Multiple-source current steering in subthalamic nucleus deep brain stimulation for Parkinson's disease (the VANTAGE study): A non-randomised, prospective, multicentre, open-label study

Lars Timmermann, Roshini Jain, Lilly Chen, Mohamed Maarouf, Michael T. Barbe, Niels Allert, Thomas Brücke, Iris Kaiser, Sebastian Beirer, Fernando Sejio, Esther Suarez, Beatriz Lozano, Claire Haegelen, Marc Vérin, Mauro Porta, Domenico Servello, Steven Gill, Alan Whone, Nic Van Dyck, Francois Alesch

Research output: Contribution to journalArticlepeer-review

Abstract

Background: High-frequency deep brain stimulation (DBS) with a single electrical source is effective for motor symptom relief in patients with Parkinson's disease. We postulated that a multiple-source, constant-current device that permits well defined distribution of current would lead to motor improvement in patients with Parkinson's disease. Methods: We did a prospective, multicentre, non-randomised, open-label intervention study of an implantable DBS device (the VANTAGE study) at six specialist DBS centres at universities in six European countries. Patients were judged eligible if they were aged 21-75 years, had been diagnosed with bilateral idiopathic Parkinson's disease with motor symptoms for more than 5 years, had a Hoehn and Yahr score of 2 or greater, and had a Unified Parkinson's disease rating scale part III (UPDRS III) score in the medication-off state of more than 30, which improved by 33% or more after a levodopa challenge. Participants underwent bilateral implantation in the subthalamic nucleus of a multiple-source, constant-current, eight-contact, rechargeable DBS system, and were assessed 12, 26, and 52 weeks after implantation. The primary endpoint was the mean change in UPDRS III scores (assessed by site investigators who were aware of the treatment assignment) from baseline (medication-off state) to 26 weeks after first lead implantation (stimulation-on, medication-off state). This study is registered with ClinicalTrials.gov, number NCT01221948. Findings: Of 53 patients enrolled in the study, 40 received a bilateral implant in the subthalamic nucleus and their data contributed to the primary endpoint analysis. Improvement was noted in the UPDRS III motor score 6 months after first lead implantation (mean 13·5 [SD 6·8], 95% CI 11·3-15·7) compared with baseline (37·4 [8·9], 34·5-40·2), with a mean difference of 23·8 (SD 10·6; 95% CI 20·3-27·3; p

Original languageEnglish
Pages (from-to)693-701
Number of pages9
JournalThe Lancet Neurology
Volume14
Issue number7
DOIs
Publication statusPublished - Jul 1 2015

ASJC Scopus subject areas

  • Clinical Neurology
  • Medicine(all)

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