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General Anesthesia versus Local Anesthesia in StereotaXY (GALAXY) for Parkinson’s disease: study protocol for a randomized controlled trial

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Title
General Anesthesia versus Local Anesthesia in StereotaXY (GALAXY) for Parkinson’s disease: study protocol for a randomized controlled trial
Published in
Trials, September 2017
DOI 10.1186/s13063-017-2136-8
Pubmed ID
Authors

R. A. Holewijn, D. Verbaan, R. M. A. de Bie, P. R. Schuurman

Abstract

The aim of the study is to investigate if deep brain stimulation (DBS) in the subthalamic nucleus (STN) for Parkinson's disease (PD) under general anesthesia further improves outcome by lessening postoperative cognitive, mood, and behavioral adverse effects; shorten surgical time and hospital admittance; and produce comparable symptomatic and functional improvement to surgery under local anesthesia. The study will be a single-center, prospective, randomized, open-label, blinded endpoint trial comparing DBS under general anesthesia with DBS under local anesthesia. The primary outcome measure is a composite score of the postoperative cognitive, mood, and behavioral adverse effects and will be measured 6 months after surgery. The secondary outcome measures consist of changes in motor symptoms, adverse effects of stimulation and surgical complications, surgical time, functional health, quality of life, patient satisfaction with the outcome of treatment, patient evaluation of the burden of therapy, and medication. A total of 110 patients with advanced PD who are candidates for DBS will be randomized during a 2.5-year period. The aim of this trial is to further enhance the effectiveness of DBS treatment in PD while reducing the burden of DBS surgery by studying if DBS surgery under general anesthesia results in less cognitive, mood, and behavioral adverse effects compared with surgery under local anesthesia. Netherlands Trial Register, NTR5809 . Registered on 23 April 2016.

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Geographical breakdown

Country Count As %
Unknown 100 100%

Demographic breakdown

Readers by professional status Count As %
Student > Bachelor 18 18%
Student > Master 12 12%
Other 8 8%
Researcher 7 7%
Student > Doctoral Student 4 4%
Other 14 14%
Unknown 37 37%
Readers by discipline Count As %
Medicine and Dentistry 27 27%
Nursing and Health Professions 13 13%
Neuroscience 6 6%
Psychology 4 4%
Unspecified 3 3%
Other 9 9%
Unknown 38 38%