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

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 pa...

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Published in:Lancet neurology 2018-03, Vol.17 (3), p.223-231
Main Authors: Wojtecki, Lars, Czernecki, Virginie, Witt, Karsten, Maier, Franziska, Tonder, Lisa, Timmermann, Lars, Hälbig, Thomas D, Pineau, Fanny, Durif, Franck, Witjas, Tatiana, Pinsker, Marcus, Mehdorn, Maximilian, Sixel-Döring, Friederike, Kupsch, Andreas, Krüger, Rejko, Elben, Saskia, Chabardès, Stephan, Thobois, Stéphane, Brefel-Courbon, Christine, Ory-Magne, Fabienne, Regis, Jean-Marie, Maltête, David, Sauvaget, Anne, Rau, Jörn, Schnitzler, Alfons, Schüpbach, Michael, Schade-Brittinger, Carmen, Deuschl, Gunther, Houeto, Jean-Luc, Krack, Paul, Negovanska, Velina, Welter, Marie-Laure, Corvol, Jean-Christophe, Agid, Yves, Meier, Niklaus, Hartmann, Andreas, Hesekamp, Helke, Cornu, Philippe, Möller, Bettina, Nebel, Adelheid, Raethjen, Jan, Knudsen, Karina, Volkmann, Jens, Falk, Daniela, Paschen, Steffen, Meister, Ingo, Kuhn, Jens, Donner, Kerstin, Kessler, Josef, Barbe, Michael, Fink, Gereon, Maarouf, Mohammad, Kühn, Andrea, Müller, Bianca, Faust, Katharina, Gruber, Doreen, Schneider, Gerd-H., Seigneuret, Eric, Pollak, Pierre, Fraix, Valerie, Kistner, Andrea, Rascol, Olivier, Arbus, Christophe, Danet, Lola, Chaynes, Patrick, Groiss, Stefan J., Hartmann, Christian, Südmeyer, Martin, Partowinia-Peters, Mahnaz, Ledily, Severine, Damier, Philippe, Raoul, Sylvie, Trenkwalder, Claudia, Richter-Dreske, Wenke, Wächter, Tobias, Weiss, Daniel, Eusebio, Alexandro, Polo, Gustavo, Pinto, Serge, Dornier, Stephanie, Pene, Fredy, Hourton, Delphine, Quintin, Mathieu, Hoffart-Jourdain, Cecile, Brocvielle, Helene, Balthasar, Kerstin, Stein, Meryem, Harnisch, Susanne, Reuss, Alexander, Aminossadati, Behnaz, Nasemann, Christian, Oertel, Wolfgang, Bataille, Benoit, Hellwig, Dieter, Gharabaghi, Alireza, Amtage, Florian, Mertens, Patrick, Kloss, Manja, Post, Bart, Speelman, Hans
Format: Article
Language:English
Subjects:
Addictions
Addictive behaviors
Adult
Antiparkinson Agents - therapeutic use
Anxiety
Apathy
Behavior
Brain research
Candidates
Cognitive science
Cognitive Sciences
Cohort Studies
Deep Brain Stimulation - methods
Dopamine
Female
France
Germany
Humans
Impulsivity
International Cooperation
Levodopa - therapeutic use
Life Sciences
Male
Medical treatment
Middle Aged
Motor Activity - drug effects
Motor Activity - physiology
Movement disorders
Neurobiology
Neurodegenerative diseases
Neurons and Cognition
Neuroscience
Parkinson Disease - physiopathology
Parkinson Disease - therapy
Parkinson's disease
Psychiatric Status Rating Scales
Psychiatry
Psychology and behavior
Severity of Illness Index
Subthalamic Nucleus - physiology
Surgery
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Summary: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. 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. 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
ISSN:1474-4422
1474-4465
DOI:10.1016/S1474-4422(18)30035-8