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Abstract
Objective To report 5-year outcomes from the subthalamic nucleus (STN) deep brain stimulation (DBS) in early-stage Parkinson disease (PD) pilot clinical trial.
Methods The pilot was a prospective, single-blind clinical trial that randomized patients with early-stage PD (Hoehn & Yahr II off medications) to receive bilateral STN DBS plus optimal drug therapy (ODT) vs ODT alone (IDEG050016, NCT0282152, IRB040797). Participants who completed the 2-year trial participated in this observational follow-up study, which included annual outpatient visits through 5 years. This analysis includes 28 patients who were taking PD medications for 6 months to 4 years at enrollment. Outcomes were analyzed using both proportional odds logistic regression and linear mixed effects models.
Results Early STN DBS + ODT participants required lower levodopa equivalent daily doses (p = 0.04, β = −240 mg, 95% confidence interval [CI] −471 to −8) and had 0.06 times the odds of requiring polypharmacy at 5 years compared to early ODT participants (p = 0.01, odds ratio [OR] 0.06, 95% CI 0.00 to 0.65). The odds of having worse rest tremor for early STN DBS + ODT participants were 0.21 times those of early ODT participants (p < 0.001, OR 0.21, 95% CI 0.09 to 0.45). The safety profile was similar between groups.
Conclusions These results suggest that early DBS reduces the need for and complexity of PD medications while providing long-term motor benefit over standard medical therapy. Further investigation is warranted, and the Food and Drug Administration has approved the conduct of a prospective, multicenter, pivotal clinical trial of DBS in early-stage PD (IDEG050016).
Classification of evidence This study provides Class II evidence that DBS implanted in early-stage PD decreases the risk of disease progression and polypharmacy compared to optimal medical therapy alone.
Glossary
- AE=
- adverse event;
- CI=
- confidence interval;
- CRC=
- Clinical Research Center;
- DBS=
- deep brain stimulation;
- FDA=
- Food and Drug Administration;
- IPG=
- implanted pulse generator;
- IRB=
- institutional review board;
- LEDD=
- levodopa equivalent daily dose;
- ODT=
- optimal drug therapy;
- OR=
- odds ratio;
- PD=
- Parkinson disease;
- PDQ-39=
- Parkinson's Disease Questionnaire–39;
- STN=
- subthalamic nucleus;
- TEED=
- total electrical energy delivered;
- UPDRS-III=
- Unified Parkinson's Disease Rating Scale, part III
Footnotes
Go to Neurology.org/N for full disclosures. Funding information and disclosures deemed relevant by the authors, if any, are provided at the end of the article.
See Patient Page e436
Class of Evidence: NPub.org/coe
Podcast: NPub.org/0bysrd
- Received September 6, 2019.
- Accepted in final form January 26, 2020.
- © 2020 American Academy of Neurology
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