NASHVILLE, TN — More than a decade after deep brain stimulation (DBS), early-stage Parkinson’s disease (PD) patients appeared to have fewer motor complications than those treated only with medications, according to a new study.
A pilot clinical trial randomized 30 patients (Hoehn & Yahr II off; medication duration 0.5-4 years; without dyskinesia/motor fluctuations) to optimal drug therapy (ODT) (early ODT) or bilateral subthalamic nucleus (STN) DBS plus ODT (early DBS+ODT). A new study conducted by Vanderbilt University Medical Center in Nashville and Walter Reed National Military Center in Bethesda, MD, sought to determine the 11-year outcomes of patients who completed the DBS in the early-stage PD pilot clinical trial.
An article in the Neuromodulation journal noted that attempts were made to contact all 29 subjects who completed the two-year trial to participate in an 11-year follow-up study. Ultimately, 12 subjects participated in the follow-up—8 who received early ODT and 4 who received early DBS+ODT. Participants had a median age of 70 with a median PD medication duration of 13.7 years (median early DBS duration of 11.5 years in four of them.) Three early ODT subjects received STN-DBS as standard of care (DBS duration 6.5 ± 2.0 years), the researches pointed out.1
“Early ODT subjects had worse motor complications (Unified Parkinson’s Disease Rating Scale [UPDRS]-IV) than early DBS+ODT subjects over the 11-year follow-up period (between-group difference = 3.5 points; interaction = 0.03),” the authors advised. “Early DBS+ODT was well-tolerated after 11 years and showed comparable outcomes to early ODT for other UPDRS domains, Parkinson Disease Questionnaire-39 (PDQ-39), and levodopa equivalent daily dose (LEDD).”
“These results should be interpreted with caution, because only 40% of pilot trial subjects participated in this 11-year follow-up study,” the study noted. “The Food and Drug Administration has approved the conduct of a pivotal clinical trial evaluating DBS in early-stage PD (IDEG050016).”
- Hacker ML, Meystedt JC, Turchan M, Cannard KR, Harper K, Fan R, Ye F, Davis TL, Konrad PE, Charles D. Eleven-Year Outcomes of Deep Brain Stimulation in Early-Stage Parkinson Disease. Neuromodulation. 2023 Feb;26(2):451-458. doi: 10.1016/j.neurom.2022.10.051. Epub 2022 Dec 24. PMID: 36567243.
