{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,3]],"date-time":"2026-07-03T13:36:38Z","timestamp":1783085798563,"version":"3.54.6"},"reference-count":20,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2023,10,18]],"date-time":"2023-10-18T00:00:00Z","timestamp":1697587200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2023,10,18]],"date-time":"2023-10-18T00:00:00Z","timestamp":1697587200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["BMC Neurol"],"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Background<\/jats:title>\n                <jats:p>The effectiveness of Deep Brain Stimulation (DBS) therapy for Parkinson\u2019s disease can be limited by side-effects caused by electrical current spillover into structures adjacent to the target area. The objective of the STEEred versus RING-mode DBS for Parkinson\u2019s disease (STEERING) study is to investigate if directional DBS for Parkinson\u2019s disease results in a better clinical outcome when compared to ring-mode DBS.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>The STEERING study is a prospective multi-centre double-blind randomised crossover trial. Inclusion criteria are Parkinson\u2019s disease, subthalamic nucleus DBS in a \u2018classic\u2019 ring-mode setting for a minimum of six months, and optimal ring-mode settings have been established. Participants are categorised into one of two subgroups according to their clinical response to the ring-mode settings as \u2018responders\u2019 (<jats:italic>i.e.<\/jats:italic>, patient with a satisfactory effect of ring-mode DBS) or \u2018non-responder\u2019 (<jats:italic>i.e.<\/jats:italic>, patient with a non-satisfactory effect of ring-mode DBS). A total of 64 responders and 38 non-responders will be included (total 102 patients). After an optimisation period in which an optimal directional setting is found, participants are randomised to first receive ring-mode DBS for 56\u00a0days (range 28\u201366) followed by directional DBS for 56\u00a0days (28\u201366) or vice-versa. The primary outcome is the difference between ring-mode DBS and directional DBS settings on the Movement Disorders Society Unified Parkinson\u2019s Disease Rating Scale \u2013 Motor Evaluation (MDS-UPDRS-ME) in the off-medication state. Secondary outcome measures consist of MDS-UPDRS-ME in the on-medication state, MDS-UPDRS Activities of Daily Living, MDS-UPDRS Motor Complications\u2013Dyskinesia, disease related quality of life measured with the Parkinson\u2019s Disease Questionnaire 39, stimulation-induced side-effects, antiparkinsonian medication use, and DBS-parameters. Participants\u2019 therapy preference is measured at the end of the study. Outcomes will be analysed for both responder and non-responder groups, as well as for both groups pooled together.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Discussion<\/jats:title>\n                <jats:p>The STEERING trial will provide insights into whether or not directional DBS should be standardly used in all Parkinson\u2019s disease DBS patients or if directional DBS should only be used in a case-based approach.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Trial registration<\/jats:title>\n                <jats:p>This trial was registered on the Netherlands Trial Register, as trial NL6508 (<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/www.onderzoekmetmensen.nl\/en\/trial\/22973\">NTR6696<\/jats:ext-link>) on June 23, 2017.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s12883-023-03387-0","type":"journal-article","created":{"date-parts":[[2023,10,18]],"date-time":"2023-10-18T05:01:40Z","timestamp":1697605300000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Directional versus ring-mode deep brain stimulation for Parkinson\u2019s disease: protocol of a multi-centre double-blind randomised crossover trial"],"prefix":"10.1186","volume":"23","author":[{"given":"Timo R. ten","family":"Brinke","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hannah","family":"Jergas","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vibuthi","family":"Sisodia","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael T.","family":"Barbe","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vincent J. 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Ethics approval was provided by the medical ethics committee (METC) of Amsterdam UMC, the Netherlands. Study monitoring will be performed in accordance with the ICH GCP guidelines. Written informed consent will be obtained from study participants.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"HJ reports personal fees from Boston scientific and has obtained funding from the K\u00f6ln Fortune program. MTB received speakers honoraria from Medtronic, Boston Scientific, Abbott (formerly St. Jude), FomF, GE Medical, UCB, Bial, Apothekerverband K\u00f6ln e.V., BDN, Esteve, and Ever. Research funding from the Felgenhauer-Stiftung, Forschungspool Klinische Studien (University of Cologne), Horizon 2020 (Gondola), Medtronic (ODIS, OPEL, BeAble), and Boston Scientific. He also received advisory honoraria for the IQWIG, Medtronic, Esteve and Abbvie. JMD received an unconditional supplementary grant from Medtronic for a randomized controlled trial comparing treatment with deep brain stimulation and continuous intrajejunal levodopa in advanced Parkinson\u2019s disease (INVEST study). Martijn Beudel received funding from the Amsterdam UMC TKI-PPP grant (2021 & 2023 call), the EU Joint Programme \u2013 Neurodegenerative Disease Research (JPND) project (2021 call) and Stichting ParkinsonFonds (2022 call). RMAB received funding for research, paid to the institution, from Medtronic. PRS is consultant for Boston Scientific, Medtronic and Elekta on educational matters. The other authors have no competing interests.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"372"}}