Universität zu Köln

Lhommee, Eugenie, Wojtecki, Lars, Czernecki, Virginie, Witt, Karsten, Maier, Franziska, Tonder, Lisa, Timmermann, Lars, Haelbig, Thomas D., Pineau, Fanny, Durif, Franck, Witjas, Tatiana, Pinsker, Marcus, Mehdorn, Maximilian, Sixel-Doering, Friederike, Kupsch, Andreas, Krueger, Rejko, Elben, Saskia, Chabardes, Stephan, Thobois, Stephane, Brefel-Courbon, Christine, Ory-Magne, Fabienne, Regis, Jean-Marie, Maltete, David, Sauvaget, Anne, Rau, Jorn, Schnitzler, Alfons ORCID: 0000-0002-6414-7939, Schupbach, Michael, Schade-Brittinger, Carmen, Deuschl, Gunther ORCID: 0000-0002-4176-9196, Houeto, Jean-Luc and Krack, Paul (2018). Behavioural outcomes of subthalamic stimulation and medical therapy versus medical therapy alone for Parkinson's disease with early motor complications (EARLYSTIM trial): secondary analysis of an open-label randomised trial. Lancet Neurol., 17 (3). S. 223 - 232. NEW YORK: ELSEVIER SCIENCE INC. ISSN 1474-4465

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Abstract

Background Although subthalamic stimulation is a recognised treatment for motor complications in Parkinson's disease, reports on behavioural outcomes are controversial, which represents a major challenge when counselling candidates for subthalamic stimulation. We aimed to assess changes in behaviour in patients with Parkinson's disease receiving combined treatment with subthalamic stimulation and medical therapy over a 2-year follow-up period as compared with the behavioural evolution under medical therapy alone. Methods We did a parallel, open-label study (EARLYSTIM) at 17 surgical centres in France (n=8) and Germany (n=9). We recruited patients with Parkinson's disease who were disabled by early motor complications. Participants were randomly allocated (1: 1) to either medical therapy alone or bilateral subthalamic stimulation plus medical therapy. The primary outcome was mean change in quality of life from baseline to 2 years. A secondary analysis was also done to assess behavioural outcomes. We used the Ardouin Scale of Behavior in Parkinson's Disease to assess changes in behaviour between baseline and 2-year follow-up. Apathy was also measured using the Starkstein Apathy Scale, and depression was assessed with the Beck Depression Inventory. The secondary analysis was done in all patients recruited. We used a generalised estimating equations (GEE) regression model for individual items and mixed model regression for subscores of the Ardouin scale and the apathy and depression scales. This trial is registered with ClinicalTrials.gov, number NCT00354133. The primary analysis has been reported elsewhere; this report presents the secondary analysis only. Findings Between July, 2006, and November, 2009, 251 participants were recruited, of whom 127 were allocated medical therapy alone and 124 were assigned bilateral subthalamic stimulation plus medical therapy. At 2-year follow-up, the levodopa-equivalent dose was reduced by 39% (-363.3 mg/day [SE 41.8]) in individuals allocated bilateral subthalamic stimulation plus medical therapy and was increased by 21% (245.8 mg/day [40.4]) in those assigned medical therapy alone (p<0.0001). Neuropsychiatric fluctuations decreased with bilateral subthalamic stimulation plus medical therapy during 2-year follow-up (mean change -0.65 points [SE 0.15]) and did not change with medical therapy alone (-0.02 points [0.15]); the between-group difference in change from baseline was significant (p=0.0028). At 2 years, the Ardouin scale subscore for hyperdopaminergic behavioural disorders had decreased with bilateral subthalamic stimulation plus medical therapy (mean change -1.26 points [SE 0.35]) and had increased with medical therapy alone (1.12 points [0.35]); the between-group difference was significant (p<0.0001). Mean change from baseline at 2 years in the Ardouin scale subscore for hypodopaminergic behavioural disorders, the Starkstein Apathy Scale score, and the Beck Depression Inventory score did not differ between treatment groups. Antidepressants were stopped in 12 patients assigned bilateral subthalamic stimulation plus medical therapy versus four patients allocated medical therapy alone. Neuroleptics were started in nine patients assigned medical therapy alone versus one patient allocated bilateral subthalamic stimulation plus medical therapy. During the 2-year follow-up, two individuals assigned bilateral subthalamic stimulation plus medical therapy and one patient allocated medical therapy alone died by suicide. Interpretation In a large cohort with Parkinson's disease and early motor complications, better overall behavioural outcomes were noted with bilateral subthalamic stimulation plus medical therapy compared with medical therapy alone. The presence of hyperdopaminergic behaviours and neuropsychiatric fluctuations can be judged additional arguments in favour of subthalamic stimulation if surgery is considered for disabling motor complications.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Lhommee, Eugenie UNSPECIFIED UNSPECIFIED UNSPECIFIED Wojtecki, Lars UNSPECIFIED UNSPECIFIED UNSPECIFIED Czernecki, Virginie UNSPECIFIED UNSPECIFIED UNSPECIFIED Witt, Karsten UNSPECIFIED UNSPECIFIED UNSPECIFIED Maier, Franziska UNSPECIFIED UNSPECIFIED UNSPECIFIED Tonder, Lisa UNSPECIFIED UNSPECIFIED UNSPECIFIED Timmermann, Lars UNSPECIFIED UNSPECIFIED UNSPECIFIED Haelbig, Thomas D. UNSPECIFIED UNSPECIFIED UNSPECIFIED Pineau, Fanny UNSPECIFIED UNSPECIFIED UNSPECIFIED Durif, Franck UNSPECIFIED UNSPECIFIED UNSPECIFIED Witjas, Tatiana UNSPECIFIED UNSPECIFIED UNSPECIFIED Pinsker, Marcus UNSPECIFIED UNSPECIFIED UNSPECIFIED Mehdorn, Maximilian UNSPECIFIED UNSPECIFIED UNSPECIFIED Sixel-Doering, Friederike UNSPECIFIED UNSPECIFIED UNSPECIFIED Kupsch, Andreas UNSPECIFIED UNSPECIFIED UNSPECIFIED Krueger, Rejko UNSPECIFIED UNSPECIFIED UNSPECIFIED Elben, Saskia UNSPECIFIED UNSPECIFIED UNSPECIFIED Chabardes, Stephan UNSPECIFIED UNSPECIFIED UNSPECIFIED Thobois, Stephane UNSPECIFIED UNSPECIFIED UNSPECIFIED Brefel-Courbon, Christine UNSPECIFIED UNSPECIFIED UNSPECIFIED Ory-Magne, Fabienne UNSPECIFIED UNSPECIFIED UNSPECIFIED Regis, Jean-Marie UNSPECIFIED UNSPECIFIED UNSPECIFIED Maltete, David UNSPECIFIED UNSPECIFIED UNSPECIFIED Sauvaget, Anne UNSPECIFIED UNSPECIFIED UNSPECIFIED Rau, Jorn UNSPECIFIED UNSPECIFIED UNSPECIFIED Schnitzler, Alfons UNSPECIFIED orcid.org/0000-0002-6414-7939 UNSPECIFIED Schupbach, Michael UNSPECIFIED UNSPECIFIED UNSPECIFIED Schade-Brittinger, Carmen UNSPECIFIED UNSPECIFIED UNSPECIFIED Deuschl, Gunther UNSPECIFIED orcid.org/0000-0002-4176-9196 UNSPECIFIED Houeto, Jean-Luc UNSPECIFIED UNSPECIFIED UNSPECIFIED Krack, Paul UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-193531
Journal or Publication Title:	Lancet Neurol.
Volume:	17
Number:	3
Page Range:	S. 223 - 232
Date:	2018
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 DEEP-BRAIN-STIMULATION; IMPULSE CONTROL DISORDERS; NEUROPSYCHIATRIC SYMPTOMS; NONMOTOR FLUCTUATIONS; NUCLEUS STIMULATION; FOLLOW-UP; DEPRESSION; LEVODOPA; SURGERY; APATHY Multiple languages Clinical Neurology Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/19353