Five-Year Outcomes from Deep Brain Stimulation of the Subthalamic Nucleus for Parkinson Disease.
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Starr Philip A, Shivacharan Rajat S, Goldberg Edward, Tröster Alexander I, House Paul A, Giroux Monique L, Hebb Adam O, Whiting Donald M, Leichliter Timothy A, Ostrem Jill L, Metman Leo Verhagen, Sani Sepehr, Karl Jessica A, Siddiqui Mustafa S, Tatter Stephen B, Haq Ihtsham Ul, Machado Andre G, Gostkowski Michal, Tagliati Michele, Mamelak Adam N, Okun Michael S, Foote Kelly D, Moguel-Cobos Guillermo, Ponce Francisco A, Pahwa Rajesh, Lyons Kelly, Buetefisch Cathrin M, Gross Robert E, Luca Corneliu C, Jagid Jonathan R, Revuelta Gonzalo J, Takacs Istvan, Pourfar Michael H, Mogilner Alon Y, Duker Andrew P, Mandybur George T, Rosenow Joshua M, Zadikoff Cindy, Khandhar Suketu M, Sedrak Mark, Phibbs Fenna T, Neimat Joseph, Durphy Jennifer, Ramirez-Zamora Adolfo, Pilitsis Julie G, Uitti Ryan J, Wharen Robert, Park Michael C, Vitek Jerrold L, INTREPID Study Group
Аннотация
OBJECTIVE: To evaluate the long-term (5-year) outcomes and safety of STN-DBS for PD.
DESIGN, SETTING, AND PARTICIPANTS: This was a prospective, randomized (3:1), 12-week double-blind sham-controlled study at 23 movement disorder centers across the US with an open-label 5-year follow-up. Patients were implanted and followed up with the Vercise DBS system from May 2013 to December 2022. Eligibility required diagnosis of bilateral idiopathic PD with more than 5 years of motor symptoms, more than 6 hours per day of poor motor function, modified Hoehn and Yahr Scale scores higher than 2, Unified Parkinson's Disease Rating Scale (UPDRS-III) score of 30 or higher (medication-off state), and 33% or higher improvement in UPDRS-III medication-on score.
INTERVENTION: Bilateral STN-DBS for moderate to advanced PD.
MAIN OUTCOMES AND MEASURES: Primary outcomes included changes in UPDRS and dyskinesia scores, quality-of-life measures, and safety assessments. Exploratory analyses included medication reduction and DBS association with motor signs.
RESULTS: A total of 313 patients were enrolled with 191 receiving the DBS system, and 137 participants (72%) completed the study. The study population had a mean (SD) age of 60 (7.9) years, with 139 (73%) male participants. Motor function without medication as measured by UPDRS-III improved from a mean (SD) of 42.8 (9.4) to 21.1 (10.6) at year 1 (51%; 95% CI, 49%-53%; P < .001) and 27.6 (11.6) at year 5 (36%; 95% CI, 33%-38%; P < .001). Activities of daily living without medication as measured by UPDRS-II improved from a mean (SD) of 20.6 (6.0) to 12.4 (6.1) at year 1 (41%; 95% CI, 38%-42%; P < .001) and 16.4 (6.5) at year 5 (22%; 95% CI, 18%-23%; P < .001). Dyskinesia scores decreased from 4.0 (5.1) to 1.0 (2.1) at year 1 (75%; 95% CI, 73%-75%; P < .001) and to 1.2 (2.1) at year 5 (70%; 95% CI, 63%-75%; P < .001). The levodopa equivalent dose was reduced by 28% at year 1, remaining stable at year 5 (28%; 95% CI, 26%-31%; P < .001). The most common serious adverse event was infection (9 participants). Ten deaths were reported, none related to the study.
CONCLUSIONS AND RELEVANCE: Although STN-DBS outcomes declined slightly, possibly due to the progressive nature of the disease, patients with PD sustained significant improvement in motor and activities of daily living scores, along with a stable reduction in anti-parkinsonian medication over the 5-year follow-up period.