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Observational Study
. 2024 Jan 2;7(1):e2352177.
doi: 10.1001/jamanetworkopen.2023.52177.

Neurostimulation for Advanced Parkinson Disease and Quality of Life at 5 Years: A Nonrandomized Controlled Trial

Stefanie T Jost  1 , Salima Aloui  1 , Julian Evans  2 , Keyoumars Ashkan  3   4 , Anna Sauerbier  1 , Alexandra Rizos  3   4 , Jan Niklas Petry-Schmelzer  1 , Alexandra Gronostay  1 , Gereon R Fink  1   5 , Veerle Visser-Vandewalle  6 , Angelo Antonini  7 , Monty Silverdale  2 , Lars Timmermann  8 , Pablo Martinez-Martin  9 , K Ray Chaudhuri  3   4   10   11 , Haidar S Dafsari  1 ; International Parkinson and Movement Disorders Society Non-Motor Parkinson’s Disease Study Group and EUROPAR
Collaborators, Affiliations
Observational Study

Neurostimulation for Advanced Parkinson Disease and Quality of Life at 5 Years: A Nonrandomized Controlled Trial

Stefanie T Jost et al. JAMA Netw Open. .

Abstract

Importance: Deep brain stimulation of the subthalamic nucleus (STN-DBS) improves quality of life (QOL) in patients with advanced Parkinson disease (PD). However, controlled studies with more than 3 years of follow-up are lacking.

Objective: To investigate the long-term effects of STN-DBS on QOL compared with standard-of-care medication (MED).

Design, setting, and participants: In this prospective, observational, quasi-experimental, longitudinal nonrandomized controlled trial, 183 patients were screened for eligibility and 167 were enrolled from March 1, 2011, to May 31, 2017, at 3 European university centers. Propensity score matching for demographic and clinical characteristics was applied to 108 patients with PD (62 in the STN-DBS group and 46 in the MED group), resulting in a well-balanced, matched subcohort of 25 patients per group. Data analysis was performed from September 2022 to January 2023.

Exposure: Treatment for PD of STN-DBS or MED.

Main outcomes and measures: Assessments included Parkinson's Disease Questionnaire 8 (PDQ-8), Unified PD Rating Scale-motor examination, Scales for Outcomes in PD-activities of daily living (ADL) and motor complications, and levodopa-equivalent daily dose. Within-group longitudinal outcome changes, between-group differences, and correlations of change scores were analyzed.

Results: The study population in the analysis included 108 patients (mean [SD] age, 63.7 [8.3] years; 66 [61.1%] male). At 5-year follow-up, PDQ-8 and ADL worsened only in the MED group (PDQ-8 change, -10.9; 95% CI, -19.0 to -2.7; P = .01; ADL change: -2.0; 95% CI, -3.1 to -0.8; P = .002), whereas both outcomes remained stable in the STN-DBS group (PDQ-8 change, -4.3; 95% CI, -13.2 to 4.7; P = .34; ADL change, -0.8; 95% CI, -2.5 to 1.0; P = .38). Changes in PDQ-8 and ADL correlated moderately (rs = .40, P = .008). Furthermore, STN-DBS outcomes were favorable for motor complications (median difference in change scores between STN-DBS and MED, -2.0; 95% CI, -4.0 to -1.0; P = .003), mobility (-1.0; 95% CI, -2.0 to 0; P = .03), and levodopa-equivalent daily dose reduction (-821.4; 95% CI, -1111.9 to -530.8; P < .001).

Conclusions and relevance: This study provides evidence of differences in QOL outcomes at 5-year follow-up between STN-DBS (stable) and MED (worsened), mainly driven by the favorable effect of STN-DBS on mobility (class IIb evidence). The association between changes in QOL and ADL, but not motor impairment or complications, highlights the relative importance of ADL outcomes for long-term DBS assessments.

Trial registration: German ClinicalTrials Registry: DRKS00006735.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Jost reported receiving grants from the Prof. Klaus Thiemann Foundation and Brandau-Laibach-Foundation outside the submitted work. Dr Ashkan reported receiving grants from Medtronic and Abbott outside the submitted work. Dr Rizos reported receiving salary support from Movement Disorder Society and National Institute for Health Research Clinical Research Network outside the submitted work. Dr Petry-Schmelzer reported receiving grants from Deutsche Forschungsgemeinschaft. Dr Fink reported receiving grants from Deutsche Forschungsgemeinschaft during the conduct of the study. Dr Antonini reported receiving personal fees from Bial, AbbVie, Bayer, and from Nordic Infucare outside the submitted work. Dr Timmermann reported receiving grants from Boston Scientific and personal fees from Boston Scientific, AbbVie, Novartis, Neuraxpharm, Teva, Diaplan, and Movement Disorders Society during the conduct of the study and serving as the president of the German Society of Neurology outside the submitted work. Dr Martinez-Martin reported receiving personal fees from International Parkinson and Movement Disorder Society outside the submitted work. Dr Chaudhuri reported receiving grants from Parkinson’s Disease Non-Motor Group Grant for NILS study during the conduct of the study and personal fees from AbbVie, UCB, Bial, Global Kinetics Corporation, Cynapsus, Lobsor, Stada, Zambon, Profile Pharma, Synovion, Roche, Scion, Britannia Pharmaceuticals, Acadia, 4D Pharma, Novartis, Kyowa Kirin, and Boehringer Ingelheim and grants from EU (Horizon 2020), Parkinson’s UK, Parkinson’s Foundation, and Wellcome Trust outside the submitted work; in addition, Dr Chaudhuri had a patent for Non-Motor Symptoms of Parkinson’s Disease with royalties paid from Oxford University Press, a patent for Neuropsychiatric and Cognitive Changes in Parkinson’s Disease and Related Movement Disorders with royalties paid from Cambridge Publishers, a patent for KPPS, PDSS2 with royalties paid from Mapi, and a patent for Movement Disorders in Clinical Practice with royalties paid from Springer. Dr Dafsari reported receiving grants from EU Joint Programme – Neurodegenerative Disease Research, Prof. Klaus Thiemann Foundation in the German Society of Neurology, Felgenhauer Foundation, KoelnFortune program of the Medical Faculty of the University of Cologne, Everpharma, Kyowa Kirin, Bial, Oruen, and Stadapharm outside the submitted work and serving as the head of the Non-Motor Symptoms Study Group of the German Parkinson and Movement Disorder Foundation (unpaid). No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Patient Selection and Data Acquisition
DBS indicates deep brain stimulation; MED, standard-of-care medical treatment; MMSE, Mini-Mental State Examination; STN-DBS, deep brain stimulation of the subthalamic nucleus.
Figure 2.
Figure 2.. Domains of Quality of Life and Motor Aspects in the Patients Receiving Deep Brain Stimulation of the Subthalamic Nucleus (STN-DBS) vs Standard-of-Care Medical Treatment (MED)
For the Parkinson’s Disease Questionnaire 8 (PDQ-8), positive scores indicate improvement and negative scores indicate worsening. The PDQ-8 domain scores are illustrated as the percentage of maximum scores. More extensive areas represent more severe impairment. aSignificant longitudinal within-group changes among the 3 visits. bSignificant between-group differences at 5-year follow-up (STN-DBS vs MED).
See this image and copyright information in PMC

References

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