title: Stimulation of the subthalamic nucleus at an earlier disease stage of Parkinson's disease: concept and standards of the EARLYSTIM-study.
abstract: Deep brain stimulation (DBS) of the subthalamic nucleus (STN) is an established treatment for advanced Parkinson's disease (PD) with disabling motor complications. However, stimulation may be beneficial at an earlier stage of PD when motor fluctuations and dyskinesia are only mild and psychosocial competence is still maintained. The EARLYSTIM trial was conducted in patients with recent onset of levodopa-induced motor complications (≤ 3 years) whose social and occupational functioning remained preserved. This is called 'early' here. The study was a randomized, multicenter, bi-national pivotal trial with a 2 year observation period. Quality of life was the main outcome measure, and a video-based motor score was a blinded secondary outcome of the study. Motor, neuropsychological, psychiatric and psychosocial aspects were captured by established scales and questionnaires. The patient group randomized here is the earliest in the disease course and the youngest recruited in controlled DBS trials so far. The methodological innovation for DBS-studies of this study lies in novel procedures developed and used for monitoring best medical treatment, neurosurgical consistency, best management of stimulation programming, blinded video assessment of motor disability, and prevention of suicidal behaviors.
authors: Department of Neurology, Universitätsklinikum Schleswig-Holstein, Christian-Albrechts-University, Kiel, Germany. g.deuschl@neurologie.uni-kiel.de
authors: Günther
authors: G
authors: Deuschl
authors: Michael
authors: M
authors: Schüpbach
authors: Karina
authors: K
authors: Knudsen
authors: Marcus O
authors: MO
authors: Pinsker
authors: Philippe
authors: P
authors: Cornu
authors: Jörn
authors: J
authors: Rau
authors: Yves
authors: Y
authors: Agid
authors: Carmen
authors: C
authors: Schade-Brittinger
mesh_terms: D000328:Adult; D001519:Behavior / Q000502:physiology; D046690:Deep Brain Stimulation / Q000379:methods; D020820:Dyskinesias / Q000523:psychology / Q000628:therapy*; D004599:Electric Stimulation Therapy / Q000379:methods; D005260:Female; D006801:Humans; D007980:Levodopa / Q000494:pharmacology; D008297:Male; D008875:Middle Aged; D010300:Parkinson Disease / Q000523:psychology / Q000628:therapy*; D011788:Quality of Life / Q000523:psychology*; D012306:Risk; D020531:Subthalamic Nucleus / Q000502:physiology / Q000601:surgery*; D011795:Surveys and Questionnaires / Q000592:standards; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D007980:Levodopa