Citations 1
Five-Year Outcomes from Deep Brain Stimulation of the Subthalamic Nucleus for Parkinson Disease
Starr, Philip A. , Shivacharan, Rajat S. , Goldberg, E. Matilda, Tröster, Alexander I. , House, P.A. , Giroux, Monique, Hebb, Adam O. , Whiting, Donald, Leichliter, Timothy, Ostrem, Jill L. , Metman, Leo Verhagen , Karl, Jessica , Siddiqui, Mustafa , Haq, Ihtsham , Moguel‐Cobos, Guillermo , Ponce, Francisco A. , Pahwa, Rajesh, Lyons, Kelly , Buetefisch, Cathrin M. , Luca, Corneliu , Jagid, Jonathan , Revuelta, Gonzalo J. , Takács, István , Pourfar, Michael , Mandybur, George, Zadikoff, Cindy , Khandhar, Suketu M., Sedrak, Mark , Phibbs, Fenna T., Neimat, Joseph S. , Durphy, Jennifer, Ramirez‐Zamora, Adolfo , Pilitsis, Julie G. , Uitti, Ryan J. , Wharen, Robert E. , Park, Michael C. , Vitek, Jerrold L. , Group, INTREPID Study, Galifianakis, Nicholas B. , Schrock, Lauren E. , Farris, Sierra, Nazzarro, Jules M., Haq, Ihtsham , Ramirez-Zamora, Adolfo , Goldberg, Edward, Sani, Sepehr , Tatter, Stephen B. , Machado, André G. , Gostkowski, Michał , Tagliati, Michele , Mamelak, Adam N. , Okun, Michael S. , Foote, Kelly D. , Pahwa, Rajesh , Gross, Robert E. , Takacs, Istvan, Mogilner, Alon Y. , Duker, Andrew , Rosenow, Joshua M. , Group, INTREPID Study, Luciano, Marta San , Cooper, Scott E.
JAMA Neurology | September 15, 2025 | Volume: 82 | Issue: 11 | Pages: 1181
Importance The Implantable Neurostimulator for the Treatment of Parkinson’s Disease (INTREPID) trial was a randomized, double-blind, sham-controlled study of subthalamic nucleus (STN) deep brain stimulation (DBS) for the treatment of Parkinson disease (PD). 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.