brain Stimulation for Freezing of Gait in Parkinson’s Disease [abstract]. Mov Disord. 2020; 35 (suppl 1). https://www.mdsabstracts.org/abstract/safety-and-tolerability-of-burst-cycling-deep-brain-stimulation-for-freezing-of-gait-in-parkinsons-disease/. Accessed November 29, 2023.
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