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

Authors
Category Primary study
Registry of TrialsNetherlands Trial Register
Year 2016
INTERVENTION: Patients will be randomized to DBS under general anesthesia or DBS under local anesthesia. For DBS, two electrodes will be implanted in the brain connected to an implanted pulse generator, which will be placed subcutaneously in the subclavian area. CONDITION: Parkinson's disease, Deep Brain Stimulation (DBS), Stereotaxy, Subthalamic Nucleus (STN) ; ; PRIMARY OUTCOME: The primary outcome measures is a composite score of the postoperative cognitive, mood and behavioral adverse effects. SECONDARY OUTCOME: 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 INCLUSION CRITERIA: • Age > 18 years; • Idiopathic PD with bradykinesia and at least two of the following signs; resting tremor, rigidity, and asymmetry; • Despite optimal pharmacological treatment, at least one of the following symptoms: severe response fluctuations, dyskinesias, painful dystonia or bradykinesia; • A life expectancy of at least two years.
Epistemonikos ID: 4b556e2b13099ac2f731c57f81a205c4d52cb52b
First added on: Aug 24, 2024