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GALAXY (General Anesthesia vs. Local Anesthesia in stereotaXY) study

Completed
Conditions
Parkinson's Disease (PD)/ Ziekte van ParkinsonDeep Brain Stimulation (DBS)/ Diepe hersenstimulatieStereotaxy/ StereotaxieSubthalamic Nucleus (STN)/ Nucleus Subthalamicus
Registration Number
NL-OMON26420
Lead Sponsor
Academisch Medisch Centrum
Brief Summary

https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-017-2136-8

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
110
Inclusion Criteria

•Age > 18 years;

•Idiopathic PD with bradykinesia and at least two of the following signs; resting tremor, rigidity, and asymmetry;

Exclusion Criteria

•Legally incompetent adults;

•Previous PD-neurosurgery (e.g., DBS, pallidotomy, thalamotomy);

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The primary outcome measures is a composite score of the postoperative cognitive, mood and behavioral adverse effects.
Secondary Outcome Measures
NameTimeMethod
The secondary outcome measures consist of motor symptoms, adverse effects and complications, surgery time, functional health, quality of life, patient satisfaction on the outcome of treatment, patient evaluation of the burden of therapy, and medication
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