Open AccessA Randomized, Double-Blinded Crossover Trial of Short Versus Conventional Pulse Width Subthalamic Deep Brain Stimulation in Parkinson’s Disease
Author(s) -
Jan Niklas PetrySchmelzer,
Lisa Schwarz,
Hannah Jergas,
Paul Reker,
Julia Steffen,
Haidar S. Dafsari,
Juan Carlos Baldermann,
Gereon R. Fink,
Veerle VisserVandewalle,
Till A. Dembek,
Michael T. Barbe
Publication year - 2022
Publication title -
journal of parkinson's disease/journal of parkinson's disease (online)
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.747
H-Index - 45
eISSN - 1877-718X
pISSN - 1877-7171
DOI - 10.3233/jpd-213119
Subject(s) - subthalamic nucleus , deep brain stimulation , stimulation , parkinson's disease , medicine , crossover study , pulse (music) , randomized controlled trial , physical medicine and rehabilitation , psychology , disease , surgery , placebo , physics , alternative medicine , pathology , detector , optics
Background: Subthalamic nucleus deep brain stimulation (STN-DBS) is a well-established treatment for patients with Parkinson’s disease. Previous acute challenge studies suggested that short pulse widths might increase the therapeutic window while maintaining motor symptom control with a decrease in energy consumption. However, only little is known about the effect of short pulse width stimulation beyond the setting of an acute challenge. Objective: To compare 4 weeks of STN-DBS with conventional pulse width stimulation (60μs) to 4 weeks of STN-DBS with short pulse width stimulation (30μs) regarding motor symptom control. Methods: This study was a monocentric, double-blinded, randomized crossover non-inferiority trial investigating whether short pulse width stimulation with 30μs maintains equal motor control as conventional 60μs stimulation over a period of 4 weeks (German Clinical Trials Register No. DRKS00017528). Primary outcome was the difference in motor symptom control as assessed by a motor diary. Secondary outcomes included energy consumption measures, non-motor effects, side-effects, and quality of life. Results: Due to a high dropout rate, the calculated sample size of 27 patients was not met and 24 patients with Parkinson’s disease and STN-DBS were included in the final analysis. However, there were no differences in any investigated outcome parameter between the two treatment conditions. Conclusion: This study demonstrates that short pulse width settings (30μs) provide non-inferior motor symptom control as conventional (60μs) stimulation without significant differences in energy consumption. Future studies are warranted to evaluate a potential benefit of short pulse width settings in patients with pronounced dyskinesia.