Five-Year Outcomes from Deep Brain Stimulation of the Subthalamic Nucleus for Parkinson Disease
Document Type
Article
Abstract
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.
Medical Subject Headings
Humans; Parkinson Disease (therapy, physiopathology); Deep Brain Stimulation (methods, trends, adverse effects); Subthalamic Nucleus (physiology); Male; Female; Middle Aged; Double-Blind Method; Aged; Treatment Outcome; Prospective Studies; Follow-Up Studies
Publication Date
11-1-2025
Publication Title
JAMA neurology
E-ISSN
2168-6157
Volume
82
Issue
11
First Page
1181
Last Page
1190
PubMed ID
40952750
Digital Object Identifier (DOI)
10.1001/jamaneurol.2025.3373
Recommended Citation
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.; and Revuelta, Gonzalo J., "Five-Year Outcomes from Deep Brain Stimulation of the Subthalamic Nucleus for Parkinson Disease" (2025). Neurosurgery. 2264.
https://scholar.barrowneuro.org/neurosurgery/2264