Universität zu Köln

Timmermann, Lars, Jain, Roshini, Chen, Lilly, Maarouf, Mohamed, Barbe, Michael T., Allert, Niels, Bruecke, Thomas, Kaiser, Iris, Beirer, Sebastian, Sejio, Fernando, Suarez, Esther, Lozano, Beatriz, Haegelen, Claire, Verin, Marc, Porta, Mauro, Servello, Domenico ORCID: 0000-0002-0123-1615, Gill, Steven, Whone, Alan ORCID: 0000-0002-8931-4422, Van Dyck, Nic and Alesch, Francois (2015). 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. Lancet Neurol., 14 (7). S. 693 - 702. NEW YORK: ELSEVIER SCIENCE INC. ISSN 1474-4465

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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<0.0001). One patient died of pneumonia 24 weeks after implantation, which was judged to be unrelated to the procedure. 125 adverse events were reported, the most frequent of which were dystonia, speech disorder, and apathy. 18 serious adverse events were recorded, three of which were attributed to the device or procedure (one case each of infection, migration, and respiratory depression). All serious adverse events resolved without residual effects and stimulation remained on during the study. Interpretation The multiple-source, constant-current, eight-contact DBS system suppressed motor symptoms effectively in patients with Parkinson's disease, with an acceptable safety profile. Future trials are needed to investigate systematically the potential benefits of this system on postoperative outcome and its side-effects.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Timmermann, Lars UNSPECIFIED UNSPECIFIED UNSPECIFIED Jain, Roshini UNSPECIFIED UNSPECIFIED UNSPECIFIED Chen, Lilly UNSPECIFIED UNSPECIFIED UNSPECIFIED Maarouf, Mohamed UNSPECIFIED UNSPECIFIED UNSPECIFIED Barbe, Michael T. UNSPECIFIED UNSPECIFIED UNSPECIFIED Allert, Niels UNSPECIFIED UNSPECIFIED UNSPECIFIED Bruecke, Thomas UNSPECIFIED UNSPECIFIED UNSPECIFIED Kaiser, Iris UNSPECIFIED UNSPECIFIED UNSPECIFIED Beirer, Sebastian UNSPECIFIED UNSPECIFIED UNSPECIFIED Sejio, Fernando UNSPECIFIED UNSPECIFIED UNSPECIFIED Suarez, Esther UNSPECIFIED UNSPECIFIED UNSPECIFIED Lozano, Beatriz UNSPECIFIED UNSPECIFIED UNSPECIFIED Haegelen, Claire UNSPECIFIED UNSPECIFIED UNSPECIFIED Verin, Marc UNSPECIFIED UNSPECIFIED UNSPECIFIED Porta, Mauro UNSPECIFIED UNSPECIFIED UNSPECIFIED Servello, Domenico UNSPECIFIED orcid.org/0000-0002-0123-1615 UNSPECIFIED Gill, Steven UNSPECIFIED UNSPECIFIED UNSPECIFIED Whone, Alan UNSPECIFIED orcid.org/0000-0002-8931-4422 UNSPECIFIED Van Dyck, Nic UNSPECIFIED UNSPECIFIED UNSPECIFIED Alesch, Francois UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-400474
DOI:	10.1016/S1474-4422(15)00087-3
Journal or Publication Title:	Lancet Neurol.
Volume:	14
Number:	7
Page Range:	S. 693 - 702
Date:	2015
Publisher:	ELSEVIER SCIENCE INC
Place of Publication:	NEW YORK
ISSN:	1474-4465
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language CORE ASSESSMENT PROGRAM; MEDICAL THERAPY; IMPEDANCE; TRIALS Multiple languages Clinical Neurology Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/40047